Healthy SubjectsRECLAIM-GUTNCT07350538
The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL
A study testing Personalized prebiotic dietary Formulation 2, Personalized prebiotic dietary Formulation 3 and Personalized prebiotic dietary Formulation 1 in people with Healthy Subjects, run by University of Roehampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Personalized prebiotic dietary Formulation 2, Personalized prebiotic dietary Formulation 3 and Personalized prebiotic dietary Formulation 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Roehampton, School of Life and Health Sciences
London, UK, SW15 4JD
About this study
Official title: 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.
Read the 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
- Being tested
- Personalized prebiotic dietary Formulation 2, Personalized prebiotic dietary Formulation 3, Personalized prebiotic dietary Formulation 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized prebiotic dietary Formulation 2Dietary supplement
Vitamin K Vitamin B1 Tryptophan Vitamin B6 Vitamin B5 Vitamin B9 Vitamin B3 Alpha-arabinooligosaccharides Ribose
Personalized prebiotic dietary Formulation 3Dietary supplement
Lipoate Vitamin B9 Beta-glucosides Vitamin B5 Vitamin B7 Vitamin B6 Vitamin K Galactooligosaccharides Oligogalacturonate, Rhamnogalacturonides Fructooligosaccharides
Personalized prebiotic dietary Formulation 1Dietary supplement
Chitobiose, Beta-glucosides Xylooligosaccharide Alpha-arabinooligosaccharides Fructooligosaccharides Ribose Oligogalacturonate, Rhamnogalacturonides
| Study group | Role | What they receive |
|---|---|---|
| Personalized prebiotic dietary Formulation 1 | Active comparator | A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days Receives: 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 Receives: 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 Receives: Dietary Supplement: Personalized prebiotic dietary Formulation 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %
Measured: 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)
Measured: 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
Measured: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Secondary outcomes (3)
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)
Measured: 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
Measured: 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.
Measured: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start10 Dec 2025
- Primary completion12 Jan 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective interventional prebiotic pilot dietary clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ADELE COSTABILE, University of Roehampton
- Investigators
- ADELE COSTABILE, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350538
- Sponsor's protocol ID
- LSC 25/ 431
- Other IDs
- AKT, 10169630
- Acronym
- RECLAIM-GUT
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Exploratory Investigation Into DynaMAP Validation, Gut Microbiome Profiling, and Personalized Prebiotic Interventions for Alcohol Addiction Recovery
- ClinicalTrials.gov ID
- NCT07350538
- Acronym / sponsor ID
- RECLAIM-GUT / LSC 25/ 431
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective interventional prebiotic pilot dietary clinical study
| Arm | Type | Receives |
|---|---|---|
| Personalized prebiotic dietary Formulation 1 | Active comparator | Dietary Supplement: Personalized prebiotic dietary Formulation 1A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days |
| Personalized prebiotic dietary Formulation 2 | Active comparator | Dietary Supplement: Personalized prebiotic dietary Formulation 2A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days |
| Personalized prebiotic dietary Formulation 3 | Active comparator | Dietary Supplement: Personalized prebiotic dietary Formulation 3A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized prebiotic dietary Formulation 2Vitamin K Vitamin B1 Tryptophan Vitamin B6 Vitamin B5 Vitamin B9 Vitamin B3 Alpha-arabinooligosaccharides Ribose | Dietary supplement | Personalized prebiotic dietary Formulation 2 |
| Personalized prebiotic dietary Formulation 3Lipoate Vitamin B9 Beta-glucosides Vitamin B5 Vitamin B7 Vitamin B6 Vitamin K Galactooligosaccharides Oligogalacturonate, Rhamnogalacturonides Fructooligosaccharides | Dietary supplement | Personalized prebiotic dietary Formulation 3 |
| Personalized prebiotic dietary Formulation 1Chitobiose, Beta-glucosides Xylooligosaccharide Alpha-arabinooligosaccharides Fructooligosaccharides Ribose Oligogalacturonate, Rhamnogalacturonides | Dietary supplement | Personalized prebiotic dietary Formulation 1 |
Primary outcome
Gut Microbiome Taxonomic Composition
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
Neurocognitive Performance - Attention
Time frame: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Neurocognitive Performance - Inhibitory Control
Time frame: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Self-Reported Mood and Psychological State
Time frame: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADELE COSTABILE study director
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized prebiotic dietary Formulation 2, Personalized prebiotic dietary Formulation 3 and Personalized prebiotic dietary Formulation 1 in people with Healthy Subjects, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Taxonomic Composition (time frame: Baseline (Day 0) and Day 60 (end of prebiotic supplementation period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.