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ID
Source
Brief title
Health condition
Irritable Bowel Syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
I. The difference in abdominal pain between treatment groups as measured by the mean abdominal pain symptom scores during the intervention period.
II. The difference in bloating between treatment groups as measured by the mean bloating symptom scores during the intervention period.
III. The difference in global IBS improvement between treatment arms as measured by the mean IBS Global Improvement Scale scores during the intervention period.
IV. The difference in stool consistency between treatment arms, per subtype of IBS, as measured by the median Bristol Stool Form Scale stool type during the intervention period.
V. The difference in defecation frequency between treatment arms, per subtype of IBS, as measured by the mean patient-reported defecation frequency during the intervention period.
VI. The difference in quality of life between treatment arms as measured by the mean composite IBS Quality of Life scores at the end of the study (Day 56).
VII. The difference in anxiety and depression between treatment arms, evaluated separately using the mean IBS Hospital Anxiety and Depression Scale scores at the end of the study (Day 56).
VIII. Nature, incidence, frequency, severity of adverse events/serious adverse events and relationship to the study intervention.
Background summary
This is a Phase III, randomized, double-blind, placebo-controlled, multi-centre, 8-week intervention study, preceded by a 2-week run-in period, to assess the efficacy of (specific) galacto-oligosaccharides (GOS) on symptom severity in adult patients with IBS. The study population will consist of 210 adult patients diagnosed in the past 36 months with IBS-Diarrhoea (N =70), IBS-Constipation (N = 70), or IBS-Mixed (N =70). The study will be conducted in 5 sites in The Netherlands, Belgium and the UK.
Irritable bowel syndrome (IBS) is a highly prevalent and multifaceted functional bowel disorder characterized by recurrent abdominal pain associated with defecation or a change in bowel habits in the absence of detectable structural and biochemical abnormalities (Rome IV Criteria). Disordered bowel habits are typically present, such as constipation, diarrhoea or a mix of constipation and diarrhoea, as are symptoms of abdominal bloating/distension. The chronic and bothersome nature of IBS symptoms negatively affects patient quality of life and introduces a substantial economic burden on patients and the healthcare system. The gut microbiota composition and function may play a pivotal role in the pathogenesis of IBS, as a reduction in endogenous bifidobacteria, lactobacilli, and Faecalibacterium prausnitzii concentrations, as well as small bowel bacterial overgrowth have been reported in IBS patients, thereby introducing the gut microbiota as a potential target for treatment and symptom relief. Intervention with non-digestible food ingredients, such as GOS, may form a suitable intervention strategy, as these ‘prebiotics’ are known to modulate the gastrointestinal (GI) microbiota and support health and wellbeing of the host. The safety and efficacy of GOS has previously been evaluated in patients with IBS, which demonstrated that GOS may reduce IBS symptom severity, improve quality of life, improve stool consistency and defecation frequency and alter gut microbiota composition, in a safe manner. As there are currently limited suitable medical treatments for IBS, this study will evaluate the efficacy of a dietary supplement with GOS, in reducing symptom severity of patients with IBS.
Study objective
Let µT denote the mean value of the composite IBS-SSS score under treatment with the active / GOS and µP denote the mean value of the composite IBS-SSS score under placebo, then the primary two-sided hypothesis to be tested is:
• H0: µT - µP = 0 (i.e. no statistically significant change in IBS symptom severity after treatment)
• H1: µT - µP ≠ 0 (i.e. a statistically significant change in IBS symptom severity after treatment)
Success of the outcome is defined as statistically significant lower IBS-SSS scores at the end of the study (Day 56) in the active test group compared with placebo in the Intention-to-Treat population.
Study design
Day -14 (Screening and ICF)
Run-in (2 weeks)
Day 0 (Randomization)
Week 1
Week 2
Week 4
Week 8 (End of study)
Intervention
GOS & Placebo
Inclusion criteria
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.
Exclusion criteria
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.
o Regular 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:
o low 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:
o ulcers, 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
o Appendectomy 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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9317 |
| Other | BEBO : Pending |