Irritable Bowel Syndrome
Conditions
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.)
Interventions
BEHAVIORALDiet 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.
BEHAVIORALDiet 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
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between fecal GIP excretion and fructo-oligosaccharide intake | Week 4 | Assessed using 24-hour recall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Irritable Bowel Severity Scoring System (IBS-SSS) score | Week 4 | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) abdominal pain score | Week 4 | PROMIS abdominal pain scores are assessed using the PROMIS Belly Pain 5a which range from 5-25 and higher scores indicate worse symptoms. |
| PROMIS bloating score | Week 4 | 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. |
Countries
United States
Contacts
CONTACTPrashant Singh, MBBS
PRINCIPAL_INVESTIGATORPrashant Singh, MBBS
University of Michigan
Outcome results
None listed