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Active, Not Recruiting

NCT Number: NCT07350538

The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Roehampton, School of Life and Health Sciences

London, UK, SW15 4JD, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Personalized prebiotic dietary Formulation 2

Dietary Supplement

Vitamin K Vitamin B1 Tryptophan Vitamin B6 Vitamin B5 Vitamin B9 Vitamin B3 Alpha-arabinooligosaccharides Ribose

Personalized prebiotic dietary Formulation 3

Dietary Supplement

Lipoate Vitamin B9 Beta-glucosides Vitamin B5 Vitamin B7 Vitamin B6 Vitamin K Galactooligosaccharides Oligogalacturonate, Rhamnogalacturonides Fructooligosaccharides

Personalized prebiotic dietary Formulation 1

Dietary Supplement

Chitobiose, Beta-glucosides Xylooligosaccharide Alpha-arabinooligosaccharides Fructooligosaccharides Ribose Oligogalacturonate, Rhamnogalacturonides

Primary outcomes

  1. Gut Microbiome Taxonomic Composition

    Time frame: 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 %

  2. Microbial Functional Capacity - Fiber Fermentation

    Time frame: 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)

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

    Time frame: 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

Secondary outcomes

  1. Neurocognitive Performance - Attention

    Time frame: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

    Change from baseline to Day 60 in attention performance, assessed using standardized computerized cognitive tasks administered via Inquisit.Task-based performance metrics (e.g., reaction time in milliseconds)

  2. Neurocognitive Performance - Inhibitory Control

    Time frame: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

    Change from baseline to Day 60 in inhibitory control performance. Task-based performance metrics

  3. Self-Reported Mood and Psychological State

    Time frame: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

    Change from baseline to Day 60 in self-reported mood and psychological state, assessed via validated questionnaires administered through Qualtrics.

Sponsors and collaborators

Lead sponsor

University of Roehampton

Other

Registry information

Official study title

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

Acronym: RECLAIM-GUT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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