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

NCT02097394 | Unknown Phase 4 DMC

• 1 other identifier: RJYYXHNK-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Combizym; Bifidobacteri; Colon Polyps

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Combizym-treated group

ACTIVE COMPARATOR

The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly.

Drug: Combizym

Bifidobacteri-treated group

ACTIVE COMPARATOR

The patients who received polypectomy of colon polyps take Bifidobacteri regularly

Drug: Bifidobacteri

Combizym + Bifidobacteri-treated group

ACTIVE COMPARATOR

The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly

Drug: Combizym + Bifidobacteri

control

NO INTERVENTION

The patients who received polypectomy of colon polyps take no drugs

Interventions

Combizym DRUG

Combizym( 1 tablet, po, tid)

Also known as: Oryz-Aspergillus Enzyme And Pancreatin Tablet, (provided by Nordmark Arzneimittel GmbH & Co. KG)

Combizym-treated group

Bifidobacteri DRUG

Bifidobacteri (2 tablet, po, tid)

Also known as: Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules, (produced by Shanghai XinYi Company)

Bifidobacteri-treated group

Combizym + Bifidobacteri DRUG

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

Also known as: 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)

Combizym + Bifidobacteri-treated group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis

You may not qualify if:

• have organic or other functional disease
• pregnant or breast-feeding

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Combizym; Pancreatin

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

• Shengliang Chen

  RenJi Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor,chief physician

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: March 27, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

CN (1)