Overview

This trial is active, not recruiting.

Conditions combizym, bifidobacteri, colon polyps
Treatments combizym, bifidobacteri, combizym + bifidobacteri, control
Phase phase 4
Sponsor RenJi Hospital
Start date June 2013
End date June 2016
Trial size 200 participants
Trial identifier NCT02097394, RJYYXHNK-002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
These patients who have cutted colon polyps will eat the digestion enzyme(Combizym) regularly.
combizym Oryz-Aspergillus Enzyme And Pancreatin Tablet
Combizym( 1 tablet, po, tid)
(Active Comparator)
These patients who have cutted colon polyps will eat Bifidobacteri regularly
bifidobacteri Live Combined Bifidobacterium,Lactobac and Enterococcus Capsules
Bifidobacteri (2 tablet, po, tid)
(Active Comparator)
These patients who have cutted colon polyps will eat drugs (Combizym + Bifidobacteri) regularly
combizym + bifidobacteri Combizym(Oryz-Aspergillus Enzyme And Pancreatin Tablet)
Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)
(Active Comparator)
these patients who have cutted colon polyps will not eat any drugs
control
have no any drug

Primary Outcomes

Measure
recurrence of colon polyps
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Randomized Controlled Study on Combizym and Bifidobacteria to Prevent the Recurrence 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by RenJi Hospital.