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A Randomized, Double-Blind, Placebo-Controlled Study on Bifidobacterium-Lactobacillus Triple Live Bacteria in Regulating Small Intestinal Bacterial Overgrowth and Intestinal Mucosal Barrier in Patients with Inflammatory Bowel Disease

A Randomized, Double-Blind, Placebo-Controlled Study on Bifidobacterium-Lactobacillus Triple Live Bacteria in Regulating Small Intestinal Bacterial Overgrowth and Intestinal Mucosal Barrier in Patients with Inflammatory Bowel Disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112578
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-11-30
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Interventions

control group:placebo
experimental group:Bifidobacterium-Lactobacillus Triple Live Bacteria

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Definitive diagnosis of inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), based on comprehensive analysis. (2) Aged 15 to 80 years, regardless of gender. (3) Voluntary participation in the study and signing of a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with Crohn's disease (CD) having a Best CDAI score > 450, or patients with ulcerative colitis (UC) having a modified Mayo score > 10. (2) Those who refuse to sign the informed consent form. (3) Those who have used antibiotics, probiotics, prebiotics, or other drugs that may affect intestinal microecology within the past 2 weeks. (4) Those with severe diseases such as diabetes mellitus, thyroid dysfunction, severe hepatic or renal insufficiency, cardio-cerebrovascular diseases, or malignant tumors, which may interfere with the assessment of study results. (5) Those with gastric cancer, peptic ulcer, intestinal cancer, dysplasia, or other organic gastrointestinal diseases detected by gastroenteroscopy within the past year. (6) A history of abdominal surgery (excluding appendectomy and cesarean section). (7) A known history of allergy to fluorescein or severe allergic reactions (e.g., laryngeal edema, anaphylactic shock) following previous injections. (8) A history of asthma, or allergies to cephalosporins or penicillins. (9) Patients receiving concurrent ß-blocker therapy (intravenous fluorescein administration is relatively contraindicated in patients on ß-blockers according to the statement of the German Federal Institute for Drugs and Medical Devices). (10) Patients taking antihypertensive drugs, or those with hypotension or bradycardia. (11) Those who have recently taken nephrotoxic drugs (e.g., aminoglycoside antibiotics). (12) Pregnant or lactating women, or those planning to become pregnant within the next 3 months. (13) Patients with mental illness or cognitive impairment who are unable to cooperate with the study procedures. (14) Patients deemed unsuitable for participation in this clinical trial by the investigators.

Design outcomes

Primary

MeasureTime frame
The cure rate of SIBO/IMO in IBD patients;

Secondary

MeasureTime frame
Intestinal mucosal barrier indicators;Intestinal microbiota;Oral microbiota;

Countries

China

Contacts

Public ContactLing Liu

West China Hospital, Sichuan University

lingzipurple@163.com+86 189 8060 6772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026