Back to resultsThe Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps
Primary Purpose
Combizym, Bifidobacteri, Colon Polyps
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Combizym
Bifidobacteri
Combizym + Bifidobacteri
Sponsored by
About this trial
This is an interventional prevention trial for Combizym
Eligibility Criteria
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
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Combizym-treated group
Bifidobacteri-treated group
Combizym + Bifidobacteri-treated group
control
Arm Description
The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly.
The patients who received polypectomy of colon polyps take Bifidobacteri regularly
The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly
The patients who received polypectomy of colon polyps take no drugs
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02097394
Brief Title
The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps
Official Title
A Randomized Controlled Study on Combizym and Bifidobacteria to Prevent the Recurrence of Colon Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Combizym, Bifidobacteri, Colon Polyps
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combizym-treated group
Arm Type
Active Comparator
Arm Description
The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly.
Arm Title
Bifidobacteri-treated group
Arm Type
Active Comparator
Arm Description
The patients who received polypectomy of colon polyps take Bifidobacteri regularly
Arm Title
Combizym + Bifidobacteri-treated group
Arm Type
Active Comparator
Arm Description
The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly
Arm Title
control
Arm Type
No Intervention
Arm Description
The patients who received polypectomy of colon polyps take no drugs
Intervention Type
Drug
Intervention Name(s)
Combizym
Other Intervention Name(s)
Oryz-Aspergillus Enzyme And Pancreatin Tablet, (provided by Nordmark Arzneimittel GmbH & Co. KG)
Intervention Description
Combizym( 1 tablet, po, tid)
Intervention Type
Drug
Intervention Name(s)
Bifidobacteri
Other Intervention Name(s)
Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules, (produced by Shanghai XinYi Company)
Intervention Description
Bifidobacteri (2 tablet, po, tid)
Intervention Type
Drug
Intervention Name(s)
Combizym + Bifidobacteri
Other Intervention Name(s)
Combizym(Oryz-Aspergillus Enzyme And Pancreatin Tablet), (produced by Nordmark Arzneimittel GmbH & Co. KG), Bifidobacteri(Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules), (produced by Shanghai XinYi Company)
Intervention Description
Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)
Primary Outcome Measure Information:
Title
recurrence of colon polyps
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengliang Chen
Organizational Affiliation
RenJi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps
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