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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07849036
- Acronym / sponsor ID
- HHB-GI-26-03
- Keywords
- Probiotics, Gastrointestinal health, Wellbeing, Gut-brain axis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- NovonesisIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (17 listed)
- 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:
- Current or recent (within the last 1 month) use of:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticTwo 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. | Dietary supplement | Probiotic |
Primary outcome
Mean change in PROMIS Belly Pain 5a T-score
Time frame: From baseline to end of week 12
Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16
11 secondary outcomes
Mean change in PROMIS Diarrhea 6a T-score
Time frame: From baseline to end of week 12
Mean change in PROMIS Constipation 9a T-score
Time frame: From baseline to end of week 12
Mean change in PROMIS Gas and Bloating 13a (v1.1) T-score
Time frame: From baseline to end of week 12
Mean change in PROMIS Emotional Distress - Anxiety 6a T-score
Time frame: From baseline to end of week 12
Mean change in PROMIS Fatigue 6a T-score
Time frame: From baseline to end of week 12
Mean change in PROMIS Sleep Disturbance 6a T-score
Time frame: From baseline to end of week 12
Mean change in PROMIS Cognitive Function 8a (v2.0) T-score
Time frame: From baseline to end of week 12
Mean change in Visual Analogue Mood Scale (VAMS) score
Time frame: From baseline to end of week 12
Mean change in self-reported dietary behaviours
Time frame: 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
Time frame: At end of week 12
Mood responder rate, defined as a participant achieving a ≥20% improvement in VAMS score from baseline to week 12
Time frame: At the end of week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katy Sorensen, MSc study director
Novonesis
Eamonn MM Quigley, MD principal investigator
Underwood Center for Digestive Health, Houston Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy Adults Reporting Recurrent Gastrointestinal Symptoms, run by Novonesis at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Contract Research Organisation: Comet Clinical (+1 888 493 8023, studyGBR@cometclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in PROMIS Belly Pain 5a T-score (time frame: From baseline to end of week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.