HealthyGutBrainGABANCT05698862
Mapping the Impact of Gut Microbiota on Brain and Behavior Through the Lens of GABA
A study testing Probiotic in people with Healthy, run by University of Reading at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 May 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading
Reading, RG6 6AH
About this study
Official title: Mapping the Impact of Gut Bacteria on Brain and Behaviour Through the Lens of GABA (GutBrainGABA)
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).
Read more
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:
- Does the population of gut bacteria capable of producing GABA modulate brain-based measures of GABA?
- 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.
Read the detailed description
This interventional trial will involve a double-blind placebo-controlled crossover trial structured in 4 appointments: week 0 (W0), week 4 (W4), week 8 (W8) and week 12 (W12). The study will therefore last 12 weeks, and will include a screening visit and 4 study visits.
The interventional study has a cross-over design, and participants will therefore be invited to consume both the active probiotic supplement and the placebo at different times. The probiotic supplement (Lactobacillus brevis) was chosen based on the ability to produce GABA in vitro (Monteagudo et al., 2022). The placebo will be maltodextrin The products will be provided as capsules and are identical in texture and appearance.
For participants to be considered compliant and therefore included in the study they will be require:
- to take the probiotic supplement or placebo at least 6 out of every 7 days of the trial for the week period;
- to provide faecal, blood and urine samples and to be tested with a battery involving behaviour and brain measures relating to GABA levels/activity and
- to complete a food diary using an online app once every 4 weeks.
As age and BMI are factors associated with significant variation in gut microbiota composition/brain and behaviour functioning, both study arms will be matched on these criteria.
All interested Individuals will be invited to complete an initial screening questionnaire, which includes questions related to a) the study inclusion criteria. Individuals who meet the study inclusion criteria will then be asked to complete b) an MRI contraindications questionnaire and, in absence of any MRI-related contraindications, they will be asked to c) complete a medical/lifestyle questionnaire to confirm the absence of any exclusion criteria.
Individuals who meet the inclusion criteria will be invited to attend a screening visit at the University of Reading for familiarisation with the procedures and for any clarification they might need. Participants will be provided with a sample collection kit (for faecal and urine sample collection), will be instructed on how to use it, and will be asked to track their diet using an online app (eNutri).
All study appointments will take place at the University of Reading. On the day of the study appointment, participants will be asked to provide a fresh faecal sample and spot urine sample (first morning urine), collected using the sample kit they were provided with at the screening visit. A venous blood sample (equal to 10ml/ 2tsp) will be collected by experienced and trained phlebotomists at the University of Reading. Participants will then undergo a neuroimaging battery, which will include structural magnetic resonance images, magnetic resonance spectroscopy (MRS) to quantify concentrations of GABA in determined regions of the brain, and functional magnetic resonance imaging to evaluate functional connectivity between brain areas. Participants will then complete a battery of GABA-dependent behavioural assays including a facial emotion recognition task, a motor learning task, and a tactile frequency discrimination task. Participants will then complete the Autism Spectrum Quotient (AQ), the State and Trait Anxiety Inventory (STAI), and the Centre for Epidemiological Studies Depression Scale (CES-D). Participants will complete this battery of tasks at each of the four study visits at W0, W4, W8 and W12.
At the end of visit 1 (W0), participants will be provided with either the probiotic OR placebo supplement to consume daily for the next 4 weeks, i.e. between study visits 1 and 2. At the end of visit 2 (W4), participants will not be provided with any supplements as they will enter their 4-week period of washout. At the end of visit 3 (W8), participants will be provided with either the probiotic OR placebo supplement to consume daily for the next 4 weeks. If the participant received the probiotic following visit 1, they will receive the placebo at this point, and vice versa. Participants will be asked to take this daily until their fourth and final study visit (W12). Study visit 4 finalises the study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants will be required to take a probiotic supplement of Lactobacillus brevis daily (1 capsule 5B CFU/day)
PlaceboDietary supplement
Participants will be required to take the placebo maltodextrin daily (1 capsule/day)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic supplement (Lactobacillus brevis) Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo (maltodextrin) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GABA concentrations in the brain assessed using Magnetic Resonance Spectroscopy (MRS)
Concentrations of GABA will be quantified using MRS. MRS data will be analysed separately in the time domain using an open-source magnetic resonance spectroscopy analysis tool, such as Osprey.
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in GABA-ergic activity in the sensorimotor component of the resting state network assessed using resting state functional Magnetic Resonance Imagine (rs-fMRI)
GABA-ergic activity will be measured using rs-fMRI. MRI data will be analysed..
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in GABA concentrations in urine assessed by Liquid chromatography-mass spectrometry (LC-MS).
