Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-25 @ 2:43 AM
Study NCT ID:
NCT02475369
Status:
TERMINATED
Last Update Posted:
2021-05-12
First Post:
2015-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pancreatic Enzyme Supplementation for Celiac Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020799', 'term': 'Pancrelipase'}, {'id': 'D008049', 'term': 'Lipase'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D000681', 'term': 'Amylases'}], 'ancestors': [{'id': 'D002265', 'term': 'Carboxylic Ester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010184', 'term': 'Pancreatic Extracts'}, {'id': 'D014020', 'term': 'Tissue Extracts'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cbarret5@bidmc.harvard.edu', 'phone': '617-667-8266', 'title': 'Caitlin Barrett', 'organization': 'BIDMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination by the sponsor leading to a small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Patients were followed for 34 days which was the entire duration of the study.', 'description': 'Anticipated and unanticipated deaths, serious adverse events, and other adverse events due to any cause, whether related or unrelated to treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Treatment', 'description': 'Participants ingested placebo tablets 6 times daily (with meals and 3 snacks) for 10 days. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PES Treatment', 'description': 'Participants ingested PES tablets 6 times daily (with meals and 3 snacks) for 10 days. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Gastrointestinal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Treatment', 'description': 'Participants ingested placebo tablets 6 times daily (with meals and 3 snacks) for 10 days. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered'}, {'id': 'OG001', 'title': 'PES Treatment', 'description': 'PES treatment was taken 6 times daily with gluten-free meals and 3 snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered.'}, {'id': 'OG002', 'title': 'Within Participant Difference in Scores Between Treatment Periods', 'description': 'We calculated a delta change between the GSRS scores at end of Placebo treatment and end of PES treatment'}], 'classes': [{'title': 'GSRS score', 'categories': [{'measurements': [{'value': '35.75', 'spread': '12.11', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '13.38', 'groupId': 'OG001'}, {'value': '-1.75', 'spread': '5.83', 'groupId': 'OG002'}]}]}, {'title': 'GSRS score: Abdominal pain', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.79', 'groupId': 'OG002'}]}]}, {'title': 'GSRS score: Diarrhea score', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '0.65', 'groupId': 'OG002'}]}]}, {'title': 'GSRS score: Indigestion score', 'categories': [{'measurements': [{'value': '2.45', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.07', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '2.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.271', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at end of each 10- day treatment period', 'description': 'The average per individual subject on-treatment score in the Celiac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS) domains of Diarrhea, Indigestion, and Abdominal pain comparing active treatment to placebo (i.e. a paired comparison of CeD GSRS on treatment versus on placebo for each subject).\n\nCeD-GSRS: Each individual sub-section of the 15 sub-sections scores from 1 to 7, with greater scores indicating worse symptoms. A total score can range from 15 -105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed entire study duration were included in the analysis. A comparison of the within-pair differences (delta) in symptom scores after Pancreatic Enzyme Supplement and Placebo treatment, by the Wilcoxon signed rank test.'}, {'type': 'SECONDARY', 'title': 'Correlation of Baseline Fecal Elastase and Celiac Disease Gastrointestinal Symptom Response at End of PES Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Participants', 'description': 'Correlation between Baseline fecal elastase measurement and Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores at the end of PES treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.223', 'groupId': 'OG000', 'lowerLimit': '-0.198', 'upperLimit': '0.646'}]}]}], 'analyses': [{'pValue': '0.995', 'groupIds': ['OG000'], 'statisticalMethod': 'Spearman rank coefficient', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "In order to calculate a correlation between baseline fecal elastase-1 and total CeD-GSRS score on PES treatment vs. placebo treatment, we calculated a Spearman's rank correlation coefficient between the two independent variables."}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline visit (fecal elastase levels measured) and end of PES treatment period (CeD-GSRS scores measured)', 'description': 'Baseline fecal elastase measurement will be correlated with Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores at the end of PES treatment period.\n\nCeliac Disease Gastrointestinal Symptom Response Scale:scores range from 1 to 7, with greater scores indicating worse symptoms. The minimum score obtainable is 15 and the maximum score obtainable is 105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.', 'unitOfMeasure': 'Correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "At the baseline visit, all subjects had their fecal elastase measured from a baseline stool sample. This fecal elastase level was then correlated at the end of the study with a participant's response to treatment. PES treatment response was measured by GSRS scores at the end of PES treatment period."