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Effect and mechanism of probiotics on ulcerative colitis

A randomized, blinded clinical trial of probiotic Bifidobacterium breve CGMCC No.11828 and Bifidobacterium longum GDMCC No.60310 in relieving ulcerative colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065108
Enrollment
Unknown
Registered
2022-10-28
Start date
2022-10-31
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

ulcerative colitis

Interventions

Placebo group:Placebo+Mesalazine
Bifidobacterium breve CGMCC No.11828:Bifidobacterium breve CGMCC No.11828+Mesalazine
Bifidobacterium longum GDMCC No.60310:Bifidobacterium longum GDMCC No.60310+Mesalazine

Sponsors

The Peoples' Hospital of Tinghu District of Yancheng City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets UC diagnosis; 2. The condition is mild to moderate and in an active period; 3.18 years old<=age<=65 years, regardless of gender; 4. Have not taken yogurt, beverages, and other foods containing probiotics (such as lactic acid bacteria, bifidobacteria, etc.) within the past 2 months, and have been able to consistently take probiotic products according to requirements for 2 months, cooperating with investigations and collecting biological samples such as blood and feces; 5. Those who voluntarily participate and sign an informed consent form shall be the research subjects.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Recent or long-term use of antibiotics, etc; 3. Intestinal diseases accompanied by diabetes, cardiovascular and cerebrovascular diseases, or complications with a history of malignant diseases, and any intestinal diseases that interfere with the evaluation of test results; 4. Those with severe complications of the digestive tract, such as intestinal perforation, local stenosis, intestinal obstruction, toxic megacolon, and gastrointestinal bleeding; 5. Unable to tolerate colonoscopy examination; 6. Merge other types of immune system diseases; 7. Individuals with mental illness who cannot cooperate.

Design outcomes

Primary

MeasureTime frame
Electronic colonoscope;Colon pathology;Fecal gut microbiota;Fecal metabolites;Metabolites in serum;Serum inflammatory index;IBDQ scale;Ulcerative Colitis Endoscopic Index of Severity;Mayo Clinic Score;

Secondary

MeasureTime frame
Height;Weight;

Countries

China

Contacts

Public ContactJianxin Zhao

The Peoples' Hospital of Tinghu District of Yancheng City ; Jiangnan University

zhaojianxin@jiangnan.edu.cn+86 13606189172

Outcome results

None listed

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