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Investigating the Impact of Probiotics on Wellbeing in a Community

L

Loughborough University

Status

Completed

Conditions

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

Treatments

Dietary Supplement: Probiotic Arm
Dietary Supplement: Placebo Arm

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

85 participants in 2 patient groups, including a placebo group

Placebo Group
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo Arm
Probiotic Group
Active Comparator group
Treatment:
Dietary Supplement: Probiotic Arm

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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