NL-OMON51897招募中3 期
A Multi-centre, Randomized, Placebo-Controlled, Efficacy Study of Prebiotic Galacto-oligosaccharides on Gastrointestinal Symptom Severity in Patients with Irritable Bowel Syndrome - GOS to Reduce Symptom Severity in IBS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Patients who have been diagnosed with IBS by a medically trained
- •person/Health Care Professional (HCP).
- •2. IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary
- •or secondary care clinician, including a gastroenterologist, at study entry
- •3. An IBS Symptom Severity Scale score of >=125 points at baseline (V1)
- •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
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 (e.g. Yakult, Actimel, Activia, VSL#3, Kefir).
- •o Regular cheese or yogurt containing lactic acid bacteria are not an exclusion
- •3. Systemic antibiotic or antimycotic treatment within 4 weeks prior to study
- •4. Use of laxatives or antidiarrheal medication within 1 week prior to study
- •5. An unstable antidepressant/antipsychotic treatment regimen within 3 months
- •prior to study entry (i.e. treatment should be stable for at least 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 GI ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel
- •resection, , bariatric surgery, acute or chronic diarrhoea secondary to
- •confirmed infectious gastroenteritis, or enteral or parenteral nutrition.
- •11. Subjects suffering from auto-immune disorders (e.g. Rheumatoid Arthritis,
- •Systemic lupus erythematosus, Multiple Sclerosis, Graves* Disease) that require
- •treatment with an immune modulator treatment or anti-inflammatory medication
- •12. 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
- •13. Recent unintended weight loss:
- •o >5% of total body weight within 6 months prior to study entry
- •14. Excessive alcohol consumption (>14 units per week) and/or drug abuse
- •15. Pregnancy and lactation, or plan to become pregnant during the study period
- •16. Participation in other studies involving investigational or marketed
- •products concomitantly or within 3 months prior to study entry
- •17. Changes in diet, supplement or medication use likely to affect study
- •outcomes (i.e. medication that influences GI function) within 4 weeks prior to
- •study entry or planned during the study (at the discretion of the
- •Investigator). For example, the following medications will influence GI
- •function and changes must be avoided: opioids, prokinetics (domperidone,
- •metoclopramide, prucalopride), antispasmodics (peppermint oil, buscopan), and
- •acid suppressants (PPI, H2 blockers). Of note: the intake of fibres (e.g.
- •psyllium husk) may be used provided that the participant has been using this as
- •a supplement for more than 4 weeks prior to study participation and intake does
- •not change during the course of participation.
研究者
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