Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bow… (NCT04542018) | Clinical Trial Compass
CompletedNot Applicable
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
United States48 participantsStarted 2020-08-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.