Defining Objective Markers of Compliance for Dietary Ther... | NCT07494968

Studies
Defining Objective Markers of Compliance for Dietary Therapies in IBS

NCT07494968

Sponsor

University of Michigan

Status

Recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

94Estimated

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

Diet A - elimination diet
Diet B - healthy eating diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2026Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Mar 20, 2026

First Submission Date that Met QC Criteria

Mar 20, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2026

Last Update Posted Date

Jun 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diet A - elimination diet	Experimental		Behavioral: Diet A - elimination diet
Diet B - healthy eating diet	Active Comparator		Behavioral: Diet B - healthy eating diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Prashant Singh, MBBS	Contact	734-647-9252		singhpr@umich.edu

Name	Affiliation	Role
Prashant Singh, MBBS	University of Michigan	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan	Recruiting	Ann Arbor	Michigan	48109	United States

ID	Term
D043183	Irritable Bowel Syndrome

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Masking Info

Masking

Double

Masking Description

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.

Who Masked

InvestigatorOutcomes Assessor