N/A
N=48
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04542018 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Lactulose Mannitol Excretion — 512.5; 394.5; 456.8; 411 micrograms per ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- a low FODMAP diet for 4 weeks (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lactulose Mannitol Excretion |
512.5; 394.5; 456.8; 411; 41395; 86820 | — |
| SECONDARY Changes in Epithelial Permeability - Tight Junction Gene Expression |
.9; .7; 1.4; 1.1; 0.9; 0.5 | — |
| SECONDARY Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining |
0.06579; 0.03703; 0.07330; 0.05063; 0.07493; 0.08437 | — |
| SECONDARY Changes in Stool Microbiome - Alpha Diversity |
649.087; 532.75; 599.7391; 608.5 | — |
| SECONDARY Changes in Stool Microbiome - Beta Diversity |
-0.03722; -0.2708 | — |
| SECONDARY Immunohistochemistry for Mast Cells |
23; 26.5; 14.5; 11.5 | — |
| SECONDARY Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) |
63.6; 64.1; 63.7; 47.1; 60.8; 61.2 | — |
Summary
This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms.
Eligibility Criteria
Inclusion Criteria
- Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms.
- Normal stool studies including, ova and parasites since the onset of symptoms
- IBS-SSS score of ≥175 at the end of the 7-day screening period
In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.
Exclusion criteria
- individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
- individuals with any known food allergy or insulin-dependent diabetes
- known history of celiac disease, inflammatory bowel disease or microscopic colitis
- prior small bowel or colonic surgery or cholecystectomy
- pregnant patients
- Antibiotics in the past 3 months
- Those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
Data sourced from ClinicalTrials.gov (NCT04542018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.