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Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet low in all FODMAP groups
Diet - Mediterranean
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Low FODMAP Diet, Mediterranean Diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype) diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiac disease, microscopic colitis, inflammatory bowel disease) Aged 18-70 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 percent compliance in daily questionnaire entries during the 7-day screening period Exclusion Criteria: Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-free diet, Mediterranean currently or within the past 6 months Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study). Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., 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. Subjects with prior small bowel or colonic surgery (excluding appendectomy or cholecystectomy if over 6 months since these 2 procedures) Oral antibiotic use in the past 3 months Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study. Currently pregnant or breastfeeding.

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diet low in all FODMAP groups

Diet - Mediterranean

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients that are responders based on the abdominal pain intensity score for at least 2 of the 4 weeks
The abdominal pain score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal pain and 10 represents the worst possible abdominal pain. Once per day, subjects will report worst daily (in the past 24 hours) abdominal pain. Proportion of patients that would be weekly responders to abdominal pain for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.

Secondary Outcome Measures

Proportion of patients that are weekly responders to adequate relief symptom assessment for at least 2 of the 4 weeks
Subjects will provide a binary (yes or no) response to rate the adequacy of relief of global IBS symptoms at the start of the study and weekly thereafter. Adequate relief - Proportion of patients that would be weekly responders to adequate relief symptom assessment for at least 2 of the 4 weeks. A weekly responder is defined as adequate relief in symptoms in at least 2 out of 4 weeks of the treatment period.
Proportion of patients that are weekly responders based on the Irritable Bowel Severity Scoring System (IBS-SSS) modified version for at least 2 of the 4 weeks
There are 5 questions that subjects will answer regarding their stomach and bowels. The total score that is calculated for this modified version (0-500). IBS-SSS - Proportion of weekly responders for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly IBS-SSS score of at least 50 points compared with baseline.
Change in mean score of the Irritable Bowel Severity Scoring System (IBS-SSS) modified version
There are 5 questions that subjects will answer regarding their stomach and bowels. The total score that is calculated for this modified version (0-500).
Proportion of patients that are weekly responders to bloating for at least 2 of the 4 weeks
The abdominal bloating score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal bloating and 10 represents the worst possible abdominal bloating. Once per day, subjects will report their worst daily (in the past 24 hours) abdominal bloating. Bloating - Proportion of patients who would be weekly responders to bloating for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly average of worst bloating in the past 24 hours score of at least 30% compared with baseline. The abdominal bloating score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal bloating and 10 represents the worst possible abdominal bloating. Once per day, subjects will report their worst daily (in the past 24 hours) abdominal bloating
Proportion of patients that are weekly responders to stool consistency based on the Bristol Stool Scale (BSS) for at least 2 of the 4 weeks
A stool consistency weekly responder will be defined as a 50% or greater reduction in the number of days per week with at least one abnormal stool (defined as BSS 1 or 2 or 6 or 7) Stool consistency: Proportion of patients who would be weekly responders to stool consistency assessment for at least 2 of the 4 weeks.

Full Information

First Posted
March 29, 2023
Last Updated
September 6, 2023
Sponsor
University of Michigan
Collaborators
ModifyHealth, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05807919
Brief Title
Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)
Official Title
Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
ModifyHealth, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS). The study team hypothesizes that: The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Low FODMAP Diet, Mediterranean Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects meeting all eligibility criteria will be randomized in a 1:1 ratio to receive either the MD or the LFD for a four-week period.
Masking
ParticipantInvestigator
Masking Description
Participant and investigators will not know what study cohort participants have been randomized into.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet low in all FODMAP groups
Arm Type
Experimental
Arm Title
Diet - Mediterranean
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Diet low in all FODMAP groups
Intervention Description
Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
Intervention Type
Other
Intervention Name(s)
Diet - Mediterranean
Intervention Description
Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
Primary Outcome Measure Information:
Title
Proportion of patients that are responders based on the abdominal pain intensity score for at least 2 of the 4 weeks
Description
The abdominal pain score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal pain and 10 represents the worst possible abdominal pain. Once per day, subjects will report worst daily (in the past 24 hours) abdominal pain. Proportion of patients that would be weekly responders to abdominal pain for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients that are weekly responders to adequate relief symptom assessment for at least 2 of the 4 weeks
Description
Subjects will provide a binary (yes or no) response to rate the adequacy of relief of global IBS symptoms at the start of the study and weekly thereafter. Adequate relief - Proportion of patients that would be weekly responders to adequate relief symptom assessment for at least 2 of the 4 weeks. A weekly responder is defined as adequate relief in symptoms in at least 2 out of 4 weeks of the treatment period.
Time Frame
4 weeks
Title
Proportion of patients that are weekly responders based on the Irritable Bowel Severity Scoring System (IBS-SSS) modified version for at least 2 of the 4 weeks
Description
There are 5 questions that subjects will answer regarding their stomach and bowels. The total score that is calculated for this modified version (0-500). IBS-SSS - Proportion of weekly responders for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly IBS-SSS score of at least 50 points compared with baseline.
Time Frame
4 weeks
Title
Change in mean score of the Irritable Bowel Severity Scoring System (IBS-SSS) modified version
Description
There are 5 questions that subjects will answer regarding their stomach and bowels. The total score that is calculated for this modified version (0-500).
Time Frame
Baseline, 4 weeks
Title
Proportion of patients that are weekly responders to bloating for at least 2 of the 4 weeks
Description
The abdominal bloating score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal bloating and 10 represents the worst possible abdominal bloating. Once per day, subjects will report their worst daily (in the past 24 hours) abdominal bloating. Bloating - Proportion of patients who would be weekly responders to bloating for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly average of worst bloating in the past 24 hours score of at least 30% compared with baseline. The abdominal bloating score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal bloating and 10 represents the worst possible abdominal bloating. Once per day, subjects will report their worst daily (in the past 24 hours) abdominal bloating
Time Frame
4 weeks
Title
Proportion of patients that are weekly responders to stool consistency based on the Bristol Stool Scale (BSS) for at least 2 of the 4 weeks
Description
A stool consistency weekly responder will be defined as a 50% or greater reduction in the number of days per week with at least one abnormal stool (defined as BSS 1 or 2 or 6 or 7) Stool consistency: Proportion of patients who would be weekly responders to stool consistency assessment for at least 2 of the 4 weeks.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype) diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiac disease, microscopic colitis, inflammatory bowel disease) Aged 18-70 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 percent compliance in daily questionnaire entries during the 7-day screening period Exclusion Criteria: Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-free diet, Mediterranean currently or within the past 6 months Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study). Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., 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. Subjects with prior small bowel or colonic surgery (excluding appendectomy or cholecystectomy if over 6 months since these 2 procedures) Oral antibiotic use in the past 3 months Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study. Currently pregnant or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prashant Singh, MD
Phone
734-936-6400
Email
singhpr@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashant Singh, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
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
Phone
734-936-6400
Email
singhpr@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Prashant Singh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)

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