A Real-world Study of Gastrointestinal Health and Mental Wellness in U.S. Adults Following 12 Weeks of Probiotic Supplementation.

NCT07849036 | Not Yet Recruiting

• 1 other identifier: HHB-GI-26-03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults Reporting Recurrent Gastrointestinal Symptoms

Keywords

Probiotics; Gastrointestinal health; Wellbeing; Gut-brain axis

Outcome Measures

Primary Outcomes (1)

• Mean change in PROMIS Belly Pain 5a T-score

  Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

  From baseline to end of week 12

Secondary Outcomes (11)

• Mean change in PROMIS Diarrhea 6a T-score

  From baseline to end of week 12

• Mean change in PROMIS Constipation 9a T-score

  From baseline to end of week 12

• Mean change in PROMIS Gas and Bloating 13a (v1.1) T-score

  From baseline to end of week 12

• Mean change in PROMIS Emotional Distress - Anxiety 6a T-score

  From baseline to end of week 12

• Mean change in PROMIS Fatigue 6a T-score

  From baseline to end of week 12

Other Outcomes (6)

• Mean changes during probiotic wash-out in PROMIS T-scores (all GI and psychosocial domains respectively)

  From end of week 12 to end of week 16

• Mean changes during probiotic wash-out in Visual Analogue Mood Scale (VAMS) score

  From end of week 12 to end of week 16

• Mean changes during probiotic wash-out in self-reported dietary behaviours

  From end of week 12 to end of week 16

Study Arms (1)

Probiotic

EXPERIMENTAL

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Probiotic

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novonesis: lead

Study Sites (1)

Comet Clinical

Cardiff, United Kingdom

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Katy Sorensen, MSc

  Novonesis

  STUDY DIRECTOR

• Eamonn MM Quigley, MD

  Underwood Center for Digestive Health, Houston Methodist Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Contract Research Organisation: Comet Clinical

CONTACT

+1 888 493 8023; studyGBR@cometclinical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-group, open-label study in which healthy adults living in the U.S.A will consume a daily dietary supplement (2 capsules per day containing Bifidobacterium longum (35624™) and Bifidobacterium longum (1714™) once daily for 12 weeks). Participants will be followed remotely during the 12 week supplementation period and a subsequent 4-week wash-out period, using electronic participant-reported outcomes, salivary cortisol samples and safety monitoring. There is no randomisation, blinding or control group.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)