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

Phase 4UnknownNCT02097394

RenJi Hospital200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Combizym Bifidobacteri Colon Polyps

Interventions

CombizymDRUG

Combizym( 1 tablet, po, tid)

BifidobacteriDRUG

Bifidobacteri (2 tablet, po, tid)

Combizym + BifidobacteriDRUG

Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

Time frame: one year

Data from ClinicalTrials.gov

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