Investigating the Impact of Probiotics on Wellbeing in a Community

NCT07504952 | Completed

• 1 other identifier: 22675
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

This Study Focus Focuses on a Non-clinical Sample of Generally Healthy Adults, and Whether Probiotics Offer Any Holistic Health Benefits

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  From enrollment to the end of the treatment at 8 weeks

• 85 non-clinical participants assessed for Alcohol Craving by Penn Alcohol Craving Scale

  From enrollment to the end of the treatment at 8 weeks

Other Outcomes (1)

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

  From enrollment to the end of the treatment at 8 weeks

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Dietary Supplement: Placebo Arm

Probiotic Group

ACTIVE COMPARATOR

Dietary Supplement: Probiotic Arm

Interventions

Probiotic Arm DIETARY_SUPPLEMENT

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

Probiotic Group

Placebo Arm DIETARY_SUPPLEMENT

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

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead
• Innovate UK: collaborator

Study Sites (1)

Loughborough University

Loughborough, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Research Student

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 1, 2026
• Study Start: September 28, 2025
• Primary Completion: February 20, 2026
• Study Completion: March 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

GB (1)