Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:05 PM
Study NCT ID:
NCT07439718
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009821', 'term': 'Oils'}], 'ancestors': [{'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total bacterial abundance of the gut microbiota captured in small intestinal fluid after one-month intervention with a butyric acid-rich triglyceride oil', 'timeFrame': 'From Baseline (Day 1) through study completion (average duration: 36 days)', 'description': 'We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)'}, {'measure': 'Change in total bacterial abundance of the gut microbiota captured in fecal samples after one-month intervention with a butyric acid-rich triglyceride oil', 'timeFrame': 'From Baseline (Day 1) through study completion (average duration: 36 days)', 'description': 'We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)'}], 'secondaryOutcomes': [{'measure': 'Change in butyrate levels in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.', 'timeFrame': 'From Baseline (Day 1) to Day 8 (after first ingestion of IP)', 'description': 'To assess the release of butyrate in the small intestine after acute ingestion of the butyric acid-rich triglyceride oil.'}, {'measure': 'Change in absolute amount of various lipid classes (e.g. triglycerides, fatty acids, etc.) in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.', 'timeFrame': 'From Baseline (Day 1) to Day 8 (after first ingestion of IP)', 'description': 'To assess the change in lipids metabolism in the small intestine after acute ingestion of the butyric acid-rich triglyceride oil.'}, {'measure': 'Change in butyrate levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.', 'timeFrame': 'Day 8 (before and after ingestion of IP)', 'description': 'To assess the release of butyrate in the small intestine measured through the absorption in the bloodstream after acute ingestion of the butyric acid-rich triglyceride oil.'}, {'measure': 'Change in ketone bodies levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.', 'timeFrame': 'Day 8 (before and after ingestion of IP)', 'description': 'To assess the release of ketone bodies in the small intestine measured through the absorption in the bloodstream after acute ingestion of the butyric acid-rich triglyceride oil.'}, {'measure': 'Change in total bacterial abundance of the microbiota of saliva after one-month intervention with butyric acid-rich triglyceride oil.', 'timeFrame': 'From Baseline (Day 1) through study completion (average duration: 36 days)', 'description': 'To identify changes in the oral microbiome composition after one-month intervention with butyric acid-rich triglyceride oil.'}, {'measure': 'Change in total GSRS scores after one-month intervention with butyric acid-rich triglyceride oil', 'timeFrame': 'From Baseline (Day 1) through study completion (average duration: 36 days)', 'description': 'To assess the tolerability of butyric acid-rich triglyceride oil intake.'}, {'measure': 'Change in GSRS scores in each of the 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation) after one-month intervention with butyric acid-rich triglyceride oil', 'timeFrame': 'From Baseline (Day 1) through study completion (average duration: 36 days)', 'description': 'To assess the tolerability of butyric acid-rich triglyceride oil intake.'}, {'measure': 'Change in the Bristol stool scale after one-month intervention with butyric acid-rich triglyceride oil', 'timeFrame': 'From Baseline (Day 1) through study completion (average duration: 36 days)', 'description': 'To assess the tolerability of butyric acid-rich triglyceride oil intake.'}, {'measure': 'Ease of retrieval of capsules based on participant feedback', 'timeFrame': 'From Baseline (Day 1) through study completion (average duration: 36 days)', 'description': 'Participants will be asked to provide feedback on the ease of retreival of capsule through a simple questionnaire, and this will be used to assess the feasibility of incorporating the use of the SIMBA capsule in clinical trials.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microbiome Composition', 'Microbiome']}, 'descriptionModule': {'briefSummary': 'This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females aged 18 to 60 years, inclusive, at enrollment.\n2. BMI of ≥18.5 but \\<30 kg/m2.\n3. Healthy, as determined based on self-reported medical history.\n4. No planned change in diet or medical interventions during the study.\n5. Willing to collect fecal samples and retrieve sampling capsules from feces.\n6. Able to understand and to sign a written informed consent prior to study enrollment.\n7. Willing and able to comply with the requirements for participation in this study.\n\nExclusion Criteria:\n\n1. Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).\n2. Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.\n3. History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.\n4. History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.\n5. Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.\n6. Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.\n7. Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.\n8. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.\n9. Any concurrent cancer diagnosis, as reported by the participant.\n10. Any cancer treatment within the past year, as reported by the participant.\n11. History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.\n12. Any cardiovascular, endocrine, renal, liver, or other chronic disease likely to affect motility (i.e. diabetes mellitus, concurrent biliary tract stones, kidney stones, etc.), as reported by the participant.\n13. Antibacterial/antifungal therapy in the past 3 months prior to enrolment, as reported by the participant.\n14. Use of any medications or supplements that could substantially alter gastrointestinal acidity, motor function, or microbiota (e.g. proton pump inhibitors, H2 receptor antagonists, opioids, prokinetics, anticholinergics, laxatives) in the past 4 weeks prior to enrollment, as reported by the participant.\n15. Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.\n16. Scheduled for an MRI at any time during the study duration. Potential participants may be eligible to participate once their MRI procedure is completed.\n17. Females of childbearing age who are pregnant or lactating, as reported by the participant (should an X-ray be required for confirmation of capsule passage; a urine pregnancy test will be administered beforehand).\n18. Alcohol intake higher than 2 servings per day over a week (for males), or more than 1 serving per day over a week (for females), as reported by the participant. A serving is 0.3 dl of strong alcohol, 1 dl of wine, or 3 dl of beer.\n19. Currently participating in another interventional study.\n20. Family or hierarchical relationships with the research team members."}, 'identificationModule': {'nctId': 'NCT07439718', 'briefTitle': 'The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome', 'orgStudyIdInfo': {'id': '2504CLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Product Arm - butyric acid-rich triglyceride oil', 'description': 'Butyric acid-rich triglyceride oil, commercially available', 'interventionNames': ['Dietary Supplement: Oil']}], 'interventions': [{'name': 'Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The investigational product will be taken orally (10mL) once a day for the duration of 28 days (up to a maximum of 37 days).', 'armGroupLabels': ['Interventional Product Arm - butyric acid-rich triglyceride oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ambra Giorgetti', 'role': 'CONTACT', 'email': 'ambra.giorgetti@rd.nestle.com', 'phone': '+41763163505'}, {'name': 'Carolina Stambolsky, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ambra Giorgetti, PhD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Lab', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Marie-Pierre Pélissou', 'role': 'CONTACT', 'email': 'marie-pierre.pelissou@rd.nestle.com', 'phone': '+41 21 785 86 39'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}