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Clinical Trials in the UK / NCT07849036
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A Real-world Study of Gastrointestinal Health and Mental Wellness in U.S. Adults Following 12 Weeks of Probiotic Supplementation.

NCT07849036 · tracked via the Priya Life Science UK tracker
Sponsor
Novonesis
Phase
Not applicable
Started
2027-01
Last updated
2026-09-30

Condition(s) studied

Healthy Adults Reporting Recurrent Gastrointestinal Symptoms

Investigational drug(s) / intervention(s)

Probiotic

Probiotic: Two capsules to be self-administered orally once daily, each containing 5 x 10\^9 colony-forming units (CFU) of Bifidobacterium longum (1714™) and Bifidobacterium longum (35624™) combined, equating to a total daily probiotic dose of 1 x 10\^10 CFU, for 12 weeks.

Study summary

This real-world study conducted in the U.S.A aims to understand how gastrointestinal (GI) symptoms and wellbeing, including mood, sleep, and eating behaviours, change over time in 300 adults who choose to take a probiotic dietary supplement (often called "good bacteria", like the kind found in yogurt). This study looks at how a probiotic supplement may affect digestive symptoms and wellbeing.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Females or males at least 18 years of age at the planned start date. * Reporting mild-to-moderate GI symptoms at screening, defined as recurrent abdominal pain or discomfort at least 3 days per month on average in the last 3 months, associated with bowel movement (either improvement or exacerbation), and a change in the form and/or frequency of bowel movements, with initial onset of symptoms at least 6 months ago. An adaptive design will allow recruitment of participants with initial onset of at least 3 months ago, in case of recruitment delays. * Owner of a personal smartphone which: (i) only they have access to, and (ii) has Apple AppStore or Android store access to the free-to-use Trialflare app. * Willing to: * Consume the dietary supplement daily for the duration of the study * Collect salivary samples according to instructions at baseline and week 4 * Complete other study assessments digitally Exclusion Criteria: Individuals meeting any of the following criteria will be excluded: * Pregnant, breastfeeding, or planning pregnancy during the study period * Known allergy or intolerance to any component of the study product * Presence of a significant medical, gastrointestinal, neurological, or psychiatric condition which, in the opinion of the Principal Investigator (PI), may pose a safety risk to the participant or interfere with interpretation of the study results. Conditions considered during eligibility assessment include, but are not limited to: * Coeliac disease * Inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis * Gastrointestinal cancer * Previous removal of part of the bowel (bowel resection), or presence of a colostomy or ileostomy * Other significant gastrointestinal conditions * Significant neurological or neurodegenerative conditions (for example Parkinson's disease, motor neurone disease or Alzheimer's disease) * Major psychiatric illness requiring hospital admission within the past 12 months, or currently unstable psychiatric treatment Final eligibility determination will remain at the discretion of the Principal Investigator, taking into consideration the participant's current health status, treatment history, and suitability for participation. * Current or recent (within the last 1 month) use of: * Antibiotics * Other probiotic products * Supplements intended to affect GI health, mood, sleep, stress, or anxiety * Current use of a GLP-1 receptor agonist medication where the participant has not been receiving a stable dose for at least 8 weeks prior to enrolment, or where a dose change is anticipated during the study period. * Participation in another clinical or nutritional study that could interfere with this study, any other condition or circumstance which, in the opinion of the PI, may make the participant unsuitable for the study, including concerns regarding compliance with study procedures or reliability of data submission.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Comet Clinical Cardiff United Kingdom

More Novonesis trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07849036 on ClinicalTrials.gov ↗ ← All trials in the UK