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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Personalized prebiotic dietary Formulation 1; Dietary supplement: Personalized prebiotic dietary Formulation 2; Dietary supplement: Personalized prebiotic dietary Formulation 3

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • UK
    • London, UK, United Kingdom, SW15 4JD
      • University of Roehampton, School of Life and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Personalized prebiotic dietary Formulation 1; A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days	Dietary supplement: Personalized prebiotic dietary Formulation 1; Chitobiose, Beta-glucosides Xylooligosaccharide Alpha-arabinooligosaccharides Fructooligosaccharides Ribose Oligogalacturonate, Rhamnogalacturonides
Active Comparator: Personalized prebiotic dietary Formulation 2; A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days	Dietary supplement: Personalized prebiotic dietary Formulation 2; Vitamin K Vitamin B1 Tryptophan Vitamin B6 Vitamin B5 Vitamin B9 Vitamin B3 Alpha-arabinooligosaccharides Ribose
Active Comparator: Personalized prebiotic dietary Formulation 3; A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days	Dietary supplement: Personalized prebiotic dietary Formulation 3; Lipoate Vitamin B9 Beta-glucosides Vitamin B5 Vitamin B7 Vitamin B6 Vitamin K Galactooligosaccharides Oligogalacturonate, Rhamnogalacturonides Fructooligosaccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiome Taxonomic Composition	Change from baseline to Day 60 in gut microbiome taxonomic composition, measured as relative abundance of bacterial taxa from stool samples expressed as %	Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Microbial Functional Capacity - Fiber Fermentation	Change from baseline to Day 60 in predicted fiber fermentation capacity of the gut microbiome.Functional capacity score (arbitrary units derived from DynaMAP™ analysis)	Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Microbial Functional Capacity - Short-Chain Fatty Acid (SCFA) Production Potential	Change from baseline to Day 60 in predicted SCFA production potential of the gut microbiome in mmol/L	Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive Performance - Attention	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)	Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Neurocognitive Performance - Inhibitory Control	Change from baseline to Day 60 in inhibitory control performance. Task-based performance metrics	Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Self-Reported Mood and Psychological State	Change from baseline to Day 60 in self-reported mood and psychological state, assessed via validated questionnaires administered through Qualtrics.	Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)

Collaborators and Investigators

• Sponsor: University of Roehampton
• Investigators: Study Director: ADELE COSTABILE, University of Roehampton

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Actual): January 12, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LSC 25/ 431; AKT (Other Grant/Funding Number: UKRI); 10169630 (Other Grant/Funding Number: UKRI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No