Concentrations of GABA will be measured in urine samples by LC-MS.
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in GABA concentrations in serum assessed by Liquid chromatography-mass spectrometry (LC-MS).
Concentrations of GABA will be measured in serum samples by LC-MS.
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Secondary outcomes (11)
Changes in faecal bacteria quantity assessed by Fluorescent In Situ Hybridisation Followed by Flow Cytometry (FISH-FCM)
Quantity of faecal bacteria will be assessed by FISH-FCM
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in compositional diversity of faecal microbiota attributable to intervention assessed by 16S ribosomal RNA (16S rRNA) gene amplicon sequencing
Compositional diversity of faecal microbiota attributable to intervention will measured by 16S rRNA sequencing methods
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment)
Changes in metabolic profile in faecal samples assessed by Nuclear Magnetic Resonance spectroscopy (NMR)
The metabolic profile will be measured in faecal samples using NMR
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in metabolic profile in urine samples assessed by Nuclear Magnetic Resonance spectroscopy (NMR)
The metabolic profile will be measured in urine samples using NMR
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in metabolic profile in serum samples assessed by Nuclear Magnetic Resonance spectroscopy (NMR)
The metabolic profile will be measured in serum samples using NMR
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in blood pressure assessed by measures of systolic and diastolic blood pressure
Blood pressure will be recorded during the intervention using an upper arm blood pressure monitor
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in motor function performance assessed by reaction time
Motor performance data will be calculated by averaging the reaction time from correct trials (i.e., where participants pressed the button corresponding to the visual sequence presented).
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in emotion recognition performance assessed by reaction time and accuracy
Emotion recognition task accuracy and reaction time will be calculated in response to six emotions and a neutral facial expression.
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in tactile discrimination performance assessed by reaction time, static threshold and dynamic threshold
Tactile discrimination reaction time and thresholds will be obtained from each participant using established 'staircase' threshold estimation procedures.
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in levels of trait and state anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Trait and state levels of anxiety will be assessed by the STAI questionnaire
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in levels of depression assessed by the Centre for Epidemiological Studies Depression questionnaire (CES-D)
Levels of depression will be assessed by the CES-D questionnaire
Measured: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start21 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Principal investigator, Bhismadev Chakrabarti, University of Reading
- Investigators
- Bhismadev Chakrabarti, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698862
- Sponsor's protocol ID
- GBGABAWP2
- Acronym
- GutBrainGABA
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Impact of Gut Bacteria on Brain and Behaviour Through the Lens of GABA (GutBrainGABA)
- ClinicalTrials.gov ID
- NCT05698862
- Acronym / sponsor ID
- GutBrainGABA / GBGABAWP2
- Conditions
- Healthy
- Keywords
- Gamma Amino Butyric Acid (GABA), Brain function, Gut microbiota, Behaviour, Probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 21 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2023 (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.
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:
- Does the population of gut bacteria capable of producing GABA modulate brain-based measures of GABA?
- 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.
Detailed description
This interventional trial will involve a double-blind placebo-controlled crossover trial structured in 4 appointments: week 0 (W0), week 4 (W4), week 8 (W8) and week 12 (W12). The study will therefore last 12 weeks, and will include a screening visit and 4 study visits.
The interventional study has a cross-over design, and participants will therefore be invited to consume both the active probiotic supplement and the placebo at different times. The probiotic supplement (Lactobacillus brevis) was chosen based on the ability to produce GABA in vitro (Monteagudo et al., 2022). The placebo will be maltodextrin The products will be provided as capsules and are identical in texture and appearance.
For participants to be considered compliant and therefore included in the study they will be require:
- to take the probiotic supplement or placebo at least 6 out of every 7 days of the trial for the week period;
- to provide faecal, blood and urine samples and to be tested with a battery involving behaviour and brain measures relating to GABA levels/activity and
- to complete a food diary using an online app once every 4 weeks.
As age and BMI are factors associated with significant variation in gut microbiota composition/brain and behaviour functioning, both study arms will be matched on these criteria.
All interested Individuals will be invited to complete an initial screening questionnaire, which includes questions related to a) the study inclusion criteria. Individuals who meet the study inclusion criteria will then be asked to complete b) an MRI contraindications questionnaire and, in absence of any MRI-related contraindications, they will be asked to c) complete a medical/lifestyle questionnaire to confirm the absence of any exclusion criteria.
Individuals who meet the inclusion criteria will be invited to attend a screening visit at the University of Reading for familiarisation with the procedures and for any clarification they might need. Participants will be provided with a sample collection kit (for faecal and urine sample collection), will be instructed on how to use it, and will be asked to track their diet using an online app (eNutri).
