Defining Objective Markers of Compliance for Dietary Therapies in IBS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet A - elimination diet, Diet B - healthy eating diet.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial
Overview
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.)
Interventions
- 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. - 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
Primary outcome measures
- Correlation between fecal GIP excretion and fructo-oligosaccharide intake [Time frame: Week 4]
Secondary outcome measures (3)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT07494968 · HUM00285706