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

Irritable Bowel Syndrome Clinical Trial

Official title:

Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807919
• Other study ID #: HUM00227491
• Secondary ID: 5P30DK089503-13
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Prashant Singh, MD
• Phone: 734-936-6400
• Email: singhpr[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Diet low in all FODMAP groups
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.
• Diet - Mediterranean
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	ModifyHealth, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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).	Baseline, 4 weeks
Secondary	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	4 weeks
Secondary	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.	4 weeks