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ClinicalTrials.gov Identifier: NCT04526808
Recruitment Status : Unknown
Verified August 2020 by Anthony Lembo, Beth Israel Deaconess Medical Center. Recruitment status was: Recruiting
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
aged 18-65 years at the time of screening
normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
IBS-SSS score of ≥175 at the end of 7-day screening period
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
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.