Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-20 @ 6:06 PM
Study NCT ID:
NCT05417958
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper GI symptoms', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'differences in daily parental rating of upper gastrointestinal symptoms from the validated Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) between extremely and mildly thick blenderized tube feeds'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal symptoms', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden'}, {'measure': 'Gastrointestinal symptoms', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden'}, {'measure': 'Pulmonary symptoms', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden'}, {'measure': 'Health care utilization', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'frequency of hospital admissions'}, {'measure': 'Health care utilization', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'length of hospital admissions'}, {'measure': 'Health care utilization', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'rates of ER/urgent care visits'}, {'measure': 'GI medication use', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': '% of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin'}, {'measure': 'Height', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'height'}, {'measure': 'Weight', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'Weight or weight for length'}, {'measure': 'Weight for height/body mass index (BMI)', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'weight for height (children \\< 2) or BMI (over 2 years of age)'}, {'measure': 'number of patients with unplanned G-tube exchange', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)'}, {'measure': 'urine output adequacy', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'frequency of urine output'}, {'measure': 'rate of respiratory suctioning per day', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'how often suctioning is required (e.g. number of times per day)'}, {'measure': 'need for antibiotics for pneumonitis', 'timeFrame': '8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)', 'description': 'frequency of antibiotics prescribed for pulmonary indications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feeding Disorders']}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\> 1 year\n* \\>90% of total calories via G-tube for \\> 6 months\n* G-tube diameter ≥ 14 French\n* moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score \\> 2\n* anticipated stable GI-related medications for the duration of the study.\n\nExclusion Criteria:\n\n* cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant\n* untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)\n* Nissen fundoplication\n* use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases\n* allergy or intolerance to any component of the study diet\n* inability to tolerate bolus gastric feeds."}, 'identificationModule': {'nctId': 'NCT05417958', 'briefTitle': 'Clinical Trial of Blenderized Tube Feeds Varying in Viscosity', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology', 'orgStudyIdInfo': {'id': 'IRB-P00042262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick', 'description': 'Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.', 'interventionNames': ['Other: Extremely thick blenderized tube feed', 'Other: Mildly thick blenderized tube feed']}, {'type': 'EXPERIMENTAL', 'label': 'Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick', 'description': 'Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.', 'interventionNames': ['Other: Extremely thick blenderized tube feed', 'Other: Mildly thick blenderized tube feed']}, {'type': 'EXPERIMENTAL', 'label': 'Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick', 'description': 'Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.', 'interventionNames': ['Other: Extremely thick blenderized tube feed', 'Other: Mildly thick blenderized tube feed']}, {'type': 'EXPERIMENTAL', 'label': 'Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick', 'description': 'Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.', 'interventionNames': ['Other: Extremely thick blenderized tube feed', 'Other: Mildly thick blenderized tube feed']}], 'interventions': [{'name': 'Extremely thick blenderized tube feed', 'type': 'OTHER', 'description': 'Commercial blenderized tube feed, not diluted', 'armGroupLabels': ['Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick', 'Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick', 'Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick', 'Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick']}, {'name': 'Mildly thick blenderized tube feed', 'type': 'OTHER', 'description': 'Commercial blenderized tube feed, diluted with ingredients contained in blend', 'armGroupLabels': ['Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick', 'Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick', 'Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick', 'Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bridget M Hron, MD', 'role': 'CONTACT', 'email': 'bridget.hron@childrens.harvard.edu', 'phone': '6173551433'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'Bridget Hron', 'investigatorAffiliation': "Boston Children's Hospital"}}}}