NCT07453823招募中不适用
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight: a Randomized, Double-blind, Placebo-controlled Study
Chr Hansen - part of Novonesis1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年3月18日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Bifidobacterium abundance
研究概览
简要总结
The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.
The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quardrople
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to give informed consent.
- •Be between 50 to 70 years of age (inclusive).
- •BMI ranging from 25.0 and 35.0 kg/m²
- •Willing to maintain current level of physical activity and diet during the participation in the study.
- •Experience ≤3 bowel movements per week within the month prior to screening
- •Participants reported subclinical mild to moderate gastrointestinal complaints as defined by GSRS-IBS score 20-45 at screening.
- •Willing to consume the study product daily for the duration of the study.
- •Willing to eat the same meal the evening before visiting site (visit 2 to visit 5).
- •Participants are eligible for randomization if they fulfill the following two criteria based on the diary recordings during the run-in period prior to visit 2
- •Average GSRS-IBS composite symptom score between 20-45 during the two-week run-in period Record ≤6 bowel movements in the daily diary during the two-week run-in period
排除标准
- •Has a history of drug and/or alcohol abuse.
- •Has food allergies, or other issues with foods, that would preclude intake of the study products.
- •Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.
- •Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
- •diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS)
- •GI surgery that might have an effect on gastrointestinal tract function except cholecystectomy and appendectomy in the past 5 years or any major bowel resection at any time.
- •history of CVD
- •uncontrolled hypertension
- •Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- •systemic antimicrobial medication (including suppositories) within 4 weeks prior to visit 1
- •OTC medications, for digestive symptoms such as PPIs, anti-spasmodics, laxatives, anti-diarrheic drugs within 2 weeks prior to visit 1
- •10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •11. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
- •c. immunosuppressant drugs within the 4 weeks prior to the visit 1 d. systemic steroids within the 4 weeks prior to the visit 1
- •Regular oral non-steroidal anti-inflammatory (NSAIDs) within 1 week prior to visit 1 (topical NSAIDS allowed, Low-dose prophylactic aspirin use is acceptable if stable for 3 months prior to screening.)
- •Current or recent (in the past 4 weeks prior to visit 1) use of prohibited nutritional and non-nutritional supplements, that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, including:
- •a. Herbal supplements for digestive symptoms b. Large doses of vitamins and minerals, unless in stable dose c. Probiotic supplements d. Iron supplements
- •Current or recent (in the past 2-weeks) use of prohibited foods including yoghurts containing probiotics.
- •9. Planned major changes in lifestyle [i.e., diet (e.g. start of fibre-enriched diet), dieting, exercise level, travelling] during the duration of the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Identical looking placebo consisting of maltodextrin
干预措施: Placebo (Dietary Supplement)
Synbiotic
Active Comparator
Synbiotic dietary supplement
干预措施: Synbiotic (Dietary Supplement)
结局指标
主要结局
Bifidobacterium abundance
时间窗: From baseline to end of intervention at 8 weeks
Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing.
次要结局
- Stool frequency(From baseline to end of intervention at 8 weeks)
- Fecal acetate(From baseline to end of intervention at 8 weeks.)
- Fecal propionate(From baseline to end of intervention at 8 weeks.)
- Fecal butyrate(From baseline to end of intervention at 8 weeks)
- Zonulin(From baseline to end of intervention at 8 weeks)
- Lipopolysaccharide binding protein (LPS-BP)(From baseline to end of intervention at 8 weeks)
- Interleukin 6 (IL-6)(From baseline to end of intervention at 8 weeks)
- High-sensitivity C-Reactive Protein (hsCRP)(From baseline to end of intervention at 8 weeks)
- Fecal Short-Chain Fatty Acids (SCFA)(From baseline to end of intervention at 8 weeks)
- Stool consistency(From baseline to end of intervention at 8 weeks)
- Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score(From baseline to end of intervention at 8 weeks)
研究者
研究点 (1)
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