}, {'type': 'SECONDARY', 'title': 'Change in Celiac Symptom Index Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Treatment', 'description': 'Evaluated CSI score across all participants during the Placebo treatment'}, {'id': 'OG001', 'title': 'PES Treatment', 'description': 'Evaluated CSI score across all participants during the PES treatment'}, {'id': 'OG002', 'title': 'Within Participant Difference in Scores Between Treatment Periods', 'description': 'We calculated a delta change between the CSI scores at the end of Placebo treatment and end of PES treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.75', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '35.92', 'spread': '9.55', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '4.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000'], 'statisticalMethod': 'Linear Mixed Effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'In order to evaluate the estimated difference of the effect of Pancreatic Enzyme Supplement versus Placebo for the Celiac Symptom Index (CSI) scores, we used a linear mixed effects model with the nlme package.'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the end of each 10-day treatment period', 'description': 'The average per individual subject on-treatment scores in the Celiac Symptom Index (CSI) comparing PES treatment to placebo.\n\nFor the Celiac Symptom Index: scores range from 16 to 80, with greater scores indicating worse symptoms\n\nLeffler DA, Dennis M, Edwards George J, Jamma S, Cook EF, Schuppan D, Kelly CP. A validated disease-specific symptom index for adults with celiac disease. Clin Gastroenterol Hepatol. 2009;7:1328-34. PubMed PMID: 19665584.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PES, Then Placebo', 'description': 'Participants first received Pancreatic Enzyme Supplementation (PES) for 10 days. PES taken 6 times daily with gluten free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received placebo tablets (matching PES treatment) 6 times daily for 10 days.'}, {'id': 'FG001', 'title': 'Placebo, Then PES', 'description': 'Participants first received placebo tablets (matching PES) for 10 days. Placebo was taken 6 times daily with gluten-free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received PES tablets six times daily for 10 days.'}], 'periods': [{'title': 'Run-in Washout Period #1 (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Sponsor terminated study prematurely', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Treatment Period #1 (10 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Run-in Washout Period #2 (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period #2 (10 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were screened for eligibility between 4/16/2015 and 5/28/2017 at Beth Israel Deaconess Medical Center in Boston Massachusetts', 'preAssignmentDetails': '21 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Treatments', 'description': 'The treatment phase was comprised of two 10-day treatment periods. The study began with a 7 day washout period followed by Treatment period 1. After 10 day treatment period one all participants received a 7 day washout run-in period. Finally, all patients received a 10 day treatment period 2. Participants were randomized to two groups which were "PES, then Placebo" (n=3) or "Placebo, then PES" (n=9). Per cross-over design, all subjects have received both intervention at the end of the trial.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Celiac Disease Gastrointestinal Symptom (CeD-GSRS)Response Scale', 'classes': [{'categories': [{'measurements': [{'value': '3.25', 'groupId': 'BG000', 'lowerLimit': '2.30', 'upperLimit': '4.30'}]}]}], 'paramType': 'MEDIAN', 'description': 'Celiac Disease Gastrointestinal Symptom Response Scale:scores range from 1 to 7, with greater scores indicating worse symptoms. The minimum score obtainable is 15 and the maximum score obtainable is 105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline Celiac Symptom Index (CSI)', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'description': 'Celiac Symptom Index: scores range from 16 to 80, with greater scores indicating worse symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline abdominal pain on Celiac Disease Gastrointestinal Symptom Response Scale (CeD-GSRS)', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Celiac Disease Gastrointestinal Symptom Response Scale:scores range from 1 to 7, with greater scores indicating worse symptoms. On the domain of abdominal pain the minimum score is 1 and the maximum is 7. The higher the overall score, the more severe the symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline Celiac Disease Adherence Test', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'description': 'Celiac Dietary Adherence Test:scores range from 5 to 35, with greater scores indicating poorer adherence;', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline IgA anti-human tissue transglutaminase assay (tTG-IgA)', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'description': 'IgA anti-human tissue transglutaminase assay (Inova Diagnostics, Inc., San Diego, USA): negative \\<20, borderline 20-30, positive \\>30;', 'unitOfMeasure': 'unit/liter', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline Fecal elastase-1 levels', 'classes': [{'categories': [{'title': '<200 µg/g', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '200-500 µg/g', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>500 µg/g', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Normal range of fecal elastase-1 (Joli Diagnostics, Inc., Buffalo, USA): 200-500 µg/g stool,\\<200 µg/g stool indicates positive fecal elastase-1 test.