NCT07350538

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Roehampton · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

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).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Personalized prebiotic dietary Formulation 2	Vitamin K Vitamin B1 Tryptophan Vitamin B6 Vitamin B5 Vitamin B9 Vitamin B3 Alpha-arabinooligosaccharides Ribose
DIETARY_SUPPLEMENT	Personalized prebiotic dietary Formulation 3	Lipoate Vitamin B9 Beta-glucosides Vitamin B5 Vitamin B7 Vitamin B6 Vitamin K Galactooligosaccharides Oligogalacturonate, Rhamnogalacturonides Fructooligosaccharides
DIETARY_SUPPLEMENT	Personalized prebiotic dietary Formulation 1	Chitobiose, Beta-glucosides Xylooligosaccharide Alpha-arabinooligosaccharides Fructooligosaccharides Ribose Oligogalacturonate, Rhamnogalacturonides

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-01-12
• Completion: 2026-06-15
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: United Kingdom