The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps

Colon Polyps Clinical Trial

Official title:

A Randomized Controlled Study on Combizym and Bifidobacteria to Prevent the Recurrence of Colon Polyps

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02097394
• Other study ID #: RJYYXHNK-002
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: June 2020

Study information

• Verified date: March 2020
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps

Description:

Colon polyps has high recurrence rate in the digestion diseases. However, the reasons are not clear. The possible reasons for the recurrence of colon polyps include intestinal inflammation (e.g., Ulcerative colitis), intestinal flora imbalance (the benefit intestinal bacteria reduced, which lead to diarrhea or constipation), long-term indigestion. The investigators propose to examine whether digestion enzyme (Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

-Patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis

Exclusion Criteria:

• have organic or other functional disease

• pregnant or breast-feeding

Related Conditions & MeSH terms

• Bifidobacteri
• Colon Polyps
• Colonic Polyps
• Combizym
• Polyps
• Recurrence

Intervention

Drug:
• Combizym
Combizym( 1 tablet, po, tid)
• Bifidobacteri
Bifidobacteri (2 tablet, po, tid)
• Combizym + Bifidobacteri
Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of colon polyps	The whole patients need be examined by colonoscopy one year later. The recurrence rate of colon polyps will be acquired in different arms	one year