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

Phase 4

• Conditions: Combizym; Colon Polyps; Bifidobacteri
• Interventions: Drug: Bifidobacteri; Drug: Combizym + Bifidobacteri; Drug: Combizym

• Registration Number: NCT02097394
• Lead Sponsor: RenJi Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bifidobacteri-treated group	Bifidobacteri	The patients who received polypectomy of colon polyps take Bifidobacteri regularly
Combizym + Bifidobacteri-treated group	Combizym + Bifidobacteri	The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly
Combizym-treated group	Combizym	The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly.

Primary Outcome Measures

Name	Time	Method
recurrence of colon polyps	one year	The whole patients need be examined by colonoscopy one year later. The recurrence rate of colon polyps will be acquired in different arms

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China