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NCT04526808
Effects of Low FODMAP Diet on Leaky Gut
NA trial testing FODMAP diet in Irritable Bowel Syndrome in 14 participants. Completed in 1 June 2021.
1 June 2021
Quick facts
| Lead sponsor | Beth Israel Deaconess Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 14 |
| Start date | 20 May 2019 |
| Primary completion | 1 June 2021 |
| Estimated completion | 1 June 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- FODMAP diet
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
Sponsor
Beth Israel Deaconess Medical Center
Who can join
Adults 18 to 65, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04526808
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of FODMAP diet
Trials testing the same drug.
- NCT03460613 — Prevalence of FODMAP Intolerance and JHS in FGID and Association With Microbiome, Dyssynergic Defecation and Dietary Int · NA · completed
Other recruiting trials for Irritable Bowel Syndrome
Currently open trials in the same condition.
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- NCT07360938 — Drug Interaction Potential of Pro-Inflammatory Conditions · recruiting
- NCT06788444 — Efficacy of Esketamine for Patients With Irritable Bowel Syndrome · NA · recruiting
- NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting
Other Beth Israel Deaconess Medical Center trials
Trials by the same sponsor.
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- NCT07534683 — Primed to Thrive: Investigating the Combined Impact of Mindfulness Education and Meditation Practice on Psychological an · NA · not yet recruiting
- NCT07277244 — Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study · NA · enrolling by invitation
- NCT06896474 — SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04526808 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beth Israel Deaconess Medical Center
- Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04526808.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing