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| ID | Type | Description | Link |
|---|---|---|---|
| AKT | Other Grant/Funding Number | UKRI | |
| 10169630 | Other Grant/Funding Number | UKRI |
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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' DynaMAPâ„¢ technology enables strain-level microbiome profiling. This study aims to validate DynaMAPâ„¢ against shotgun metagenomic sequencing and assess personalized prebiotic interventions based on individual microbiome profiles.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized prebiotic dietary Formulation 1 | Active Comparator | A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days |
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| Personalized prebiotic dietary Formulation 2 | Active Comparator | A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days |
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| Personalized prebiotic dietary Formulation 3 | Active Comparator | A nutritional prebiotic supplement tailored to their microbiome profile as to take daily for 60 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized prebiotic dietary Formulation 2 | Dietary Supplement | Vitamin K Vitamin B1 Tryptophan Vitamin B6 Vitamin B5 Vitamin B9 Vitamin B3 Alpha-arabinooligosaccharides Ribose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 DynaMAPâ„¢ 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (Day 0) and Day 60 (end of prebiotic supplementation period) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ADELE COSTABILE | University of Roehampton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Roehampton, School of Life and Health Sciences | London | UK | SW15 4JD | United Kingdom |
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Prospective interventional prebiotic pilot dietary clinical study
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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
| Personalized prebiotic dietary Formulation 3 | Dietary Supplement | Lipoate Vitamin B9 Beta-glucosides Vitamin B5 Vitamin B7 Vitamin B6 Vitamin K Galactooligosaccharides Oligogalacturonate, Rhamnogalacturonides Fructooligosaccharides |
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| Personalized prebiotic dietary Formulation 1 | Dietary Supplement | Chitobiose, Beta-glucosides Xylooligosaccharide Alpha-arabinooligosaccharides Fructooligosaccharides Ribose Oligogalacturonate, Rhamnogalacturonides |
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| Neurocognitive Performance - Inhibitory Control |
Change from baseline to Day 60 in inhibitory control performance. Task-based performance metrics |
| 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. | Baseline (Day 0) and Day 60 (end of prebiotic supplementation period) |