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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Colon Polyps; Bifidobacteri; Combizym

Treatments: Drug: Combizym + Bifidobacteri; Drug: Combizym; Drug: Bifidobacteri

Study type: Interventional

Funder types: Other

Identifiers

NCT02097394

RJYYXHNK-002

Details and patient eligibility

About

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

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Combizym-treated group

Active Comparator group

Description:

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

Treatment:

Drug: Combizym

Bifidobacteri-treated group

Active Comparator group

Description:

The patients who received polypectomy of colon polyps take Bifidobacteri regularly

Treatment:

Drug: Bifidobacteri

Combizym + Bifidobacteri-treated group

Active Comparator group

Description:

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

Treatment:

Drug: Combizym + Bifidobacteri

control

No Intervention group

Description:

The patients who received polypectomy of colon polyps take no drugs