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

NCT07484412 | Active Not Recruiting

• 2 other identifiers: B-2505-971-00420018499
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Abdominal Pain; Diarrhea; Irritable Bowel Syndrome

Keywords

Bifidobacterium longum BBH016; probiotics

Outcome Measures

Primary Outcomes (1)

• General symptom scale assessment

  Participants will rate overall improvement in gastrointestinal symptoms using a patient-reported numeric scale ranging from 0 to 10 (0 = no improvement; 10 = complete symptom improvement). Higher scores indicate greater symptom improvement.

  8weeks post treatment initiation

Secondary Outcomes (9)

• IBS Symptom Severity Score (IBS-SSS)

  8weeks post treatment initiation

• IBS Quality of Life (IBS-QoL)

  8weeks post treatment initiation

• Bristol stool form scale

  8weeks post treatment initiation

• Abdominal Pain Severity Score (5-point Likert scale)

  8 weeks post treatment initiation

• Abdominal Discomfort Severity Score (5-point Likert scale)

  8 weeks post treatment initiation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching placebo capsule (2 caps BID for 8 weeks)

Dietary Supplement: Placebo Capsule(s)

Experimental_BBH016 capsule

EXPERIMENTAL

Bifidobacterium longum BBH016 capsule (2 caps BID for 8 weeks)

Dietary Supplement: Bifidobacterium longum BBH016

Interventions

Bifidobacterium longum BBH016 DIETARY_SUPPLEMENT

BBH016 capsule (2 caps BID for 8 weeks)

Experimental_BBH016 capsule

Placebo Capsule(s) DIETARY_SUPPLEMENT

placebo capsule (2 caps BID for 8 weeks)

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• 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.
• Subjects who voluntarily provide written informed consent after receiving adequate explanation of the study.

You may not qualify if:

• Subjects with constipation as the predominant lower GI symptom.
• Pregnant or breastfeeding women.
• Participation in another clinical trial and receipt of an investigational product within 3 months prior to screening.
• Any condition judged by the investigator to pose a risk to the subject or interfere with study participation.
• Severe congestive heart failure or severe angina.
• Subjects with lactose intolerance or immunosuppression.
• 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.
• Uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg at screening), regardless of current therapy.
• 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.
• Impaired renal function (serum creatinine \>2.0 mg/dL) or nephrotic syndrome at screening.
• History of malignancy within the past 5 years (except those judged cured).
• Major psychiatric instability or psychiatric disorders not adequately controlled by therapy.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 경기 - Gyeonggi-do, 13629, South Korea

Location

MeSH Terms

Conditions

Diarrhea; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, randomized, double-blind, placebo-controlled, single-center trial at SNUBH. Adults 19-80 with lower GI symptoms (abdominal pain, diarrhea/loose stools, bloating) without organic disease; constipation-predominant presentations excluded. After screening (eligibility, labs, colonoscopy confirmation per protocol), participants are randomized 1:1 to BBH016 (two capsules twice daily) or identical placebo for 8 weeks. Visits at baseline (V1), week 4 (V2; in-person or phone), and week 8 (V3); stool collected at V1 and V3; safety labs at V0/V1/V3. Primary endpoint: overall improvement in GI symptoms at week 8 vs baseline between groups. Secondary endpoints: symptom subscores, IBS-SSS, IBS-QoL, BSFS, HADS, and gut microbiome changes. Safety monitoring includes AEs, vitals, and laboratory parameters; trial insurance in place; blinding maintained for participants, investigators, and staff.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 20, 2026
• Study Start: August 1, 2025
• Primary Completion: February 24, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

KR (1)