跳至主要内容
临床试验/NCT07350538
NCT07350538进行中(未招募)不适用

Pilot Exploratory Investigation Into DynaMAP Validation, Gut Microbiome Profiling, and Personalized Prebiotic Interventions for Alcohol Addiction Recovery

University of Roehampton1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
Gut Microbiome Taxonomic Composition

研究概览

简要总结

The human gut contains a vast community of microorganisms-including bacteria, viruses, and fungi-collectively known as the gut microbiota. This ecosystem co-evolves with humans and is shaped by diet, environment, and lifestyle. A balanced microbiota is essential for health, supporting immune function, regulating metabolism, and controlling intestinal inflammation. When this balance, or homeostasis, is disrupted, dysbiosis can occur, which has been linked to conditions such as inflammatory bowel disease, obesity, type 2 diabetes, cardiovascular disease, cancers, and neurological disorders. Evidence also shows that substance abuse can induce dysbiosis by altering microbial diversity, disrupting microbial composition, and reducing levels of key metabolites like short-chain fatty acids. Growing research on the gut-brain axis suggests that these microbial imbalances may influence mental health by affecting neurochemical signalling, contributing to disorders such as depression and anxiety. While synthetic drugs remain central to modern medicine and provide targeted, effective treatments, they often fall short when illnesses stem from disturbances within the microbial ecosystem. Because many conditions related to gut dysbiosis are not caused by a single malfunctioning molecule, traditional drugs may manage symptoms without restoring microbial balance. Some treatments, particularly broad-spectrum antibiotics, may even exacerbate dysbiosis by eliminating beneficial microbes. This has led to increasing interest in probiotics, prebiotics, and postbiotics. Probiotics are beneficial live microbes, prebiotics are non-digestible compounds that help these microbes grow, and postbiotics are their health-promoting byproducts. Although promising, these interventions are still considered supplements rather than formal medicines. Studying stool samples allows researchers to assess gut health by measuring bacterial and metabolic contents. Advances in this field require precise, efficient tools. Perseus Biomics' DynaMAP™ technology enables strain-level microbiome profiling. This study aims to validate DynaMAP™ against shotgun metagenomic sequencing and assess personalized prebiotic interventions based on individual microbiome profiles.

详细描述

A 60-day prospective, single-arm interventional pilot trial study in healthy adults who use alcohol moderately (6pints per week). A total of 20 participants will be invited to take part in this study. Open-label design (no blinding) since all participants will receive an active intervention (a personalized prebiotic) and there is no placebo/control group. The design features two main components within the same cohort: (1) a cross-sectional methodological comparison at baseline (comparing two lab methods on the same samples), and (2) a longitudinal intervention assessment (pre- vs post- supplementation within subjects).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Following baseline analysis, each participant will receive a personalized prebiotic dietary formulation 1 or 2 or 3 as reported below (a nutritional supplement tailored to their microbiome profile as) to take daily for 60 days

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged approximately 18-65 years
  • Male or female
  • Generally in good health, with no significant chronic illnesses
  • Resident in the UK (to enable centralized ethics oversight and logistics)
  • Able to re and understand English (for e-consent and study instructions)
  • Mild to moderate alcohol consumption (more than 14 units or 6 pints per week)
  • Willing to provide stool samples at the required time points
  • Willing to take a daily prebiotic supplement for 60 days
  • Has access to the internet and email for remote communication
  • Able and willing to provide informed electronic consent

排除标准

  • Any known significant gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
  • Any major medical condition that could affect the gut microbiome or pose a health risk (e.g., immunocompromised conditions)
  • Recent use of antibiotics (within the past 2-3 months)
  • Recent regular use of probiotics or prebiotics (within approximately the past 4 weeks)
  • Pregnant or breastfeeding women (pregnancy will be screened at enrolment, as the intervention is not tested during pregnancy and pregnancy itself alters the gut microbiome)
  • Known allergies or intolerances to components likely used in the prebiotic formulation (e.g., certain amino acids)
  • Use of special diets or medications that significantly alter gut microbiota (e.g., chronic laxative use, immunosuppressive therapy)
  • Participation in another interventional clinical trial within the past 3 months

研究组 & 干预措施

Personalized prebiotic dietary Formulation 1

Active Comparator

A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days

干预措施: Personalized prebiotic dietary Formulation 1 (Dietary Supplement)

Personalized prebiotic dietary Formulation 2

Active Comparator

A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days

干预措施: Personalized prebiotic dietary Formulation 2 (Dietary Supplement)

Personalized prebiotic dietary Formulation 3

Active Comparator

A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days

干预措施: Personalized prebiotic dietary Formulation 3 (Dietary Supplement)

结局指标

主要结局

Gut Microbiome Taxonomic Composition

时间窗: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

Change from baseline to Day 60 in gut microbiome taxonomic composition, measured as relative abundance of bacterial taxa from stool samples expressed as %

Microbial Functional Capacity - Fiber Fermentation

时间窗: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

Change from baseline to Day 60 in predicted fiber fermentation capacity of the gut microbiome.Functional capacity score (arbitrary units derived from DynaMAP™ analysis)

Microbial Functional Capacity - Short-Chain Fatty Acid (SCFA) Production Potential

时间窗: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

Change from baseline to Day 60 in predicted SCFA production potential of the gut microbiome in mmol/L

次要结局

  • Neurocognitive Performance - Attention(Baseline (Day 0) and Day 60 (end of prebiotic supplementation period))
  • Neurocognitive Performance - Inhibitory Control(Baseline (Day 0) and Day 60 (end of prebiotic supplementation period))
  • Self-Reported Mood and Psychological State(Baseline (Day 0) and Day 60 (end of prebiotic supplementation period))

研究者

发起方
University of Roehampton
申办方类型
Other
责任方
Principal Investigator
主要研究者

DR ADELE COSTABILE

Director, Principal Investigator, Clinical Professor

University of Roehampton

研究点 (1)

Loading locations...

相似试验