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Clinical effect of Saccharomyces Boulardii Sachets combined with mesalazine in the treatment of ulcerative colitis

Clinical effect of Saccharomyces Boulardii Sachets combined with mesalazine in the treatment of ulcerative colitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118353
Enrollment
Unknown
Registered
2026-02-04
Start date
2026-02-12
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Ulcerative Colitis

Interventions

Observation Group:Mesalazine enteric-coated tablets, oral: 1.0 g per dose, three times daily
Boulardii Sachets, oral: 0.5 g per dose, twice daily.
Control Group:Mesalazine enteric-coated tablets, oral: 1.0 g per dose, three times daily
Boulardii Sachets placebo, oral: 0.5 g per dose, twice daily.

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for ulcerative colitis outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi’an)" [18]; 2.Aged 18–80 years, with no restriction on sex; 3. No severe cardiovascular, hepatic, renal, or endocrine system diseases; 4. Voluntarily signs an informed consent form to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who have used other probiotic medications within the past 7 days; 2.Patients currently taking antifungal medications; 3. Patients with central venous catheters; 4. Pregnant or lactating women; 5.Patients allergic to the medications used in this study; 6. Patients currently enrolled in other clinical studies; 7.Any other conditions deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy rate;

Secondary

MeasureTime frame
Mayo Clinical Score;C-reactive protein;Erythrocyte Sedimentation Rate;Calprotectin;Gut microbiota;Metabolomics Analysis;Mesalazine Blood Concentration;Disease-Related Computational Index;Time of disappearance of clinical symptoms;

Countries

China

Contacts

Public ContactZhong Xiaolin

The Affiliated Hospital of Southwest Medical University

Laurie68@163.com+86 189 8913 7959

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026