NCT05698862 Mapping the Impact of Gut Microbiota on Brain and Behavior Through the Lens of GABA
| NCT ID | NCT05698862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Reading |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-05-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Gut microbiota produce different metabolites within the human body, which include neurotransmitters. Animal studies have demonstrated a critical role for the gut microbiota in various aspects of brain and behavioural function, and a smaller number of studies in humans have shown differences of gut microbiota composition in psychiatric conditions. However, almost nothing is known about the impact of neurotransmitters produced by the gut microbiota on human brain and behaviour. The way in which differences in brain, behaviour and personality traits are associated with the gut microbiota, and how they are influenced by a probiotic will be explored, with a special focus on GABA (Gamma Amino Butyric Acid). Abnormalities of microbiota composition have been identified in metabolic disorders, such as inflammatory bowel disease and obesity, and psychiatric conditions, such as depression and anxiety. The aim of this intervention trial will be to answer the following fundamental questions: 1. Does the population of gut bacteria capable of producing GABA modulate brain-based measures of GABA? 2. Does the population of gut bacteria capable of producing GABA influence performance in behavioural tasks known to depend on GABA-ergic function? The impact of a GABA producing probiotic on the measures of GABA in the brain and serum, relevant metabolites in blood, faecal and urine samples and performance in GABA dependent behavioural tasks will be investigated in this trial.
Eligibility Criteria
Inclusion Criteria: * Male * Right-handed * Caucasian/White * Between 18 and 50 years of age * Grew up in the UK or other European country * Body Mass Index 18.5 to 30. Exclusion Criteria: * Use of antibiotics within the last 3 months * Use of protonic pump inhibitors (PPIs) within the last 3 months * Current or history of regular smoking within the last 6 months * Regular consumption of \>14 units of alcohol per week * Current use of psychotropic drugs for medicinal or recreational purposes * Current use of probiotic/prebiotic supplements * Current diagnosis of neurological, developmental or psychiatric condition * Current diagnosis of gut microbiota related conditions such as inflammatory bowel disease or irritable bowel syndrome
Contact & Investigator
Bhismadev Chakrabarti, PhD
PRINCIPAL INVESTIGATOR
University of Reading
Frequently Asked Questions
Who can join the NCT05698862 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05698862 currently recruiting?
Yes, NCT05698862 is actively recruiting participants. Contact the research team at b.chakrabarti@reading.ac.uk for enrollment information.
Where is the NCT05698862 trial being conducted?
This trial is being conducted at Reading, United Kingdom.
Who is sponsoring the NCT05698862 clinical trial?
NCT05698862 is sponsored by University of Reading. The principal investigator is Bhismadev Chakrabarti, PhD at University of Reading. The trial plans to enroll 60 participants.