Health TrialsbyHealthPanel

Defining Objective Markers of Compliance for Dietary Therapies in IBS

ConditionIrritable Bowel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Michigan

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Diet B - healthy eating diet

    Behavioral

    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

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Diet A - elimination dietExperimental treatment 1 intervention
Group B: Diet B - healthy eating dietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between fecal GIP excretion and fructo-oligosaccharide intake

Assessed using 24-hour recall

Time frame
Week 4

Secondary outcomes

1

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.

Time frame
Week 4
2

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.

Time frame
Week 4
3

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.

Time frame
Week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov
Apply now