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-08', 'size': 1067001, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-16T14:49', 'hasProtocol': True}, {'date': '2017-10-18', 'size': 745603, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-17T10:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'The trial was terminated prematurely by the sponsor for administrative reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2015-06-16', 'resultsFirstSubmitDate': '2020-05-30', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-19', 'studyFirstPostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Gastrointestinal Symptoms', 'timeFrame': 'Measured at end of each 10- day treatment period', 'description': 'The average per individual subject on-treatment score in the Celiac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS) domains of Diarrhea, Indigestion, and Abdominal pain comparing active treatment to placebo (i.e. a paired comparison of CeD GSRS on treatment versus on placebo for each subject).\n\nCeD-GSRS: Each individual sub-section of the 15 sub-sections scores from 1 to 7, with greater scores indicating worse symptoms. A total score can range from 15 -105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.'}], 'secondaryOutcomes': [{'measure': 'Correlation of Baseline Fecal Elastase and Celiac Disease Gastrointestinal Symptom Response at End of PES Treatment', 'timeFrame': 'Baseline visit (fecal elastase levels measured) and end of PES treatment period (CeD-GSRS scores measured)', 'description': 'Baseline fecal elastase measurement will be correlated with Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores at the end of PES treatment period.\n\nCeliac Disease Gastrointestinal Symptom Response Scale:scores range from 1 to 7, with greater scores indicating worse symptoms. The minimum score obtainable is 15 and the maximum score obtainable is 105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.'}, {'measure': 'Change in Celiac Symptom Index Scores', 'timeFrame': 'Measured at the end of each 10-day treatment period', 'description': 'The average per individual subject on-treatment scores in the Celiac Symptom Index (CSI) comparing PES treatment to placebo.\n\nFor the Celiac Symptom Index: scores range from 16 to 80, with greater scores indicating worse symptoms\n\nLeffler DA, Dennis M, Edwards George J, Jamma S, Cook EF, Schuppan D, Kelly CP. A validated disease-specific symptom index for adults with celiac disease. Clin Gastroenterol Hepatol. 2009;7:1328-34. PubMed PMID: 19665584.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pancreatic enzyme supplementation'], 'conditions': ['Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '23163616', 'type': 'BACKGROUND', 'citation': 'Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.'}, {'pmid': '3123181', 'type': 'BACKGROUND', 'citation': 'Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.'}, {'pmid': '36687454', 'type': 'DERIVED', 'citation': 'Yoosuf S, Barrett CG, Papamichael K, Madoff SE, Kurada S, Hansen J, Silvester JA, Therrien A, Singh P, Dennis M, Leffler DA, Kelly CP. Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial. Front Med (Lausanne). 2023 Jan 4;9:1001879. doi: 10.3389/fmed.2022.1001879. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to:\n\n1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet.\n2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Biopsy proven celiac disease.\n* Age 18-80.\n* Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in period.\n* Subject must be following a gluten free diet.\n* tTG \\< 40 units at screening.\n\nExclusion Criteria:\n\n* Taking prescription or over the counter enzyme supplements for 1 month prior to enrollment.\n* Pregnant, breastfeeding or planning pregnancy. Woman using acceptable methods of contraception will be included. Acceptable methods of contraception include oral hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide, condoms, intra-uterine device, abstinence, and male partner vasectomy.\n* Patients with a pork allergy or who are unwilling to consume pork products.\n* English proficiency unsuitable for completion of surveys.\n* Known severe pancreatic disease.\n* Known history of prior cancer (except squamous or basal cell skin cancer).\n* Patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2 tablespoons) of whole milk per day.\n* Clinically significant abnormality in safety lab values (i.e. CBC and BMP) at screening that may impact subject safety or the scientific integrity of the study.\n* Other known active GI condition including but not limited to inflammatory bowel disease, small intestine bacterial overgrowth, and obvious FODMAP intolerance.\n* History of all major gastrointestinal surgery other than appendectomy or cholecystectomy.\n* Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study."}, 'identificationModule': {'nctId': 'NCT02475369', 'briefTitle': 'Pancreatic Enzyme Supplementation for Celiac Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Pilot Study of the Efficacy of Pancreatic Enzyme Supplementation for Symptom Control in Celiac Disease Not Responding to the Gluten Free Diet', 'orgStudyIdInfo': {'id': '2014P000375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PES, Then Placebo', 'description': 'Participants first received Pancreatic Enzyme Supplementation (PES) for 10 days. PES taken 6 times daily with gluten free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received placebo tablets (matching PES treatment) 6 times daily for 10 days.', 'interventionNames': ['Drug: pancrelipase']}, {'type': 'OTHER', 'label': 'Placebo, Then PES', 'description': 'Participants first received placebo tablets (matching PES) for 10 days. Placebo was taken 6 times daily with gluten-free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received PES tablets six times daily for 10 days.', 'interventionNames': ['Drug: pancrelipase']}], 'interventions': [{'name': 'pancrelipase', 'type': 'DRUG', 'otherNames': ['Viokase', 'lipase, protease, amylase'], 'armGroupLabels': ['PES, Then Placebo', 'Placebo, Then PES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ciaran Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Actavis Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Ciaran Kelly', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}