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Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis: a randomized double-blind controlled trial

Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032498
Enrollment
Unknown
Registered
2020-04-30
Start date
2020-09-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Ulcerative colitis

Interventions

Experimental group:Probiotics and prebiotics

Sponsors

Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with unlimited gender, aged >= 18 years, willing to sign informed consent; 2. Patients who meet the diagnostic criteria in the consensus opinion on the diagnosis and treatment of inflammatory bowel disease (2018 Edition); 3. Patients with mild or moderate disease course > 3 months; 4. Patients who have not received antibiotic treatment or taken commercial probiotic preparations in the past three months; 5. HIV negative, HTLV I / II negative, fecal culture negative, C diff toxin negative, CMV negative.

Exclusion criteria

Exclusion criteria: 1. Patients with complications of UC. 2. Patients with a previous history of gastrointestinal surgery or original organic gastrointestinal disease. 3. Long term use of mesalazine preparations, hormones and immunosuppressants, antibiotics or laxatives. 4. Patients with a history of diabetes, stroke, heart disease, or mental illness. 5. Patients who participate in other clinical trials or researchers think that they should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
clinical activity index;

Secondary

MeasureTime frame
Sigmoidoscopy score;bowl habit index;Inflammation status score of colorectal biopsy tissue samples;Immunohistochemical analysis of inflammatory markers in biopsies;The index of the barrier function of blood midgut mucosa;Fecal inflammation index;Microgenomics of intestinal mucosa;

Countries

China

Contacts

Public ContactPenggao Li

Capital Medical University

penggao@ccmu.edu.cn+86 13641331852

Outcome results

None listed

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