A Clinical Trial Evaluating Diets for IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

A Randomized Clinical Trial Evaluating Two Different Diets for IBS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831306
• Other study ID #: 2020P000625
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Johanna Iturrino Moreda, MD
• Phone: 6176672138
• Email: jiturrin[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Other:
• Diet A
Modified Diet A
• Diet B
Modified Diet B

Locations

Country	Name	City	State
United States	University of Michigan - Ann Arbor	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Irritable Bowel Syndrome - Symptom Severity Score	Change in IBS-SSS as compared with baseline.	28 days
Secondary	Adequate Relief	Proportion of subjects who experience adequate relief compared with baseline.	28 days