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Effect of a Low FODMAP Diet on SIBO

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Invitation-only

Conditions

SIBO

Treatments

Other: low FODMAP diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04627727
2020P000622

Details and patient eligibility

About

Bloating is the most common symptom associated with disorders of brain-gut interaction (i.e., functional bowel disorders) such as irritable bowel syndrome, a disorder characterized by abdominal pain and altered bowel habits which affects up to 11% of world population. A common cause of bloating is small intestinal bacterial overgrowth (SIBO), a condition defined by excessive and/or abnormal type of bacteria in the small bowel. The potential role of SIBO for irritable bowel syndrome (IBS) was initially proposed by Pimentel et al. Using lactulose breath tests (LBTs), 78% of patients with IBS were also diagnosed with SIBO. After antibiotic therapy, 48% of patients no longer met the Rome criteria for IBS. A recent systematic review and meta-analysis concluded that the prevalence of SIBO is increased in IBS.

Despite the clinical efficacy of LFD in improving symptoms of IBS-D, its mechanism of action is not clear. Recently, Zhou et al have shown FODMAPs induce colonic tight junction dysfunction and visceral hypersensitivity in rat models, both of which are reversible when rats were fed an LFD. They further showed that this effect of FODMAPs is mediated by microbial dysbiosis and elevated fecal lipopolysaccharide level. However, studies evaluating the effect of LFD on colonic permeability of humans are lacking. Studies have shown significant differences in intra-individual luminal and mucosal microbiome of patients with functional gastrointestinal disorders as well as an increase in Prevotella abundance in IBS patients with SIBO as compared with IBS patients without SIBO. Thus, the exact effect of FODMAP on intestinal permeability and mucosal microbiome in humans is not clear and needs further evaluation.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged 18-65 years at the time of screening
  • Meet Rome IV criteria for functional bloating
  • IBS-SSS score of at 176 (0-500)
  • SIBO positive

Exclusion criteria

  • individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
  • individuals with peanut, soy, or seafood allergies 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, excluding topical, in the past 3 months

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

low FODMAP diet
Experimental group
Treatment:
Other: low FODMAP diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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