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

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

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

Study Overview

• Status: Unknown
• Conditions: Colon Polyps; Combizym; Bifidobacteri
• Intervention / Treatment: Drug: Combizym; Drug: Bifidobacteri; Drug: Combizym + Bifidobacteri

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combizym-treated group; The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly.	Drug: Combizym; Combizym( 1 tablet, po, tid); Other Names: Oryz-Aspergillus Enzyme And Pancreatin Tablet; (provided by Nordmark Arzneimittel GmbH & Co. KG)
Active Comparator: Bifidobacteri-treated group; The patients who received polypectomy of colon polyps take Bifidobacteri regularly	Drug: Bifidobacteri; Bifidobacteri (2 tablet, po, tid); Other Names: Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules; (produced by Shanghai XinYi Company)
Active Comparator: Combizym + Bifidobacteri-treated group; The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly	Drug: Combizym + Bifidobacteri; Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid); Other Names: (produced by Shanghai XinYi Company); Combizym(Oryz-Aspergillus Enzyme And Pancreatin Tablet); (produced by Nordmark Arzneimittel GmbH & Co. KG); Bifidobacteri(Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules)
No Intervention: control; The patients who received polypectomy of colon polyps take no drugs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Director: Shengliang Chen, Renji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Intestinal Polyps; Recurrence; Polyps; Colonic Polyps; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: RJYYXHNK-002