Healthy Adults Reporting Recurrent Gastrointestinal SymptomsNCT07849036
A Real-world Study of Gastrointestinal Health and Mental Wellness in U.S. Adults Following 12 Weeks of Probiotic Supplementation.
A study testing Probiotic in people with Healthy Adults Reporting Recurrent Gastrointestinal Symptoms, run by Novonesis at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults Reporting Recurrent Gastrointestinal Symptoms
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2027to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Real-World Study Assessing Changes in Gastrointestinal Health and Mental Wellness in U.S. Adults Following 12 Weeks of Probiotic Supplementation.
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.
- Being tested
- Probiotic
- Keywords
- Probiotics, Gastrointestinal health, Wellbeing, Gut-brain axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in PROMIS Belly Pain 5a T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Secondary outcomes (11)
Mean change in PROMIS Diarrhea 6a T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in PROMIS Constipation 9a T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in PROMIS Gas and Bloating 13a (v1.1) T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in PROMIS Emotional Distress - Anxiety 6a T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in PROMIS Fatigue 6a T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in PROMIS Sleep Disturbance 6a T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in PROMIS Cognitive Function 8a (v2.0) T-score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in Visual Analogue Mood Scale (VAMS) score
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
Mean change in self-reported dietary behaviours
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
Measured: From baseline to end of week 12
GI symptom responder rate, defined as a participant achieving a ≥5-point reduction in T-score from baseline to week 12 in PROMIS T-scores for Belly Pain 5a
Measured: At end of week 12
Mood responder rate, defined as a participant achieving a ≥20% improvement in VAMS score from baseline to week 12
Measured: At the end of week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adults Reporting Recurrent Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novonesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katy Sorensen, MSc, Study director, NovonesisEamonn MM Quigley, MD, Principal investigator, Underwood Center for Digestive Health, Houston Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849036
- Sponsor's protocol ID
- HHB-GI-26-03
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No