Galactooligosaccharides (GOS) Promote the Proliferation of Bifidobacteria and May be a Viable Management Strategy for Lactose Intolerance Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Increase in the relative abundance of the genus Bifidobacterium and other lactose-metabolizing genera
研究概览
简要总结
The purpose of this study was to identify specific microbes that change with supplementation with galactooligosaccharides-prebiotics that are associated with alleviation of lactose intolerance symptoms in lactose-intolerant human subjects.
详细描述
The experimental design of this study was a completely randomized placebo-controlled clinical trial study, which consisted of a one-week screening period followed by a 3-week supplementation period and a 3 week-washout period. Institutional Review Board (IRB) approval was obtained through Oregon State University's Regional Institutional Review Board (IRB Number IRB-2021-1044) and written informed consent was obtained from all participants.
During the supplementation period, participants were instructed to consume twice daily (morning and evening) either prebagged 5.2 g of GOS (treatment group) or 1 g of lactose (placebo), which the participants were instructed to dissolve in 250ml of water and consume either before or after meals. The GOS (donated by FrieslandCampina, Amersfoort, the Netherlands, and sold under the trade name, BiotisTM GOS-O Powder) contained 73.7% GOS, 20.9% lactose, and 5.3% monosaccharides (galactose and glucose) and 1.0% ash. To account for the nutritional impact of lactose in the GOS supplement on host and microbiota, 1 g lactose, donated by Glanbia Nutritionals (Twin Falls, ID, USA), was given as a control in this study.
12 adults (2 males, 10 females), ages 19-55 years (mean: 29 years; SD: 11 years) started the clinical trial. During the study, participants continued with their regular diets that they recorded weekly in a food frequency questionnaire. The only dietary restrictions were: no consumption of dairy pills such as Lactaid, no pre/probiotic supplements, and antibiotics.
Fecal samples were collected weekly for the duration of the study. Participants used the Easy Sampler ® Stool Collection kit (ALPCO®, New Hampshire, USA) to collect samples and they dropped them off in the lab immediately after collection.
DNA was extracted from 200 mg of fecal samples via a QIAamp Powerfeccal Pro(Qiagen, Hilden, Germany).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Single-blind
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People with lactose intolerance (formal and informal diagnosis) Fluent in English People who have a primary care provider Have to be 18 years and older
排除标准
- •Any known gastrointestinal disease or disorder, or major gastrointestinal surgery Habitual use of laxatives or antacids Diabetes Pregnancy Use of antibiotics within one month prior to the study Use of pre or probiotics within one month prior to the study Any subject who, in the opinion of a physician, has a medical or psychological condition that would preclude them from completing the study Dairy protein allergy (not lactose intolerance) Use of lactose intolerance pills such as "Lactaid" should be avoided during the course of this study
研究组 & 干预措施
Treatment group (Galactooligosaccharides group(GOS))
During the supplementation period, participants were instructed to consume twice daily (morning and evening) prebagged 5.2 g of galactooligosaccharide (GOS) which the participants were instructed to dissolve in 250 ml of water and consume either before or after meals.
干预措施: Prebiotic galactooligosaccharides (GOS) (Dietary Supplement)
Control group (lactose group)
During the supplementation period, participants were instructed to consume twice daily (morning and evening) prebagged 1 g of lactose which the participant was instructed to dissolve in 250 ml of water and consume either before or after meals.
干预措施: Prebiotic galactooligosaccharides (GOS) (Dietary Supplement)
结局指标
主要结局
Increase in the relative abundance of the genus Bifidobacterium and other lactose-metabolizing genera
时间窗: 6 weeks
DNA was extracted from 200 mg of fecal samples Hilden, Germany). The concentration of extracted DNA was measured by Fluorometer, followed by a library construction targeting the V4 region of the 16S rRNA gene for microbiome sequencing. Microbiome compositional analysis and statistical analysis was performed to identify shifts in specific microbes over time with prebiotic GOS supplementation.
次要结局
未报告次要终点
研究者
Dave Dallas
Assistant Professor
Oregon State University