A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Assessment of Gut Microbiome
研究概览
简要总结
The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms
详细描述
This is a double-blind, randomized, placebo-controlled, remote design study to evaluate the effects of a Butyrate formulation and Butyrate + Polyphenol formulation on gut health, intestinal permeability and associated symptoms.
Participants will be asked to complete laboratory assessments and questionnaires. A total of up to 105 subjects (35 subjects per arm) will be enrolled in a randomly assigned sequence for the 28-day period. There will be scheduled remote video calls during the study.
The study subjects will complete assessment tools that include a Rating Scale for Gastrointestinal Symptoms, Quality of Life Questionnaire for Digestion, Visual Analogue Scale of Abdominal Pain, Stool Form Scale, Global Assessment of Improvement Scale-Gastrointestinal and the Short Form-36 Health Survey (SF-36). Laboratory testing will include an assessment of Gut Microbiome, analysis of Short Chain Fatty Acids, a panel for the Gut Barrier and Intestinal Permeability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ambulatory, male or female, 21-70 years of age
- •A BMI of 18.5 -34.9
- •. Experiences at least three conditions involving gastrointestinal health on a weekly basis
- •Are comfortable fasting overnight
- •Are able to complete study procedures for up to approximately 6 hours on 2 separate days
- •Considered to be generally healthy on the basis of medical history
- •Willing to follow study instructions, including compliance with the study procedures and requirements
排除标准
- •Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
- •Currently on a galactose/lactose restricted diet
- •Having taken proton pump inhibitors within the past 3 months
- •History of oral antibiotic use within the past 3 months
- •Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters
- •A medical or surgical event requiring hospitalization, outpatient visits or emergency room visits within the past 5 years or in the judgment of the Study Investigator /Sub-I would preclude participation in the study
- •Current or previous history of diabetes
- •History of a major change in dietary habits with the past 1 month
- •Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose
- •Women who are lactating, pregnant or planning pregnancy within the next two months
- •Having donated blood or received a blood transfusion within 30 days before screening
- •Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening
结局指标
主要结局
Assessment of Gut Microbiome
时间窗: 28 days
Assessment of the median change in the results of the Gut Microbiome from baseline.
The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version
时间窗: 28 days
Assessment of the median change in the responses on the Gastrointestinal Symptom Rating Scale-IBS from baseline. This scale has questions about how you have been feeling and what it has been like in the past week. The responses to each question range from no discomfort at all to very severe discomfort which would indicate a worse outcome.
次要结局
- Gut Barrier Panel(28 days)
- Short Chain Fatty Acids (SCFA)(28 days)
- Intestinal Permeability Test(28 days)
- Digestion - Associated Quality of Life Questionnaire (DQLQ)(28 days)
- Visual Analogue Scale (VAS) of abdominal pain(28 days)
- Bristol Stool Form Scale (English for United States)(28 days)
- Gastrointestinal- Global Assessment of Improvement Scale (Gastrointestinal-GAI)(28 days)
- Short Form-36 Health Survey (SF-36 Health Survey)(28 days)