NCT07163637已完成不适用
A Randomized, Double-Blind, Placebo-Controlled Decentralized Trial to Assess the Effect and Tolerability of Limosilactobacillus Reuteri DSM 17648 Supplement in Healthy Adults Reporting Upper Gastrointestinal Discomfort
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks
研究概览
简要总结
The goal of this clinical trial is to learn if the food supplement containing a postbiotic (inanimate) Limosilactobacillus reuteri DSM 17648 works to improve the symptoms of upper gastrointestinal discomfort in healthy adults. The main questions it aims to answer are:
- Does L. reuteri DSM 17648 reduce the frequency of the symptoms of upper gastrointestinal discomfort, including acid reflux-related and dyspeptic symptoms, and its relief rate, over 8 weeks of intake?
- Does L. reuteri DSM 17648 improve gastrointestinal-related quality of life, and perceived stress?
- How well do participants tolerate the L. reuteri DSM 17648 supplement?
- Does L. reuteri DSM 17648 have an effect on the gut microbiota? (Exploratory aim)
Researchers will compare supplement containing L. reuteri DSM 17648 to a placebo (a look-alike supplement capsule that contains no L. reuteri DSM 17648).
Participants will:
- Take L. reuteri DSM 17648 supplement or a placebo every day for 8 weeks
- Answer questionnaires once every 2 weeks
- Provide stool samples for microbiome assessment at 2 timepoints (baseline and end of study (8 weeks))
- provide weekly information on investigational product intake and any adverse event records
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female.
- •Anyone with a BMI less than or equal to 32 kg/m².
- •Be aged 30-
- •Anyone currently experiencing occasional upper gastrointestinal discomfort (approximately 2 times/week over the past month), including the following:
- •Upper abdominal pain
- •Pain or burning in the stomach
- •Anyone with an FSSG (Frequency Scale for the Symptoms of GERD) total score of 8 or above.
- •Anyone who is generally healthy - does not live with any uncontrolled chronic health conditions, such as cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
- •Willing to avoid introducing any new supplements, over-the-counter medications, or herbal remedies for the duration of this trial
- •If taking other supplements, over-the-counter medications, or herbal remedies unrelated to gut health, has been doing so consistently for a minimum of three months.
- •Willing to maintain current diet, sleep pattern, and activity levels for the duration of the trial.
- •Resides in the United States.
排除标准
- •1. Anyone with any allergies or sensitivities to any of the study product ingredients.
- •2. Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- •3. Anyone unwilling to follow the study protocol.
- •Anyone taking any supplement, over-the-counter medication, or herbal remedy targeting gut health.
- •5. Anyone with a known history of severe digestive disorders like GERD (Gastroesophageal Reflux Disease) and FD (Functional Dyspepsia), Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, celiac disease, chronic constipation, chronic diarrhea, or gastrointestinal tract disorders or surgeries.
- •6. Anyone currently or recently (within the past 2 weeks) taking probiotic foods, including yoghurts.
- •7. Anyone currently or recently (within the last 12 weeks) taking medication, including proton pump inhibitors, anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, monoamine oxidase inhibitors (MAOIs), or thyroid products.
- •8. Currently partaking in another research study or will partake in any other research study for the next eight weeks or at any point during this study's duration.
研究组 & 干预措施
Limosilactobacillus reuteri DSM 17648
Experimental
Participant will take one capsule of L. reuteri DSM 17648 once per day with liquid during or immediately after the main meal, for 8 weeks.
干预措施: Limosilactobacillus reuteri DSM 17648 (Dietary Supplement)
Placebo
Placebo Comparator
Participant will take one capsule of placebo once per day with liquid during or immediately after the main meal, for 8 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks
时间窗: Baseline; 8 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG questionnaire comprises twelve questions in two domains, i.e. the acid reflux related symptom domain and dyspeptic symptom domain. The FSSG uses a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. Total FSSG score ranges from 0-48. Higher score indicates higher frequency.
次要结局
- Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 2 weeks(Baseline, 2 weeks)
- Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks(Baseline, 4 weeks)
- Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks(Baseline, 6 weeks)
- Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 2 weeks(Baseline, 2 weeks)
- Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks(Baseline, 4 weeks)
- Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks(Baseline, 6 weeks)
- Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks(Baseline, 8 weeks)
- Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 2 weeks(Baseline, 2 weeks)
- Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks(Baseline, 4 weeks)
- Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks(Baseline, 6 weeks)
- Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks(Baseline, 8 weeks)
- Frequency Scale for the Symptoms of GERD (FSSG) relief rate at 4 weeks(Baseline, Week 4)
- Frequency Scale for the Symptoms of GERD (FSSG) relief rate at 8 weeks(Baseline, Week 8)
- Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 2 weeks(Baseline, 2 weeks)
- Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 4 weeks(Baseline, 4 weeks)
- Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 6 weeks(Baseline, 6 weeks)
- Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 8 weeks(Baseline, 8 weeks)
- Change from baseline perceived stress, measured by Perceived Stress Scale, at 8 weeks(Baseline, 8 weeks)
- Change from baseline perceived stress, measured by Perceived Stress Scale, at 4 weeks(Baseline, 4 weeks)
- Number of participants with self-reported adverse events(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks)
研究者
研究点 (2)
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