Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum
研究概览
简要总结
Background:
Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health.
Objective:
To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk.
Eligibility:
Healthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions).
Design:
Participants will have 2 clinic visits.
The first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study.
Eligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person.
The supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal.
The second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.
详细描述
Study Description:
This pilot proof-of-principle (PoP) study will investigate mechanisms of action of a human milk oligosaccharide (HMO)-based synbiotic supplement, Cardiosyn (a combination of prebiotics and pro-biotics). Synbiotics for gut microbiota are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions, and normalizing blood lipids and iron markers in healthy human subjects.
Objectives:
Primary Objective:
To measure changes in microbiome determined by the increase of the population of Lactobacillus Plantarum and Bifidobacterium Bifidum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Healthy males and females between the ages 18 to
- •Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
- •Subjects taking no medications, with a few exceptions (sporadic medication and medications known to not significantly affect the microbiome, per PI discretion).
- •Screening labs within normal levels. Deviations of the screening labs from normal levels up to CTCAE v5, grade 1 are allowed per PI discretion.
排除标准
- •Pregnancy or women currently breastfeeding.
- •Subjects currently on other prebiotics and/or probiotics supplementation.
- •Subjects that are vegetarians or vegans or not on a typical western diet.
- •Subjects planning to initiate new medications or already taking medications that may interfere or modify gut microbiome.
- •Subjects with allergy or known hypersensitivity to any components of the supplement.
- •Subjects with weight changes greater than 20% over the past 3 months.
- •Subjects planning a significant change in diet or exercise levels.
- •Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.
- •Anticipated surgery during the study period.
- •Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant.
研究组 & 干预措施
Cardiosyn in Healthy Volunteers
Participants will receive 2 doses of Cardiosyn daily by mouth (2 sachets) for a total of 16.2 grams. Each does (sachet) is 8.1 grams.
干预措施: Cardiosyn (Dietary Supplement)
结局指标
主要结局
Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum
时间窗: 8 weeks
To assess changes in the microbiome, we will measure the increase in the populations of Lactobacillus plantarum and Bifidobacterium bifidum.
次要结局
- Reported intake by the subject and counting the number of remaining supplement(8 weeks)
- Mean change of biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin in plasma(8 weeks)
- Fold increase in Lactobacillus or Bifidobacterium over baseline(8 weeks)
- Number of participants that tolerated symbiotic supllementation(8 weeks)
- Number of gastrointestinal symptoms reported by participants using Common Terminology Criteria for Adverse Events version 5.0(8 weeks)