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

University of Roehampton

Status: Active, not recruiting

Conditions: Healthy Subjects

Treatments: Dietary Supplement: Personalized prebiotic dietary Formulation 1; Dietary Supplement: Personalized prebiotic dietary Formulation 3; Dietary Supplement: Personalized prebiotic dietary Formulation 2

Study type: Interventional

Funder types: Other

Identifiers

NCT07350538

AKT

LSC 25/ 431

10169630 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups

Personalized prebiotic dietary Formulation 1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Personalized prebiotic dietary Formulation 1

Personalized prebiotic dietary Formulation 2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Personalized prebiotic dietary Formulation 2

Personalized prebiotic dietary Formulation 3

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Personalized prebiotic dietary Formulation 3