NCT04542018CompletedNot Applicable
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 48
- Locations
- 4
- Primary Endpoint
- Lactulose Mannitol Excretion
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Lactulose Mannitol Excretion
Time Frame: 4 weeks
Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h
Secondary Outcomes
- Changes in Stool Microbiome - Alpha Diversity(4 weeks)
- Immunohistochemistry for Mast Cells(4 weeks)
- Changes in Epithelial Permeability - Tight Junction Gene Expression(4 weeks)
- Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining(4 weeks)
- Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)(4 weeks)
- Changes in Stool Microbiome - Beta Diversity(4 weeks)
Investigators
Prashant Singh
Assistant Professor
University of Michigan
Study Sites (4)
Loading locations...
Similar Trials
Completed
Not Applicable
The Impact of Dietary Treatment in Patients With Irritable Bowel SyndromeIrritable Bowel SyndromeNCT04307368Medical University of Bialystok73
Completed
Not Applicable
The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related SymptomsFODMAP DietFunctional DyspepsiaNCT06388330Universitaire Ziekenhuizen KU Leuven32
Recruiting
Not Applicable
Low FODMAP Diet in FD (PDS)Functional Gastrointestinal DisordersNCT05832528Universitaire Ziekenhuizen KU Leuven30
Completed
Not Applicable
Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.Functional Abdominal Pain SyndromeNCT03771027University of Warmia and Mazury33
Completed
Not Applicable
Low FODMAPs Diet in Gastrointestinal DisordersInflammatory Bowel DiseasesCoeliac DiseaseIrritable Bowel SyndromeNCT03644602Federico II University150