A Randomized, Double-blind, Placebo-controlled, Parallel Group, Pilot Study on the Effect of a Novel Prebiotic, XOS95, on the Human Gut Microbiome

Prenexus Health1 个研究点分布在 1 个国家目标入组 75 人2017年3月1日

适应症Healthy

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Healthy
发起方: Prenexus Health
入组人数: 75
试验地点: 1
主要终点: Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces
状态: 已完成
最后更新: 7年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The purpose of this clinical trial is to assess the efficacy of a novel prebiotic, XOS95, at two different dosages, in comparison to a placebo by assessing shifts in microbial populations after 8 weeks of supplementation, assessed as changes in abundance of microbial populations.

注册库

clinicaltrials.gov

开始日期

2017年3月1日

结束日期

2017年9月28日

最后更新

7年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Prenexus Health

责任方

Sponsor

入排标准

入选标准

•Male or female adults aged 18 - 60 (inclusive)
•Healthy as determined from medical history
•Non-smoker, or ex-smoker ≥6 months
•Body mass index 18.5 - 27.5kg/m2 (inclusive)
•Female subjects of childbearing potential \[i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)\] must have negative urine pregnancy test and must be using an effective birth control method , defined as:
•Continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry , or
•Use of an intra-uterine device or implantable contraceptive, or
•Use of double barrier methods of birth control, or
•Abstinence from heterosexual intercourse
•Willing to avoid alcohol consumption for 24 h prior to every clinic visit

排除标准

•Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study
•Use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the counter non-steroidal anti-inflammatory drugs \>1month), steroids, corticosteroids, or any other prescription anti-inflammatory drugs within 3 months prior to visit 1
•Individuals taking any over the counter or prescription medications, including natural health products, that may alter lipid profiles including, but not limited to fish oil (omega-3 fatty acids), statins, fibrates, bile acid exchanger resin, phytosterols, niacin or its analogues, carnitine, polyglucosamines (Chitosan) or other lipid-binding ingredients within the 3 months prior to visit 1
•Individuals taking any over the counter or prescription medications, including natural health products that may alter blood glucose (e.g. biguanides (Metformin), Alpha-lipoic Acid (ALA), Gymnema sylvestre) or insulin modulating medications (e.g. sulfonylureas, meglitinides, D-phenylalanine derivatives, thiazolidinediones, DPP-4 inhibitors, alpha-glucosidase inhibitors, bile acid sequestrants within 3 months prior to visit 1
•Use of proton pump inhibitors or medications which inhibit peristaltic movement (e.g. opioids, loperamide)
•Unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1
•Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit
•Use of over the counter or prescription laxatives or stool softeners within 1 month prior to baseline (V2)
•Use of antibiotics (other than topical) within 2 months prior to baseline (V2)
•Use of prebiotic or fiber supplements (e.g. fructans and galacto-oligosaccharides (FOS, GOS), psyllium, fiber, inulin, glucomannan, acacia fiber/gum) or probiotic supplements (i.e. live microorganisms) within 4 weeks of baseline (V2)

结局指标

主要结局

Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces

时间窗: 8 weeks

次要结局

Effect of XOS95 on gastrointestinal bacterial counts in the feces(8 weeks)
Effect of XOS95 on fasting blood glucose(4 and 8 weeks)
Effect of XOS 95 on post-prandial glucose response(8 weeks)
Effect of XOS on abdominal discomfort assessed by daily questionnaire(4 and 8 weeks)
Effect of XOS95 on short chain fatty acid production measured in the feces(8 weeks)
Effect of XOS 95 on lipid profile parameters(4 and 8 weeks)
Effect of XOS 95 on C-reactive protein(8 weeks)
Effect of XOS on general well-being assessed by daily questionnaire(4 and 8 weeks)
Effect of XOS on total Gastrointestinal Quality of Life Index (GIQLI) scores(4 and 8 weeks)