Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:36 AM
Study NCT ID:
NCT07303868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-03-29', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric bile acid concentration', 'timeFrame': 'after 2 weeks on each of 2 diets (cross-over design)', 'description': 'differences in total gastric bile acid concentrations at the end of each diet period'}], 'secondaryOutcomes': [{'measure': 'Gastric bile acid concentration', 'timeFrame': 'after 2 weeks on each of 2 diets (cross-over design)', 'description': 'changes in gastric bile acid composition (e.g., change in the proportion of gastric conjugated:unconjugated bile acid) between diet periods'}, {'measure': 'Symptom scores', 'timeFrame': 'after 2 weeks on each of 2 diets (cross-over design)', 'description': 'changes in symptoms over the two weeks between diet periods'}, {'measure': 'Salivary and stool bile acid concentrations', 'timeFrame': 'after 2 weeks on each of 2 diets (cross-over design)', 'description': 'changes in the total salivary and stool BA concentrations between diet periods;'}, {'measure': 'Serum complement 4 (C4)', 'timeFrame': 'after 2 weeks on each of 2 diets (cross-over design)', 'description': 'changes in serum C4 between diet periods'}, {'measure': 'gastric, salivary, and stool bile acid', 'timeFrame': 'after 2 weeks on each of 2 diets (cross-over design)', 'description': 'changes in gastric, salivary, and stool bile acid over time between the high bile binding blend, low bile binding blend and amino acid-based formula groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blenderized', 'bile acid', 'gastrostomy', 'aspiration'], 'conditions': ['Feeding Difficulties', 'Gastrostomy', 'Aspiration']}, 'descriptionModule': {'briefSummary': 'Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria\n\n* receive at least 80% of their nutritional needs via gastrostomy\n* receive blenderized feeds or will start receiving blenderized feeds\n* have no known allergies to ingredients in blenderized feeds;\n* receive their bolus feeds within 30 minutes or less\n* can receive their feeds by syringe push Exclusion criteria\n* have undergone anti-reflux surgery\n* receive post-pyloric feeds\n* are allergic to any component of the administered diets\n* cannot receive their gastrostomy feeds over 30 minutes\n* require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).\n\nPediatric patients ages 5 to 21 in the observational arm Inclusion\n\n* receive at least 80% of their nutritional needs via gastrostomy\n* are taking an amino acid formula\n* have not undergone antireflux surgery Exclusion\n* have undergone anti-reflux surgery\n* receive post-pyloric feeds\n* are not receiving an amino acid-based formula.'}, 'identificationModule': {'nctId': 'NCT07303868', 'briefTitle': 'The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations: A Novel Intervention for Children at Risk for Aspiration-Associated Complications (Aim 2)', 'orgStudyIdInfo': {'id': 'IRB-P00049734 Aim 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low bile binding then high bile binding blenderized diets', 'description': '2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets', 'interventionNames': ['Drug: Low bile acid binding blenderized diet', 'Drug: High bile acid binding blenderized diet']}, {'type': 'EXPERIMENTAL', 'label': 'High bile binding then low bile binding blenderized diets', 'description': '2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets', 'interventionNames': ['Drug: Low bile acid binding blenderized diet', 'Drug: High bile acid binding blenderized diet']}, {'type': 'NO_INTERVENTION', 'label': 'amino acid-based formula', 'description': 'Observational arm'}], 'interventions': [{'name': 'Low bile acid binding blenderized diet', 'type': 'DRUG', 'description': 'Low bile acid binding blenderized diet administered for 2 weeks', 'armGroupLabels': ['High bile binding then low bile binding blenderized diets', 'Low bile binding then high bile binding blenderized diets']}, {'name': 'High bile acid binding blenderized diet', 'type': 'DRUG', 'description': 'High bile acid binding blenderized diet administered for 2 weeks', 'armGroupLabels': ['High bile binding then low bile binding blenderized diets', 'Low bile binding then high bile binding blenderized diets']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Aerodigestive Center', 'investigatorFullName': 'Rachel Rosen', 'investigatorAffiliation': "Boston Children's Hospital"}}}}