Early Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Stool metagenome
研究概览
简要总结
This study is a pre-post, open-label pilot feasibility study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for 1 month. During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers.
This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease.
详细描述
Participants self-administer one capsule of 1C-01 daily for 28 days. 1C-01 is a live-culture food supplement.
Biological sampling occurs at two timepoints, baseline and end of intervention. Venous blood is drawn at the participant's home by a trained healthcare assistant employed by the sponsor. Stool is self-collected by the participant using a supplied kit and transported by study staff. Stool undergoes shotgun metagenomic sequencing; plasma undergoes untargeted metabolomic and proteomic profiling. Samples are rendered acellular on receipt and held at the sponsor's primary site.
Remote assessments are delivered through a browser-based study application and are completed together in a single session at baseline and at scheduled fortnightly intervals thereafter. Each session comprises the seven-task cognitive battery, the sleep questionnaire, the mood and stress ratings, and the adherence record for the preceding interval. The cognitive battery is modelled on the UK Biobank assessments using original task content; trial-level response data are retained alongside summary scores. The exit questionnaire is presented once, at the end of the intervention period.
The study is conducted in a hybrid format, with remote assessment and in-person sample collection at participants' homes.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50 years or older at the time of providing informed consent.
- •Stable medical conditions are permitted provided they are not psychiatric or neurological in nature and are not known to interfere with the aims of the study, participant safety, or patient ability to consent.
- •No history of significant psychiatric or neurological illness
- •Ability to complete study specific tasks, including:
- •Daily oral intake of a probiotic capsule
- •Self-collection of stool samples
- •Completion of online questionnaires and simple cognitive tasks
- •Able to read, understand, and communicate in English, in order to give informed consent and follow study instructions.
- •Access to the internet and a suitable device (e.g., smartphone, tablet, or computer) for completing online aspects of the study.
排除标准
- •Previous use of the study probiotic (1C-01) as individuals who have previously taken 1C-01 are not eligible.
- •Use of any systemic antibiotic or systemic immunosuppressive medication within the past 8 weeks, including but not limited to:
- •β-lactam antibiotics, macrolides, tetracyclines, fluoroquinolones, aminoglycosides, glycopeptides, sulfonamides, antimycobacterial agents, systemic antifungals or antivirals
- •Use of any systemic immunosuppressants within the past 16 weeks, including, but not limited to:
- •Systemic corticosteroids, conventional immunosuppressants, biologic immunomodulators, targeted synthetic immunosuppressants, cytotoxic chemotherapy, or transplant-related immunosuppression.
- •A longer exclusion window is applied for systemic immunosuppressive therapies due to their prolonged and potentially lasting effects on immune function and gut microbial composition compared with systemic antibiotics.
- •Participants who commence systemic antibiotics or immunosuppressive therapy after enrolment will not be withdrawn from safety monitoring but will stop the supplement and will not continue the intervention phase of the study. With participant consent, data collected may still be used.
- •Major gastrointestinal disease or surgery:
- •Any history of significant gastrointestinal disease or surgery that may alter gut microbiome composition, immune function, or nutrient absorption, including but not limited to inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis); coeliac disease or other chronic malabsorptive disorders; chronic liver, biliary, or pancreatic disease; moderate-to-severe or unstable irritable bowel syndrome; gastrointestinal malignancy; chronic gastrointestinal motility disorders; recurrent Clostridioides difficile infection; or any major gastrointestinal surgery such as bowel resection, bariatric surgery, colectomy, ileostomy or colostomy. Prior appendectomy or cholecystectomy alone is not exclusionary.
- •Women of child-bearing potential (WOCBP). Women of non-child-bearing potential (WONCBP) are eligible; for the purposes of this study, WONCBP is defined as post-menopausal, i.e. no menstrual period for ≥12 consecutive months with no alternative medical cause. Breastfeeding women are also excluded.
- •Known allergy to probiotic or compounding ingredients:
- •Vitamin D3
- •Isomaltooligosaccharide
- •Yeast extract
研究组 & 干预措施
Intervention Group
4 week course of 1C-01
干预措施: Probiotic Supplement (1C-01) (Dietary Supplement)
结局指标
主要结局
Stool metagenome
时间窗: From enrolment to end of treatment at 4 weeks
Change from baseline in stool metagenomic markers, representing stool microbiome.
次要结局
- Plasma Metabolome, Proteome(From enrolment to end of treatment at 4 weeks)
- Cognitive Task Performance(From enrolment to end of treatment at 4 weeks.)
- Self-reported Sleep(From enrolment to end of treatment at 4 weeks.)
- Wellbeing(Enrolment to end of treatment at 4 weeks.)
- Adherence(Enrolment to end of treatment at 4 weeks.)
- Adverse Events(Enrolment to end of treatment at 4 weeks.)
- Acceptability of study procedures(Assessed at week 4 (end of treatment))