NL-OMON26014招募中不适用
A Multi-centre, Randomized, Placebo-Controlled, Efficacy Study of Prebiotic Galacto-oligosaccharides on Gastrointestinal Symptom Severity in Patients with Irritable Bowel Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
研究概览
简要总结
Planned
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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).
研究者
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