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A prospective, multicenter, randomized controlled clinical study on the effect of compound preparation Biolosion in adjuvant treatment of ulcerative colitis

A prospective, multicenter, randomized controlled clinical study on the effect of compound preparation Biolosion in adjuvant treatment of ulcerative colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072352
Enrollment
Unknown
Registered
2023-06-12
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

ulcerative colitis

Interventions

Combination group:Biolosion plus mesalazine

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients with mild to moderate UC(Mayo Clinic score 3-10) 2) Patients were diagnosed by clinical manifestations, laboratory examinations, imaging, endoscopy, and histopathology; 3) No gender limitation, and the range of age between 18-70; 4) UC confirmed by colonoscopy and histology was active for more than 1 week; 5) The length of the lesion was =15cm under colonoscopy.

Exclusion criteria

Exclusion criteria: 1) More than moderate disease activity; 2) Hemoglobin < 80g/L; 3) Active intestinal infection; 4) Antibiotic use within the past 2 weeks or a change in an oral dose of 5-aminosalicylic acid (5-ASA) within the past 4 weeks, rectal use of 5-ASA within 7 days prior to study entry or Steroids; 5) lactating women and pregnant women; 6) Patients receiving any investigational drug or taking commercially available probiotic preparations within 3 months; 7) Patients with obvious liver, kidney, endocrine, respiratory, neurological, or cardiovascular diseases; 8) A history of atypical hyperplasia of the colon or any cancer within 5 years.

Design outcomes

Primary

MeasureTime frame
Mayo Clinic score;

Secondary

MeasureTime frame
Inflammatory factor;Laboratory examination index;imageological examination;Intestinal flora;

Countries

China

Contacts

Public ContactXiang Gao

The Sixth Affiliated Hospital, Sun Yat-sen University

gxiang@mail.sysu.edu.cn+86 135 0240 5878

Outcome results

None listed

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