Irritable Bowel SyndromeNCT07494968
Defining Objective Markers of Compliance for Dietary Therapies in IBS
A study testing Diet A - elimination diet and Diet B - healthy eating diet in people with Irritable Bowel Syndrome, run by University of Michigan at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diet A - elimination diet and Diet B - healthy eating diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Prashant Singh, MBBS, 734-647-9252, singhpr@med.umich.edu
Prashant Singh, MBBS
About this study
Official title: 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
Read the 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.)
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diet A - elimination diet, Diet B - healthy eating diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet A - elimination dietBehavioural
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 B - healthy eating dietBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Diet A - elimination diet | Experimental | Not described Receives: Behavioral: Diet A - elimination diet |
| Diet B - healthy eating diet | Active comparator | Not described Receives: Behavioral: Diet B - healthy eating diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between fecal GIP excretion and fructo-oligosaccharide intake
Assessed using 24-hour recall
Measured: Week 4
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start11 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Singh, University of Michigan
- Investigators
- Prashant Singh, MBBS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494968
- Sponsor's protocol ID
- HUM00285706
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07494968
- Acronym / sponsor ID
- HUM00285706
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet A - elimination diet | Experimental | Behavioral: Diet A - elimination diet |
| Diet B - healthy eating diet | Active comparator | Behavioral: Diet B - healthy eating diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet A - elimination dietCombined 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. | Behavioural | Diet A - elimination diet |
| Diet B - healthy eating dietThe 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 | Behavioural | Diet B - healthy eating diet |
Primary outcome
Correlation between fecal GIP excretion and fructo-oligosaccharide intake
Time frame: Week 4
Assessed using 24-hour recall
3 secondary outcomes
The Irritable Bowel Severity Scoring System (IBS-SSS) score
Time frame: Week 4
Patient-Reported Outcomes Measurement Information System (PROMIS) abdominal pain score
Time frame: Week 4
PROMIS bloating score
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prashant Singh, MBBS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet A - elimination diet and Diet B - healthy eating diet in people with Irritable Bowel Syndrome, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prashant Singh, MBBS (734-647-9252, singhpr@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between fecal GIP excretion and fructo-oligosaccharide intake (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.