Healthy AdultNCT07504952
Investigating the Impact of Probiotics on Wellbeing in a Community
A study testing Probiotic Arm in people with Healthy Adult, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The aim of this clinical trial is to investigate whether taking probiotics can improve thinking ability and digestive symptoms in healthy adults, and whether these effects depend on how often someone drinks alcohol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Probiotic Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Sep 2025to 1 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants under 18 years of age
- Regular use of probiotics or prebiotics (in supplements or foods) within the past 4 weeks
- Antibiotic use within the past 4 weeks
- Chronic gastrointestinal disorders (e.g. Irritable Bowel Syndrome, Crohn's disease, etc)
- Major psychiatric conditions diagnosed (e.g., bipolar disorder, schizophrenia, etc)
- Current pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Alcohol Consumption Moderate the Effects of Probiotic Supplementation on Cognitive and Gastrointestinal Outcomes in a Non-clinical Sample?
The aim of this clinical trial is to investigate whether taking probiotics can improve thinking ability and digestive symptoms in healthy adults, and whether these effects depend on how often someone drinks alcohol. The study will also explore whether probiotics affect mental health, alcohol cravings, and drinking and eating behaviours.
The main questions it aims to answer are:
Read more
- Do probiotics improve everyday thinking, attention, and memory?
- Do probiotics reduce digestion issues or discomfort?
- Does how often someone drinks alcohol affect how much they benefit from probiotics?
- Do probiotics modulate alcohol cravings?
- Do probiotics improve mood, stress, and anxiety levels?
- Do probiotics influence drinking behaviour?
- Do probiotics influence eating behaviour?
Researchers will compare a probiotic supplement to a placebo (a look-alike product with no active ingredients) to see whether probiotics have real effects. Participants will be randomly assigned to one of these groups, and neither the participants nor the researchers will know who is receiving which treatment during the study.
Participants will:
- Take either a probiotic supplement or a placebo every day for 8 weeks
- Complete online questionnaires about their mood, thinking, eating and drinking behaviours, and digestive health at the start and end of the study
- Provide basic lifestyle and demographic information
This study aims to better understand whether probiotics could be a simple and low-cost way to support cognitive function, digestive health, and other wellbeing outcomes in generally healthy adults - and whether these benefits vary depending on how often someone drinks alcohol.
- Conditions
- Healthy Adult
- Being tested
- Probiotic Arm, Placebo Arm
- Keywords
- Gastrointestinal, Cognition, Probiotics, Healthy adults, Alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ArmDietary supplement
The participant will be randomly assigned to receive the probiotic, containing the active ingredient and live bacteria
Placebo ArmDietary supplement
The participant will be randomly assigned to receive the placebo, containing no active ingredient/live bacteria
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Arm |
| Probiotic Group | Active comparator | Not described Receives: Dietary Supplement: Probiotic Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
85 non-clinical participants assessed for Everyday Cognitive Failures by Cognitive Failures Questionnaire 2.0
Everyday cognitive functioning will be assessed using the Cognitive Failures Questionnaire 2.0 (CFQ 2.0), a 15-item self-report questionnaire measuring the frequency of cognitive lapses in daily life (e.g., memory, attention, and action errors). Each item is rated on a 5-point scale. Total scores are calculated by summing all item responses, yielding a score ranging from 0 to 60. Performance will be measured as the total CFQ 2.0 score (range 0-60), with higher scores indicating greater frequency of cognitive failures.
Measured: From enrollment to the end of the treatment at 8 weeks
85 non-clinical participants assessed for Gastrointestinal Symptoms by Gastrointestinal Symptom Rating Scale
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item self-report questionnaire evaluating the severity of common gastrointestinal symptoms. Each item is rated on a 7-point Likert scale, with higher scores indicating more severe symptoms. Total scores are calculated by summing all item responses, yielding a score ranging from 15 to 105. Performance will be measured as the total GSRS score (range 15-105), with higher scores indicating greater gastrointestinal symptom severity. Domain scores may also be calculated by averaging relevant items to assess specific symptom clusters.
Measured: From enrollment to the end of the treatment at 8 weeks
Secondary outcomes (3)
85 non-clinical participants assessed for Drinking Behaviour by Loughborough Alcohol Drinking Questionnaire
Drinking behaviour will be assessed using the Loughborough Alcohol Drinking Questionnaire (LoAD-Q), a 33-item self-report questionnaire measuring three dimensions: emotional drinking, external drinking, and restrained drinking. Each item is rated on a 5-point Likert scale (1 = never to 5 = very often). Subscale scores are calculated by summing item responses within each dimension.
The emotional drinking subscale (13 items) has a score range of 13 to 65, the external drinking subscale (10 items) ranges from 10 to 50, and the restrained drinking subscale (10 items) ranges from 10 to 50. Performance will be measured as subscale total scores, with higher scores indicating greater levels of emotional, external, and restrained drinking behaviour, respectively.
Measured: From enrollment to the end of the treatment at 8 weeks
85 non-clinical participants assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12
Mental health symptoms will be assessed using the Depression Anxiety Stress Scales-12 (DASS-12), a 12-item self-report questionnaire measuring symptoms of depression, anxiety, and stress. Each item is rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 36. Performance will be measured as the total DASS-12 score (range 0-36), with higher scores indicating greater psychological distress.
