Back to resultsA Clinical Trial Evaluating Diets for IBS
Primary Purpose
Irritable Bowel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet A
Diet B
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring dietary intervention, lifestyle intervention
Eligibility Criteria
Inclusion criteria 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 Exclusion criteria 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
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
- University of Michigan - Ann ArborRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diet A
Diet B
Arm Description
Modified Diet A
Modified Diet B
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
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.
Irritable Bowel Syndrome - Symptom Severity Score
Proportion of subjects who experience a 50-point and 100-point decrease in IBS-SSS compared with baseline.
Irritable Bowel Syndrome - Symptom Severity Score
Change in IBS-SSS as compared with baseline.
Adequate Relief
Proportion of subjects who experience adequate relief compared with baseline.
Full Information
NCT ID
NCT05831306
First Posted
April 14, 2023
Last Updated
April 27, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05831306
Brief Title
A Clinical Trial Evaluating Diets for IBS
Official Title
A Randomized Clinical Trial Evaluating Two Different Diets for IBS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
dietary intervention, lifestyle intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet A
Arm Type
Experimental
Arm Description
Modified Diet A
Arm Title
Diet B
Arm Type
Experimental
Arm Description
Modified Diet B
Intervention Type
Other
Intervention Name(s)
Diet A
Intervention Description
Modified Diet A
Intervention Type
Other
Intervention Name(s)
Diet B
Intervention Description
Modified Diet B
Primary Outcome Measure Information:
Title
Abdominal Pain Intensity
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Abdominal Discomfort Intensity
Description
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.
Time Frame
28 days
Title
Composite Score
Description
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
Time Frame
28 days
Title
Abdominal Bloating Intensity
Description
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.
Time Frame
28 days
Title
Stool Consistency
Description
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.
Time Frame
28 days
Title
Irritable Bowel Syndrome - Symptom Severity Score
Description
Proportion of subjects who experience a 50-point and 100-point decrease in IBS-SSS compared with baseline.
Time Frame
28 days
Title
Irritable Bowel Syndrome - Symptom Severity Score
Description
Change in IBS-SSS as compared with baseline.
Time Frame
28 days
Title
Adequate Relief
Description
Proportion of subjects who experience adequate relief compared with baseline.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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
Exclusion criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Iturrino Moreda, MD
Phone
6176672138
Email
jiturrin@bidmc.harvard.edu
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Proctor
Email
sprocto1@bidmc.harvard.edu
Facility Name
University of Michigan - Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prashant Singh, MD
Email
singhpr@med.umich.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial Evaluating Diets for IBS
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