NCT07439718招募中不适用
The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年2月23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
- 25
- 试验地点
- 1
- 主要终点
- Change in total bacterial abundance of the gut microbiota captured in small intestinal fluid after one-month intervention with a butyric acid-rich triglyceride oil
研究概览
简要总结
This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females aged 18 to 60 years, inclusive, at enrollment.
- •BMI of ≥18.5 but <30 kg/m
- •Healthy, as determined based on self-reported medical history.
- •No planned change in diet or medical interventions during the study.
- •Willing to collect fecal samples and retrieve sampling capsules from feces.
- •Able to understand and to sign a written informed consent prior to study enrollment.
- •Willing and able to comply with the requirements for participation in this study.
排除标准
- •Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).
- •Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.
- •History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.
- •History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.
- •Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.
- •Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.
- •Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.
- •History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.
- •Any concurrent cancer diagnosis, as reported by the participant.
- •Any cancer treatment within the past year, as reported by the participant.
- •History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.
- •Any cardiovascular, endocrine, renal, liver, or other chronic disease likely to affect motility (i.e. diabetes mellitus, concurrent biliary tract stones, kidney stones, etc.), as reported by the participant.
- •Antibacterial/antifungal therapy in the past 3 months prior to enrolment, as reported by the participant.
- •Use of any medications or supplements that could substantially alter gastrointestinal acidity, motor function, or microbiota (e.g. proton pump inhibitors, H2 receptor antagonists, opioids, prokinetics, anticholinergics, laxatives) in the past 4 weeks prior to enrollment, as reported by the participant.
- •Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.
- •Scheduled for an MRI at any time during the study duration. Potential participants may be eligible to participate once their MRI procedure is completed.
- •Females of childbearing age who are pregnant or lactating, as reported by the participant (should an X-ray be required for confirmation of capsule passage; a urine pregnancy test will be administered beforehand).
- •Alcohol intake higher than 2 servings per day over a week (for males), or more than 1 serving per day over a week (for females), as reported by the participant. A serving is 0.3 dl of strong alcohol, 1 dl of wine, or 3 dl of beer.
- •Currently participating in another interventional study.
- •Family or hierarchical relationships with the research team members.
研究组 & 干预措施
Interventional Product Arm - butyric acid-rich triglyceride oil
Experimental
Butyric acid-rich triglyceride oil, commercially available
干预措施: Oil (Dietary Supplement)
结局指标
主要结局
Change in total bacterial abundance of the gut microbiota captured in small intestinal fluid after one-month intervention with a butyric acid-rich triglyceride oil
时间窗: From Baseline (Day 1) through study completion (average duration: 36 days)
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
Change in total bacterial abundance of the gut microbiota captured in fecal samples after one-month intervention with a butyric acid-rich triglyceride oil
时间窗: From Baseline (Day 1) through study completion (average duration: 36 days)
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
次要结局
- Change in butyrate levels in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.(From Baseline (Day 1) to Day 8 (after first ingestion of IP))
- Change in absolute amount of various lipid classes (e.g. triglycerides, fatty acids, etc.) in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.(From Baseline (Day 1) to Day 8 (after first ingestion of IP))
- Change in butyrate levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.(Day 8 (before and after ingestion of IP))
- Change in ketone bodies levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.(Day 8 (before and after ingestion of IP))
- Change in total bacterial abundance of the microbiota of saliva after one-month intervention with butyric acid-rich triglyceride oil.(From Baseline (Day 1) through study completion (average duration: 36 days))
- Change in total GSRS scores after one-month intervention with butyric acid-rich triglyceride oil(From Baseline (Day 1) through study completion (average duration: 36 days))
- Change in GSRS scores in each of the 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation) after one-month intervention with butyric acid-rich triglyceride oil(From Baseline (Day 1) through study completion (average duration: 36 days))
- Change in the Bristol stool scale after one-month intervention with butyric acid-rich triglyceride oil(From Baseline (Day 1) through study completion (average duration: 36 days))
- Ease of retrieval of capsules based on participant feedback(From Baseline (Day 1) through study completion (average duration: 36 days))
研究者
研究点 (1)
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