Defining Objective Markers of Compliance for Dietary Therapies in IBS

Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Diet A - elimination diet; Behavioral: Diet B - healthy eating diet

Detailed Description

The primary purpose of this study is to evaluate if an objective biomarker can be used to evaluate the amount of specific carbohydrate intake. It is to measure the coloration between Gluten immunogenic Peptides (GIP) and fructo-oligosaccharide intake(on 24-hour diet recall) at Week 4 to identify an objective biomarker for dietary content evaluation which is critical for dietary treatment.

The researchers hope GIP can be used to evaluate the amount of carbohydrate intake in clinical practice.)

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prashant Singh, MBBS; Phone Number: 734-647-9252; Email: singhpr@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
      • Contact: Prashant Singh, MBBS; Phone Number: 734-647-9252; Email: singhpr@med.umich.edu
      • Principal Investigator: Prashant Singh, MBBS
      • Sub-Investigator: Allen Lee, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Aged 18-65 years at the time of screening
3. IBS-SSS of at least 175 at baseline

Exclusion Criteria:

1. 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.
2. 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.
3. Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
4. Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
5. BMI < 18.5
6. Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).
7. History of appendectomy or cholecystectomy in the last 6 months.
8. Oral antibiotic use in the past 3 months
9. Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
10. Currently pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet A - elimination diet	Behavioral: Diet A - elimination diet; 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.
Active Comparator: Diet B - healthy eating diet	Behavioral: Diet B - healthy eating diet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between fecal GIP excretion and fructo-oligosaccharide intake	Assessed using 24-hour recall	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Irritable Bowel Severity Scoring System (IBS-SSS) score	The Irritable Bowel Severity Scoring System (IBS-SSS) is a questionnaire used for evaluating the severity of IBS with a maximum score of 500. Higher scores indicate increased pain.	Week 4
Patient-Reported Outcomes Measurement Information System (PROMIS) abdominal pain score	PROMIS abdominal pain scores are assessed using the PROMIS Belly Pain 5a which range from 5-25 and higher scores indicate worse symptoms.	Week 4
PROMIS bloating score	PROMIS bloating scores are assessed using the PROMIS Gas and Bloating 13a (PROGB has 13 questions with scores ranging from 12-60. Higher scores indicate worse symptoms.	Week 4

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Prashant Singh, MBBS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: HUM00285706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No