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Effect of Bifidobacterium Tetragenous Viable Bacteria Tablets (Si Lian kang) on intestinal microbiota and clinical symptoms after colonoscopy

Effect of Bifidobacterium Tetragenous Viable Bacteria Tablets (Si Lian kang) on intestinal microbiota and clinical symptoms after colonoscopy: A randomized, double-blind, placebo-controlled, multi-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021736
Enrollment
Unknown
Registered
2019-03-07
Start date
2019-03-25
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

intestinal microbiota imbalance after colonoscopy

Interventions

experimental group:Bifidobacterium Tetragenous Viable Bacteria Tablets
control group:pIacebo

Sponsors

The First Medical Center of The PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sign informed consent voluntarily; 2. Aged 18 to 75 years, male or female; 3. Outpatients with indications for colonoscopy.

Exclusion criteria

Exclusion criteria: 1. Patient with systemic or local malignancy, or patient who cannot discontinue immunosuppressive agents; 2. Patient with digestive diseases that have a great impact on the study: including inflammatory bowel disease, infectious gastro-intestinal disease, colorectal polyps (size=2cm or quantity>3 or requiring EMR); 3. Fecal occult blood (+) or white blood cells (+); when the fecal occult blood (+), but the colonoscopy results are normal, the patient can be included in the study; 4. Patient with severe psychiatric or psychological disease; 5. Patient with a history of drug abuse or alcohol abuse, or those who drink a lot or take antibiotics in the past month; 6. Patient who is allergic to the study drug; 7. Patient who cannot discontinue the drugs or health products or foods during the trial which can cause diarrhea or affect intestinal microbiota, including cathartics, antibiotics, probiotic-containing drugs/health products/foods/ yogurt, etc. 8. Patient who underwent colonoscopy (or bowel preparation) in the past month; 9.Women who are pregnant or breastfeeding; 10. Patients who are participating or have completed other clinical trials less than 3 months ago; 11. The patient was considered unsuitable for inclusion by other investigators.

Design outcomes

Primary

MeasureTime frame
The incidence of diarrhea within 14 days;

Secondary

MeasureTime frame
Evaluation of symptoms;Changes in intestinal microbiota;

Countries

China

Contacts

Public ContactYunsheng Yang

The General Hospital of People's Liberation Army

sunny301ddc@126.com+86 010 55499005

Outcome results

None listed

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