MedTrace Logo

Mapping the Impact of Gut Microbiota on Brain and Behavior Through the Lens of GABA

NCT05698862 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-26

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Probiotic

Participants will be required to take a probiotic supplement of Lactobacillus brevis daily (1 capsule 5B CFU/day)

DIETARY_SUPPLEMENT

Placebo

Participants will be required to take the placebo maltodextrin daily (1 capsule/day)

Sponsors & Collaborators

Principal Investigators

  • Bhismadev Chakrabarti, PhD · University of Reading

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-21
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698862 on ClinicalTrials.gov