All study appointments will take place at the University of Reading. On the day of the study appointment, participants will be asked to provide a fresh faecal sample and spot urine sample (first morning urine), collected using the sample kit they were provided with at the screening visit. A venous blood sample (equal to 10ml/ 2tsp) will be collected by experienced and trained phlebotomists at the University of Reading. Participants will then undergo a neuroimaging battery, which will include structural magnetic resonance images, magnetic resonance spectroscopy (MRS) to quantify concentrations of GABA in determined regions of the brain, and functional magnetic resonance imaging to evaluate functional connectivity between brain areas. Participants will then complete a battery of GABA-dependent behavioural assays including a facial emotion recognition task, a motor learning task, and a tactile frequency discrimination task. Participants will then complete the Autism Spectrum Quotient (AQ), the State and Trait Anxiety Inventory (STAI), and the Centre for Epidemiological Studies Depression Scale (CES-D). Participants will complete this battery of tasks at each of the four study visits at W0, W4, W8 and W12.
At the end of visit 1 (W0), participants will be provided with either the probiotic OR placebo supplement to consume daily for the next 4 weeks, i.e. between study visits 1 and 2. At the end of visit 2 (W4), participants will not be provided with any supplements as they will enter their 4-week period of washout. At the end of visit 3 (W8), participants will be provided with either the probiotic OR placebo supplement to consume daily for the next 4 weeks. If the participant received the probiotic following visit 1, they will receive the placebo at this point, and vice versa. Participants will be asked to take this daily until their fourth and final study visit (W12). Study visit 4 finalises the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticProbiotic supplement (Lactobacillus brevis) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (maltodextrin) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Right-handed
- Caucasian/White
- Between 18 and 50 years of age
- Grew up in the UK or other European country
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| ProbioticParticipants will be required to take a probiotic supplement of Lactobacillus brevis daily (1 capsule 5B CFU/day) | Dietary supplement | Probiotic |
| PlaceboParticipants will be required to take the placebo maltodextrin daily (1 capsule/day) | Dietary supplement | Placebo |
Primary outcome
Changes in GABA concentrations in the brain assessed using Magnetic Resonance Spectroscopy (MRS)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Concentrations of GABA will be quantified using MRS. MRS data will be analysed separately in the time domain using an open-source magnetic resonance spectroscopy analysis tool, such as Osprey.
Changes in GABA-ergic activity in the sensorimotor component of the resting state network assessed using resting state functional Magnetic Resonance Imagine (rs-fMRI)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
GABA-ergic activity will be measured using rs-fMRI. MRI data will be analysed..
Changes in GABA concentrations in urine assessed by Liquid chromatography-mass spectrometry (LC-MS).
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Concentrations of GABA will be measured in urine samples by LC-MS.
Changes in GABA concentrations in serum assessed by Liquid chromatography-mass spectrometry (LC-MS).
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Concentrations of GABA will be measured in serum samples by LC-MS.
11 secondary outcomes
Changes in faecal bacteria quantity assessed by Fluorescent In Situ Hybridisation Followed by Flow Cytometry (FISH-FCM)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in compositional diversity of faecal microbiota attributable to intervention assessed by 16S ribosomal RNA (16S rRNA) gene amplicon sequencing
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment)
Changes in metabolic profile in faecal samples assessed by Nuclear Magnetic Resonance spectroscopy (NMR)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in metabolic profile in urine samples assessed by Nuclear Magnetic Resonance spectroscopy (NMR)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in metabolic profile in serum samples assessed by Nuclear Magnetic Resonance spectroscopy (NMR)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in blood pressure assessed by measures of systolic and diastolic blood pressure
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in motor function performance assessed by reaction time
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in emotion recognition performance assessed by reaction time and accuracy
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in tactile discrimination performance assessed by reaction time, static threshold and dynamic threshold
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in levels of trait and state anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Changes in levels of depression assessed by the Centre for Epidemiological Studies Depression questionnaire (CES-D)
Time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Bhismadev Chakrabarti, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy, run by University of Reading 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 6 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: looking for participants now, as of the sponsor's last update on 26 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bhismadev chakrabarti, PhD (+44 118 378 5551, b.chakrabarti@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in GABA concentrations in the brain assessed using Magnetic Resonance Spectroscopy (MRS) (time frame: 1. Baseline (Week 0), 2. Following intervention (Week 4 or Week 12, depending on intervention arm assignment), 3. Following washout (Week 8), 4. Following placebo (Week 4 or Week 12, depending on intervention arm assignment)). The study lists 4 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 26 Jan 2023.