GOS to Reduce Symptom Severity in IBS
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NL-OMON26014
- Lead Sponsor
- Clasado Research Services Ltd
- Brief Summary
Planned
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 210
1.Diagnosed with IBS within 36 months prior to study entry
2.Confirmed IBS according to Rome-IV criteria (determined by Investigator)
3.An IBS Symptom Severity Scale score of =125 points at baseline
4.Male or female between 18 and 64 years of age (age ranges included)
5.Possession of a smartphone
6.Willing and eligible to provide consent and comply with protocol and product intake.
1.Unclassifiable IBS (IBS-U) as determined by Investigator
2.Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry.
oRegular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion.
3.Systemic antibiotic or antimycotic treatment within 4 weeks prior to study entry
4.Use of laxatives or antidiarrheal medication within 4 weeks prior to study entry
5.Use of high-dose antidepressants/antipsychotics (>50mg) within 6 months prior to study entry. Low-dose antidepressants/antipsychotics should be stable for 3 months prior to study entry.
6.Confirmed lactose intolerance, defined as patients who report response to dietary elimination of lactose/dairy products. Confirmation is patient-reported and not done within the scope of this study.
7.Confirmed food allergy, with reported confirmation based on OFC, IgE, or skin prick test. Confirmation is patient-reported and not done within the scope of this study.
8.Galactosemia (galactose metabolism disorder)
9.Following diets likely to affect study outcomes, including:
olow FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein, sugar-free, single-food, juicing/any day of juicing, any other restriction diet (e.g. very low calory), or vegan diets (GOS is derived from cow’s milk).
10.Severe illness(es) or medical condition(s), including gastrointestinal pathologies:
oulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel resection, auto-immune diseases (e.g. Rheumatoid Arthritis, Systemic lupus erythematosus, Multiple Sclerosis, Graves’ Disease), bariatric surgery, acute or chronic diarrhoea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition
11.Surgical operations to the mouth or gastrointestinal tract within 4 weeks prior to study entry, or planned during the study
oAppendectomy within 6 months prior to study entry
12.Recent unintended weight loss:
o>5% of total body weight within 6 months prior to study entry
13.Excessive alcohol consumption (>10 units per week) and/or drug abuse
14.Pregnancy and lactation, or plan to become pregnant during the study period
15.Participation in other studies involving investigational or marketed products concomitantly or within 3 months prior to study entry
16.Changes in diet, supplement use or medication likely to affect study outcomes within 3 months prior to study entry or planned during the study (at the discretion of the Investigator).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in total IBS symptom severity between treatment arms as measured by mean composite IBS Symptom Severity Scale scores at the end of the study (Day 56).
- Secondary Outcome Measures
Name Time Method