NCT07371975已完成不适用
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.
详细描述
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals.
Participants will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 25-70 years
- •Body mass index 18.5-34.9 kg/m2
- •A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may be included at the discretion of the PI/Sub-I
- •Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
- •Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
- •Weight stable for the past six months (±6 lbs.)
- •Willing and able to give written informed consent
- •Ability to communicate and read in English
- •Ability to comply with study requirements
排除标准
- •Currently participating in another clinical research study
- •Pregnant, planning pregnancy, or breastfeeding
- •Unable to swallow capsules, tablets, or softgels
- •Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.
- •Typically goes longer than 3 days without a bowel movement
- •Current diagnosis of cardiovascular disease, history of an abnormal electrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except for non-melanoma skin cancer) within the past 5 years
- •Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.
- •Planning to undergo a major medical procedure or surgical event within the next 30 days
- •Currently being treated for any infectious disease
- •Currently consuming more than 6 standard alcoholic drinks per week for women and 10 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
- •Smoking or use of nicotine products daily within 30 days prior to screening
- •Using substances of abuse or recreational drugs/substances, including tetrahydrocannabinol (THC), within the past 14 days
- •History of intolerance or allergic reaction to product ingredients, including butyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamon extract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)
- •Having donated blood or received a blood/plasma transfusion within 30 days before baseline
- •History of a major change in dietary habits within the past 1 month
- •Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation
- •Currently taking any laxatives on a daily basis
- •Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.
- •On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
- •History of oral or IV antibiotic use within the past 3 months prior to Baseline
- •Not willing to refrain from taking any over-the-counter medications or supplements for gastrointestinal concerns or discomfort (except if on a stable dose for > 3 months before Screening and unlikely to change) unless in the judgment of the PI/Sub-I
- •Current or previous history of medically diagnosed and treated gastrointestinal disease, including gallbladder problems, gallstones, biliary obstruction, inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiac disease, or gastrointestinal cancer
- •Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
- •Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month
- •Currently experiencing or previously having a parasitic infection within the past 3 months
- •Currently experiencing or having a history of severe endometriosis
- •History of gastrointestinal surgery, which might influence gastrointestinal function
- •History or presence of a clinically significant diagnosis or circumstance that, in the judgment of the Study Investigator/Sub-I, would interfere with the interpretation of the study results and preclude participation in the study -
研究组 & 干预措施
Butyrate + Polyphenol Formulation
Active Comparator
Butyrate + Polyphenol Formulation
干预措施: Butyrate + Polyphenol Formulation (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
时间窗: 14 days
Change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. The responses to the questions range from no discomfort at all to very severe discomfort which would indicate a worse outcome
Gut Microbiome Stool Test
时间窗: 14 days
Change in the Gut Microbiome (strain level, functional metrics, taxonomy abundance and composition) from baseline
次要结局
- Digestion-Associated Quality of Life Questionnaire (DQLQ)(14 days)
- Visual Analogue Scale (VAS) of abdominal pain(14 days)
- Bristol Stool Form Scale (BSFS)(14 days)
- Gastrointestinal -Global Assessment of Improvement Scale (Gastrointestinal-GAI)(14 days)
- World Health Organization Quality of Life (WHOQOL-BREF)(14 days)
研究者
研究点 (1)
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