A Clinical Trial Evaluating Diets for IBS

A Randomized Clinical Trial Evaluating Two Different Diets for IBS

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Diet A; Other: Diet B

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna Iturrino Moreda, MD; Phone Number: 6176672138; Email: jiturrin@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Samantha Proctor; Email: sprocto1@bidmc.harvard.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan - Ann Arbor
      • Contact: Prashant Singh, MD; Email: singhpr@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet A; Modified Diet A	Other: Diet A; Modified Diet A
Experimental: Diet B; Modified Diet B	Other: Diet B; Modified Diet B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Discomfort Intensity	Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal discomfort in the past 24 hours score of at least 30% compared with baseline.	28 days
Composite Score	Proportion of weekly composite responders. A weekly composite responder is defined as a subject who experiences a decrease in the weekly average of worst abdominal pain in the 24 hours score of at least 30% compared with baseline AND who experiences a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline	28 days
Abdominal Bloating Intensity	Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal bloating in the past 24 hours score of at least 30% compared with baseline.	28 days
Stool Consistency	Weekly responder. A weekly responder is defined as a decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Bristol Stool Form Scale Type 6 or Type 7 compared with baseline.	28 days
Irritable Bowel Syndrome - Symptom Severity Score	Proportion of subjects who experience a 50-point and 100-point decrease in IBS-SSS compared with baseline.	28 days
Irritable Bowel Syndrome - Symptom Severity Score	Change in IBS-SSS as compared with baseline.	28 days
Adequate Relief	Proportion of subjects who experience adequate relief compared with baseline.	28 days

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: lifestyle intervention; dietary intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: 2020P000625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No