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

NCT07350538 | Active Not Recruiting DMC

• 3 other identifiers: LSC 25/ 431AKT10169630
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Neurocognitive Performance - Attention

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

• Neurocognitive Performance - Inhibitory Control

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

• Self-Reported Mood and Psychological State

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

Study Arms (3)

Personalized prebiotic dietary Formulation 1

ACTIVE COMPARATOR

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

Dietary Supplement: Personalized prebiotic dietary Formulation 1

Personalized prebiotic dietary Formulation 2

ACTIVE COMPARATOR

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

Dietary Supplement: Personalized prebiotic dietary Formulation 2

Personalized prebiotic dietary Formulation 3

ACTIVE COMPARATOR

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

Dietary Supplement: Personalized prebiotic dietary Formulation 3

Interventions

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 2

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 3

Personalized prebiotic dietary Formulation 1 DIETARY_SUPPLEMENT

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

Personalized prebiotic dietary Formulation 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

University of Roehampton, School of Life and Health Sciences

London, UK, SW15 4JD, United Kingdom

Location

Study Officials

• ADELE COSTABILE

  University of Roehampton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Following baseline analysis, each participant will receive a personalized prebiotic dietary formulation 1 or 2 or 3 as reported below (a nutritional supplement tailored to their microbiome profile as) to take daily for 60 days
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Model Details: Prospective interventional prebiotic pilot dietary clinical study

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 20, 2026
• Study Start: December 10, 2025
• Primary Completion: January 12, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)