Defining Objective Markers of Compliance for Dietary Therapies in IBS

NCT07494968 | Not Yet Recruiting

• 1 other identifier: HUM00285706
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This research will investigate if a specific marker in your stool or urine can be used to track changes in your carbohydrate intake including fructo-oligosaccharide and mannitol intake

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Correlation between fecal GIP excretion and fructo-oligosaccharide intake

  Assessed using 24-hour recall

  Week 4

Secondary Outcomes (3)

• The Irritable Bowel Severity Scoring System (IBS-SSS) score

  Week 4

• Patient-Reported Outcomes Measurement Information System (PROMIS) abdominal pain score

  Week 4

• PROMIS bloating score

  Week 4

Study Arms (2)

Diet A - elimination diet

EXPERIMENTAL

Behavioral: Diet A - elimination diet

Diet B - healthy eating diet

ACTIVE COMPARATOR

Behavioral: Diet B - healthy eating diet

Interventions

Diet A - elimination diet BEHAVIORAL

Combined oligosaccharide intake (fructans plus galacto-oligosaccharides) will be limited to \<0.50 grams per serving (same as above), while polyols, lactose, and fructose will not be limited.

Diet A - elimination diet

Diet B - healthy eating diet BEHAVIORAL

The subjects will be instructed to regularly eat 3 meals and 3 snacks a day, never too much or too little each time, never to be hungry or too full; to eat in peace and quiet and to chew thoroughly; drinks at least 8 cups of fluids a day, reduce intake of fatty or spicy foods, coffee, alcohol; avoid soft drinks and carbonated beverages, chewing gums, and sweeteners that ends with -ol, and to eat fibers with focus on soluble fibers such as oats but distribute the intake evenly during the day

Diet B - healthy eating diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with IBS ( including diarrhea, mixed or constipation type) and without unexplained alarm features (rectal bleeding, weight loss, nocturnal pain, nocturnal diarrhea). In presence of alarm symptoms, if they have had evaluation with colonoscopy or fecal calprotectin or serum C-reactive protein (CRP) since onset of alarm symptoms with normal results, they will be included.
• Aged 18-65 years at the time of screening
• IBS-SSS of at least 175 at baseline

You may not qualify if:

• Subjects adhering to a dietary treatment such as the low-fat diet, low FODMAP diet, or gluten-free diet, within the past 6 months. Those who are lactose intolerant will not be excluded from the study and will be allowed to limit lactose intake as previously.
• Subjects who are predicted to make changes to their baseline IBS medication(s), over-the-counter (OTC) therapy, exercise, diet (beyond what is advised), or initiate/make changes to other complementary therapy that could affect IBS symptoms (e.g. yoga, acupuncture, etc.) during the four weeks study period.
• 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
• Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).
• History of appendectomy or cholecystectomy in the last 6 months.
• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Prashant Singh, MBBS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prashant Singh, MBBS

CONTACT

734-647-9252; singhpr@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will know that both diets (FODMAP-simple and BDA/NICE) are predicted to help improve their IBS symptoms, but will not know that we are specifically investigating the role of FODMAPs. Instead, participants will be informed they are receiving either Diet A, Diet B differing in the types and amounts of specific foods provided. Furthermore, study coordinators will be blinded to which diet the participant receives. Also, Site PIs and co-Is will also be blinded to the randomization.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)