Gut feeling: can a friendly bacteria soothe your stomach?
NCT ID NCT07484412
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a probiotic called Bifidobacterium longum BBH016 can improve lower gut symptoms like abdominal pain, diarrhea, and bloating. 88 adults with these symptoms but no constipation will take either the probiotic or a placebo capsule twice daily for 8 weeks. Researchers will track symptom changes, quality of life, and gut bacteria to see if the probiotic helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bifidobacterium longum BBH016 (a probiotic dietary supplement)
- What this could lead to
- If it works, this could point toward a simple, safe probiotic option to help manage common gut symptoms like abdominal pain and diarrhea.
- What could go wrong
- This is a small, early-stage trial with only 88 people. Probiotics often show mixed results, and the effect may be modest or no better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants aged 19 to 80 years. 2. Subjects with lower gastrointestinal (GI) symptoms (diarrhea, loose stools, abdominal bloating, or excessive gas) in whom constipation is not the predominant symptom. 3. Subjects who have undergone colonoscopy within the past 5 years, or who will undergo colonoscopy after enrollment, with confirmation of no organic abnormalities in the colon. Records from another hospital within 5 years may be accepted. If colonoscopy included biopsy or polypectomy, subjects may be eligible if the investigator confirms no clinically significant abnormality. 4. Surgically sterile women or women of childbearing potential with a negative pregnancy test (urine hCG or serum β-hCG). Women of childbearing potential must agree to use appropriate contraception (e.g., oral contraceptives, intrauterine device \[IUD\], double-barrier method, or hormonal implant) throughout the study. 5. Subjects without major neurological or psychiatric disorders that impair decision-making capacity. Those with such conditions may still be eligible if deemed adequately controlled with medication or therapy. 6. Subjects who voluntarily provide written informed consent after receiving adequate explanation of the study. Exclusion Criteria: 1. Subjects with constipation as the predominant lower GI symptom. 2. Pregnant or breastfeeding women. 3. Participation in another clinical trial and receipt of an investigational product within 3 months prior to screening. 4. Any condition judged by the investigator to pose a risk to the subject or interfere with study participation. 5. Severe congestive heart failure or severe angina. 6. Subjects with lactose intolerance or immunosuppression. 7. Use of medications that may affect the study product (e.g., GI medications, probiotics, antibiotics). Probiotics: may participate if discontinued ≥2 weeks before enrollment. Antibiotics or GI medications (potassium-competitive acid blocker, proton pump inhibitor, H2 receptor antagonist, pinaverium, trimebutine, etc.): may participate if discontinued ≥4 weeks before enrollment. If ongoing GI medication use is necessary, dose and regimen must remain unchanged during the study. 8. Uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg at screening), regardless of current therapy. 9. Uncontrolled endocrine or metabolic disease (e.g., diabetes, secondary hyperlipidemia) or hypothyroidism. Patients with hypothyroidism may be included if on stable replacement therapy for ≥4 weeks and TSH is within normal range at screening. 10. Impaired renal function (serum creatinine \>2.0 mg/dL) or nephrotic syndrome at screening. 11. History of malignancy within the past 5 years (except those judged cured). 12. Major psychiatric instability or psychiatric disorders not adequately controlled by therapy. 13. Use of systemic corticosteroids within 1 month prior to screening. 14. History of abdominal surgery other than appendectomy, cholecystectomy, cesarean section, hysterectomy, or hernia repair. Other abdominal surgeries may be allowed if deemed appropriate by the investigator. 15. Any other condition judged by the investigator to make the subject unsuitable for participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seoul National University Bundang Hospital
Seongnam-si, 경기 - Gyeonggi-do, 13629, South Korea
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