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

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

Detailed Description
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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

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

Conditions
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Combizym, Bifidobacteri, Colon Polyps

Intervention / Treatment
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* Drug: Combizym
* Drug: Bifidobacteri
* Drug: Combizym + Bifidobacteri


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combizym-treated group<br>The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly. | Drug: Combizym<br>* Combizym( 1 tablet, po, tid)<br>* Other names: (provided by Nordmark Arzneimittel GmbH & Co. KG);|
| Active Comparator: Bifidobacteri-treated group<br>The patients who received polypectomy of colon polyps take Bifidobacteri regularly | Drug: Bifidobacteri<br>* Bifidobacteri (2 tablet, po, tid)<br>* Other names: (produced by Shanghai XinYi Company);|
| Active Comparator: Combizym + Bifidobacteri-treated group<br>The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly | Drug: Combizym + Bifidobacteri<br>* Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)<br>* Other names: (produced by Shanghai XinYi Company);|
| No Intervention: control<br>The patients who received polypectomy of colon polyps take no drugs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |