Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT01576003
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2012-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012778', 'term': 'Short Bowel Syndrome'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D000409', 'term': 'Alanine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'conrad.cole@cchmc.org', 'phone': '513-636-6155', 'title': 'Conrad R. Cole, MD', 'organization': "Cincinnati Children's Hospital Medical Center"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Recruitment was low due to the improvement in care from the use of ethanol lock therapy and improved techniques related to line care. Early termination of participants lead to small number of subjects analyzed and inability to analyze all study aims.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Glutamine', 'description': 'L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Healthy Control', 'description': 'No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diaper Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Central Venous Catheter (CVC) dislodged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash Maculopapular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Viral Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for fever in a patient with a central line', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus (RSV)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Bloodstream Infections (BSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine', 'description': 'Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Evaluate the efficacy of enteral Glutamine supplementation to decrease bloodstream infections in participants that are parenteral nutrition dependent with Short Bowel Syndrome due to necrotizing enterocolitis (NEC) and/or atresia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the five participants analyzed completed the study. Healthy controls did not receive parenteral nutrition and were not analyzed in this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Length Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine', 'description': 'L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)'}], 'classes': [{'title': 'Length at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '65.0'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '63.2', 'upperLimit': '70.8'}]}]}, {'title': 'Length at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '71.4'}]}]}, {'title': 'Length at Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '73.7', 'groupId': 'OG001'}]}]}, {'title': 'Length at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '78.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed at Baseline and days 60, 120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.'}, {'type': 'SECONDARY', 'title': 'Head Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine', 'description': 'L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)'}], 'classes': [{'title': 'Head Circumference at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '41.1', 'upperLimit': '44.8'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '42.2', 'upperLimit': '46.8'}]}]}, {'title': 'Head Circumference at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000'}, {'value': '43.4', 'groupId': 'OG001', 'lowerLimit': '42.0', 'upperLimit': '44.8'}]}]}, {'title': 'Head Circumference at Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Head Circumference at day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}, {'value': '46.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed at Baseline and days 60, 120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.'}, {'type': 'SECONDARY', 'title': 'Mid Arm Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine', 'description': 'L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)'}], 'classes': [{'title': 'Mid Arm Circumference at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '15.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '16.0'}]}]}, {'title': 'Mid Arm Circumference at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '16.3'}]}]}, {'title': 'Mid Arm Circumference at Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Mid Arm Circumference at day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed at Baseline and days 60,120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.'}, {'type': 'SECONDARY', 'title': 'Weight Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine', 'description': 'L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)'}], 'classes': [{'title': 'Weight at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '7.9'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '9.2'}]}]}, {'title': 'Weight at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '9.0'}]}]}, {'title': 'Weight at Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Weight at day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed at Baseline and days 60, 120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glutamine', 'description': 'L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)'}, {'id': 'FG002', 'title': 'Healthy Control', 'description': 'No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'One participant consented and then withdrew prior completing any study procedure. This participant is not included in the participant flow due to the fact no study procedures or randomization occurred.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Glutamine', 'description': 'L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'L-Alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)'}, {'id': 'BG002', 'title': 'Healthy Control', 'description': 'No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6 weeks through 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': '3 months through 4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': '5 months through 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': '7 months through 8 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': '9 months through 10 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': '11 months through 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cause of Short Bowel Resection', 'classes': [{'title': 'Atresia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Necrotizing enterocolitis (NEC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'NEC and Atresia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'BG000', 'lowerLimit': '1.85', 'upperLimit': '2.9'}, {'value': '2.6', 'groupId': 'BG001', 'lowerLimit': '2.3', 'upperLimit': '2.9'}, {'value': '2.35', 'groupId': 'BG003', 'lowerLimit': '1.85', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Birth weight data was not obtained on healthy controls.'}, {'title': 'Bowel Length', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'BG000', 'lowerLimit': '33.0', 'upperLimit': '66.0'}, {'value': '82.0', 'groupId': 'BG001', 'lowerLimit': '45.0', 'upperLimit': '150.0'}, {'value': '69.0', 'groupId': 'BG003', 'lowerLimit': '33.0', 'upperLimit': '150'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Healthy Controls did not have a bowel resection.'}], 'populationDescription': '1 Participant withdrew in the screening phase and did not randomize.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-01', 'size': 473462, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-22T11:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2012-04-10', 'resultsFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2012-04-11', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-08', 'studyFirstPostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Bloodstream Infections (BSI)', 'timeFrame': '6 months', 'description': 'Evaluate the efficacy of enteral Glutamine supplementation to decrease bloodstream infections in participants that are parenteral nutrition dependent with Short Bowel Syndrome due to necrotizing enterocolitis (NEC) and/or atresia.'}, {'measure': 'Length Velocity', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.'}], 'secondaryOutcomes': [{'measure': 'Head Circumference', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference'}, {'measure': 'Mid Arm Circumference', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.'}, {'measure': 'Weight Velocity', 'timeFrame': '6 months', 'description': 'Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Short Bowel Syndrome', 'Necrotizing Entercolitis (NEC)', 'Atresia', 'Parenteral Nutrition', 'Biological Markers', 'Growth'], 'conditions': ['Bloodstream Infections', 'Short Bowel Syndrome', 'Development', 'Nutrition', 'Biological Markers']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.", 'detailedDescription': 'This is a double-blind, randomized placebo-controlled pilot study to investigate the efficacy of enteral glutamine (GLN) supplementation in 36 infants, ≤ 12 months of age with parenteral nutrition (PN)-dependent short bowel syndrome (SBS) due to massive small bowel resection for NEC and/or atresia on improving weaning of PN and preventing infections. The investigators intend to evaluate the effect of enteral feeding and GLN supplementation on the gut bacteria. The investigators will also recruit 12 age-matched controls to evaluate the normal gut bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Controls:\n\n* Less than or equal to 12 months of age\n* Normal small bowel length without any intestinal resection or primary intestinal disease\n* Not currently on Total Parenteral Nutrition (TPN) and if ever on TPN this should have been discontinued for at least 4 weeks.\n\nExclusion Criteria for Controls:\n\n* Major congenital or chromosomal anomalies\n* Inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula\n* History of liver/intestinal transplantation\n\nInclusion Criteria for Glutamine and Placebo Group of Short Bowel Syndrome (SBS) Patients:\n\n* Less than or equal to 12 months of age\n* Patients who have undergone small bowel resection due to necrotizing enterocolitis (NEC) or intestinal atresia with known small bowel length\n* Patients who have been Parenteral Nutrition (PN) dependent for more than 42 consecutive days and currently on TPN at time of enrollment\n* Patients who have the ability to take partial enteral nutrition or breast milk or elemental formula to allow the appropriate dose of glutamine or placebo\n* Signed informed consent for the use of Glutamine or placebo\n\nExclusion Criteria for Glutamine and Placebo Group of SBS Patients:\n\n* Major congenital or chromosomal anomalies\n* Inability to tolerate enteral nutrition that will preclude treatment with enteral Glutamine or L-alanine placebo for \\> 2 weeks\n* Liver/Intestinal transplantation"}, 'identificationModule': {'nctId': 'NCT01576003', 'briefTitle': 'Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants', 'orgStudyIdInfo': {'id': '2010-2706'}, 'secondaryIdInfos': [{'id': '1R21DK088027-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21DK088027-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glutamine', 'description': 'Infants randomized to the Glutamine group will receive L-Glutamine (GLN) administered enterally at a dose of 0.6g/kg body weight/day (0.3g/kg/dose) in 2 divided daily doses for 6 months. GLN will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day).', 'interventionNames': ['Drug: Glutamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'L-alanine', 'description': 'Infants randomized to the placebo group will receive L-alanine (ALA) administered enterally at a dose of 0.6g/kg body weight/day in 2 divided doses (0.3g/kg/day twice a day) for 6 months. ALA will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day).', 'interventionNames': ['Dietary Supplement: L-alanine']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Control', 'description': 'Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.'}], 'interventions': [{'name': 'Glutamine', 'type': 'DRUG', 'otherNames': ['NutreStore'], 'description': '0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)', 'armGroupLabels': ['Glutamine']}, {'name': 'L-alanine', 'type': 'DIETARY_SUPPLEMENT', 'description': '0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)', 'armGroupLabels': ['L-alanine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C.S. Mott Children's Hosptial", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Conrad R Cole, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Emmaus Medical, Inc.', 'class': 'INDUSTRY'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}