Recruiting

Diets for IBS

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05831306

Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Diet A

Diet B

Study Details

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.

Conditions

Irritable Bowel Syndrome

Study ID

NCT05831306

Start date

Jul 21, 2021

Status verified date

Apr, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diet A

Modified Diet A

experimental: Diet B

Modified Diet B

Interventions

Diet A

Modified Diet A

Diet B

Modified Diet B

Primary outcome measure

  • Abdominal Pain Intensity [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Johanna Iturrino Moreda, MD

6176672138jiturrin@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Samantha Proctor

sprocto1@bidmc.harvard.edu

University of Michigan - Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Prashant Singh, MD

singhpr@med.umich.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 28, 2023

Last verified

Apr, 2023

Keywords

  • dietary intervention
  • lifestyle intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2023-04-28.