Effect of a Low FODMAP Diet on SIBO

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04627727
Collaborator
(none)
30
1
1
11.7
2.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: low FODMAP diet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of a Low FODMAP Diet on SIBO
Actual Study Start Date :
Nov 12, 2020
Anticipated Primary Completion Date :
Nov 2, 2021
Anticipated Study Completion Date :
Nov 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: low FODMAP diet

Other: low FODMAP diet
low FODMAP diet

Outcome Measures

Primary Outcome Measures

  1. SIBO diagnosis [three weeks]

    presence or absence of SIBO

Secondary Outcome Measures

  1. Rome IV Functional Bloating diagnostic criteria [3 weeks]

    Rome IV Functional Bloating

  2. IBS-SSS [3 weeks]

    change in IBS-SSS from baseline to final

Other Outcome Measures

  1. serum LPS level [3 weeks]

    change in serum LPS concentration from baseline to final

  2. serum zonulin level [3 weeks]

    change in serum zonulin concentration from baseline to final

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anthony Lembo, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT04627727
Other Study ID Numbers:
  • 2020P000622
First Posted:
Nov 13, 2020
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 13, 2020