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OpenTrials
Completed

NCT Number: NCT07504952

Investigating the Impact of Probiotics on Wellbeing in a Community

The goal of this clinical trial is to find out whether taking probiotics can improve thinking ability and gut (digestive) symptoms in healthy adults. 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? * 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

  • Participants under 18 years of age
  • Current 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

Treatment and study plan

Probiotic Arm

Dietary Supplement

The participant will be randomly assigned to receive the probiotic, containing the active ingredient and live bacteria

Placebo Arm

Dietary Supplement

The participant will be randomly assigned to receive the placebo, containing no active ingredient/live bacteria

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

Other outcomes

  1. 85 non-clinical participants assessed for Disordered Eating by Eating Disorder Examination Questionnaire Short Form

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Disordered eating behaviours will be assessed using the Eating Disorder Examination Questionnaire Short Form (EDE-QS), a 12-item self-report questionnaire measuring eating disorder psychopathology over the past 7 days. Each item is rated on a 4-point scale (0-3), yielding a total score ranging from 0 to 36. Performance will be measured as the total EDE-QS score (range 0-36), with higher scores indicating greater severity of disordered eating behaviours.

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • Innovate UK

Registry information

Official study title

Effects of Probiotic Supplementation on Cognitive Lapses and Gastrointestinal Symptoms in a Non-Clinical Population: A Randomised, Placebo-Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.