NCT05831306

Brief Summary

Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

April 14, 2023

Last Update Submit

April 27, 2023

Conditions

Irritable Bowel Syndrome

Keywords

dietary interventionlifestyle intervention

Outcome Measures

Primary Outcomes (1)

  • Abdominal Pain Intensity

    Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.

    28 days

Secondary Outcomes (7)

  • Abdominal Discomfort Intensity

    28 days

  • Composite Score

    28 days

  • Abdominal Bloating Intensity

    28 days

  • Stool Consistency

    28 days

  • Irritable Bowel Syndrome - Symptom Severity Score

    28 days

  • +2 more secondary outcomes

Study Arms (2)

Diet A

EXPERIMENTAL

Modified Diet A

Other: Diet A

Diet B

EXPERIMENTAL

Modified Diet B

Other: Diet B

Interventions

Diet AOTHER

Modified Diet A

Diet A
Diet BOTHER

Modified Diet B

Diet B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with IBS-D diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, family history of inflammatory bowel disease or celiac disease)
  • Aged 18-65 years at the time of screening
  • Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0- to-10 point scale
  • At least 80% compliance in daily diary entries during the 7-day screening period

You may not qualify if:

  • Subjects adhering to a dietary IBS-treatments such as the low-fat diet, low FODMAP diet, or gluten-free diet within the past 6 months
  • Subjects with a known food allergy to eggs, peanuts, or milk (subjects with lactose intolerance who are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
  • Subjects with a history of insulin-dependent or non-insulin-dependent diabetes
  • Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
  • Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
  • BMI \< 18.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan - Ann Arbor

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (1)

  • Singh P, Chey SW, Nee J, Eswaran S; Dietary Therapy in IBS Working Group; Lembo A, Chey WD. Is a Simplified, Less Restrictive Low FODMAP Diet Possible? Results From a Double-Blind, Pilot Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Feb;23(2):362-364.e2. doi: 10.1016/j.cgh.2024.04.021. Epub 2024 May 9.

    PMID: 38729393DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Johanna Iturrino Moreda, MD

CONTACT

6176672138jiturrin@bidmc.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 26, 2023

Study Start

July 21, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)