Measured: From enrollment to the end of the treatment at 8 weeks
85 non-clinical participants assessed for Alcohol Craving by Penn Alcohol Craving Scale
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS), a 5-item self-report questionnaire measuring frequency, intensity, and duration of alcohol cravings over the past week. Each item is rated on a scale from 0 to 6, yielding a total score ranging from 0 to 30. Performance will be measured as the total PACS score (range 0-30), with higher scores indicating greater alcohol craving severity.
Measured: From enrollment to the end of the treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start28 Sep 2025
- Primary completion20 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Cultech Ltd
- Responsible party
- Principal investigator, Kim-Marie Gehrke, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504952
- Sponsor's protocol ID
- 22675
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Alcohol Consumption Moderate the Effects of Probiotic Supplementation on Cognitive and Gastrointestinal Outcomes in a Non-clinical Sample?
- ClinicalTrials.gov ID
- NCT07504952
- Acronym / sponsor ID
- 22675
- Conditions
- Healthy Adult
- Keywords
- Gastrointestinal, Cognition, Probiotics, Healthy adults, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Cultech Ltd
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 1 Apr 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 aim of this clinical trial is to investigate whether taking probiotics can improve thinking ability and digestive symptoms in healthy adults, and whether these effects depend on how often someone drinks alcohol. The study will also explore whether probiotics affect mental health, alcohol cravings, and drinking and eating behaviours.
The main questions it aims to answer are:
- Do probiotics improve everyday thinking, attention, and memory?
- Do probiotics reduce digestion issues or discomfort?
- Does how often someone drinks alcohol affect how much they benefit from probiotics?
- Do probiotics modulate alcohol cravings?
- Do probiotics improve mood, stress, and anxiety levels?
- Do probiotics influence drinking behaviour?
- Do probiotics influence eating behaviour?
Researchers will compare a probiotic supplement to a placebo (a look-alike product with no active ingredients) to see whether probiotics have real effects. Participants will be randomly assigned to one of these groups, and neither the participants nor the researchers will know who is receiving which treatment during the study.
Participants will:
- Take either a probiotic supplement or a placebo every day for 8 weeks
- Complete online questionnaires about their mood, thinking, eating and drinking behaviours, and digestive health at the start and end of the study
- Provide basic lifestyle and demographic information
This study aims to better understand whether probiotics could be a simple and low-cost way to support cognitive function, digestive health, and other wellbeing outcomes in generally healthy adults - and whether these benefits vary depending on how often someone drinks alcohol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo Arm |
| Probiotic Group | Active comparator | Dietary Supplement: Probiotic Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Participants under 18 years of age
- Regular use of probiotics or prebiotics (in supplements or foods) within the past 4 weeks
- Antibiotic use within the past 4 weeks
- Chronic gastrointestinal disorders (e.g. Irritable Bowel Syndrome, Crohn's disease, etc)
- Major psychiatric conditions diagnosed (e.g., bipolar disorder, schizophrenia, etc)
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 |
|---|---|---|
| Probiotic ArmThe participant will be randomly assigned to receive the probiotic, containing the active ingredient and live bacteria | Dietary supplement | Probiotic Group |
| Placebo ArmThe participant will be randomly assigned to receive the placebo, containing no active ingredient/live bacteria | Dietary supplement | Placebo Group |
Primary outcome
85 non-clinical participants assessed for Everyday Cognitive Failures by Cognitive Failures Questionnaire 2.0
Time frame: From enrollment to the end of the treatment at 8 weeks
Everyday cognitive functioning will be assessed using the Cognitive Failures Questionnaire 2.0 (CFQ 2.0), a 15-item self-report questionnaire measuring the frequency of cognitive lapses in daily life (e.g., memory, attention, and action errors). Each item is rated on a 5-point scale. Total scores are calculated by summing all item responses, yielding a score ranging from 0 to 60. Performance will be measured as the total CFQ 2.0 score (range 0-60), with higher scores indicating greater frequency of cognitive failures.
85 non-clinical participants assessed for Gastrointestinal Symptoms by Gastrointestinal Symptom Rating Scale
Time frame: From enrollment to the end of the treatment at 8 weeks
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item self-report questionnaire evaluating the severity of common gastrointestinal symptoms. Each item is rated on a 7-point Likert scale, with higher scores indicating more severe symptoms. Total scores are calculated by summing all item responses, yielding a score ranging from 15 to 105. Performance will be measured as the total GSRS score (range 15-105), with higher scores indicating greater gastrointestinal symptom severity. Domain scores may also be calculated by averaging relevant items to assess specific symptom clusters.
3 secondary outcomes
85 non-clinical participants assessed for Drinking Behaviour by Loughborough Alcohol Drinking Questionnaire
Time frame: From enrollment to the end of the treatment at 8 weeks
85 non-clinical participants assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12
Time frame: From enrollment to the end of the treatment at 8 weeks
85 non-clinical participants assessed for Alcohol Craving by Penn Alcohol Craving Scale
Time frame: From enrollment to the end of the treatment at 8 weeks
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 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arm in people with Healthy Adult, run by Loughborough University 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 0 inclusion and 6 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 10 Sep 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. 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?
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?
85 non-clinical participants assessed for Everyday Cognitive Failures by Cognitive Failures Questionnaire 2.0 (time frame: From enrollment to the end of the treatment at 8 weeks). The study lists 2 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 10 Sep 2026.