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ACTIVE NOT RECRUITING
NCT07840066
NA

Probiotics in Wellbeing

Sponsor: University of Reading

View on ClinicalTrials.gov

Summary

This study will investigate whether taking a probiotic supplement every day for 12 weeks can reduce low-level inflammation and improve wellbeing in generally healthy adults. Forty adults will be randomly assigned to receive either a probiotic capsule or a placebo capsule that looks the same but does not contain probiotic bacteria. Neither the participants nor the researchers involved in the study will know which treatment each participant receives until the study is completed. Participants will attend a study visit before starting the supplement and another visit after 12 weeks, with a remote check midway through the study. Blood samples will be collected to measure markers of inflammation and stress. Stool samples will be collected to assess the gut microbiota and substances produced by gut bacteria. Urine samples will also be collected to measure metabolites, which are small molecules produced by normal processes in the body and by interactions between the body, diet and gut microbiota. Participants will also complete questionnaires about wellbeing, mood, anxiety, quality of life and memory. The main aim of the study is to determine whether the probiotic reduces a combined measure of several markers of inflammation compared with placebo. The study will also explore whether changes in inflammation are associated with changes in wellbeing and memory, and whether these effects are accompanied by changes in the gut microbiota or in metabolic profiles measured in stool and urine. The results will help researchers understand how probiotics may influence communication between the gut, immune system and brain, and will provide information to help design a larger clinical trial.

Official title: A Randomised Controlled Trial Investigating the Probiotic-mediated Suppression of Inflammatory Cytokines as a Mechanism for Improving Wellbeing

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09-01

Completion Date

2027-09

Last Updated

2026-09-24

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Probiotic Supplementation (Lactobacillus plantarum)

Daily oral administration of one capsule of a multi-strain probiotic supplement (Optibac "Every Day") for 12 weeks. Each daily dose provides 5 × 10⁹ CFU and contains Lactobacillus rhamnosus Rosell-11 (R0011), Lactobacillus acidophilus/helveticus Rosell-52 (R0052), Bifidobacterium longum Rosell-175 (R0175), Bifidobacterium breve Rosell-70 (R0070), Bifidobacterium bifidum Rosell-71 (R0071), and Lactococcus lactis Rosell-1058 (R1058), together with fructooligosaccharides (FOS). Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling.

DIETARY_SUPPLEMENT

Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention.

Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention in capsule shell, appearance and fill weight. Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling.

Locations (1)

The University of Reading

Reading, Berkshire, United Kingdom