Active — Not RecruitingNot Applicable

Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms

South Korea88 participantsStarted 2025-08-01

Plain-language summary

Functional lower gastrointestinal (GI) symptoms such as abdominal pain, diarrhea, loose stools, and bloating are common in adults without identifiable organic disease and are associated with impaired quality of life and increased healthcare utilization. Growing evidence suggests that alterations in the gut microbiota may contribute to the development of these symptoms, supporting the potential role of probiotics as a therapeutic strategy. Bifidobacterium longum BBH016 is a probiotic strain isolated from a healthy donor and classified as Generally Recognized as Safe (GRAS). Preclinical studies have suggested that BBH016 may alleviate abdominal symptoms, reduce intestinal inflammation, and improve gut microbial balance. This investigator-initiated, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of BBH016 capsules in adults with functional lower GI symptoms excluding constipation-predominant presentations. The study will be conducted at Seoul National University Bundang Hospital. A total of 88 participants aged 19-80 years will be randomized in a 1:1 ratio to receive either BBH016 capsules or placebo for 8 weeks (two capsules twice daily). Participants will be assessed at baseline, 4 weeks, and 8 weeks. The primary endpoint is overall improvement in GI symptoms at week 8 compared with baseline between treatment groups. Secondary endpoints include changes in individual symptom scores, IBS Symptom Severity Score (IBS-SSS), IBS Quality of Life (IBS-QoL), stool frequency and form assessed by the Bristol Stool Form Scale, and psychological well-being measured using the Hospital Anxiety and Depression Scale (HADS). Stool samples will also be collected to evaluate changes in the gut microbiome and their association with clinical outcomes.

Who can participate

Age range

19 Years – 80 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participants aged 19 to 80 years.
. Subjects with lower gastrointestinal (GI) symptoms (diarrhea, loose stools, abdominal bloating, or excessive gas) in whom constipation is not the predominant symptom.
. 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.
. Surgically sterile women or women of childbearing potential with a negative pregnancy test (urine hCG or serum β-hCG).
. Subjects without major neurological or psychiatric disorders that impair decision-making capacity.
. Subjects who voluntarily provide written informed consent after receiving adequate explanation of the study.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

General symptom scale assessment

Timeframe: 8weeks post treatment initiation

Trial details

NCT IDNCT07484412

SponsorSeoul National University Bundang Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-24

View on ClinicalTrials.gov More Lower Abdominal Pain trials