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

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).

• 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

• Gut Microbiome Taxonomic Composition [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 [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 [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

• Neurocognitive Performance - Attention [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)
• Neurocognitive Performance - Inhibitory Control [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
• Self-Reported Mood and Psychological State [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.

Sex: All, ages: 18 Years to 65 Years, 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

• ADELE COSTABILE, Study director, University of Roehampton