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A Clinical Trial Evaluating Diets for IBS

NCT ID: NCT05831306

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Keywords

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dietary intervention lifestyle intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Diet A

Modified Diet A

Group Type EXPERIMENTAL

Diet A

Intervention Type OTHER

Modified Diet A

Diet B

Modified Diet B

Group Type EXPERIMENTAL

Diet B

Intervention Type OTHER

Modified Diet B

Interventions

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Diet A

Modified Diet A

Intervention Type OTHER

Diet B

Modified Diet B

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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)
2. Aged 18-65 years at the time of screening
3. Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0- to-10 point scale
4. At least 80% compliance in daily diary entries during the 7-day screening period

Exclusion Criteria

1. 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
2. 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).
3. Subjects with a history of insulin-dependent or non-insulin-dependent diabetes
4. Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
5. Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
6. BMI \< 18.5
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan - Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Johanna Iturrino Moreda, MD

Role: CONTACT

Phone: 6176672138

Email: [email protected]

Facility Contacts

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Samantha Proctor

Role: primary

Prashant Singh, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38729393 (View on PubMed)

Other Identifiers

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2020P000625

Identifier Type: -

Identifier Source: org_study_id