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

NCT02097394 — Phase 4, Unknown, 200 participants, RenJi Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT02097394
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	200 (Actual)
Sponsor	RenJi Hospital (Other)
Conditions	Combizym, Bifidobacteri, Colon Polyps
Interventions	Combizym, Bifidobacteri, Combizym + Bifidobacteri (Drug)
Dates	start 2013-06-01, primary completion 2020-06-01 (estimated), completion 2020-06-01 (estimated), first posted 2014-03-27, last updated 2020-03-05
Locations	1 site in China

-Summary

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

Expand all sections · Collapse all

+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

+Arms and interventions

Arm	Type	Interventions	Description
Combizym-treated group	Active comparator	Drug: Combizym	The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly.
Bifidobacteri-treated group	Active comparator	Drug: Bifidobacteri	The patients who received polypectomy of colon polyps take Bifidobacteri regularly
Combizym + Bifidobacteri-treated group	Active comparator	Drug: Combizym + Bifidobacteri	The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly
control	No intervention		The patients who received polypectomy of colon polyps take no drugs

Combizym (Drug), also known as Oryz-Aspergillus Enzyme And Pancreatin Tablet, (provided by Nordmark Arzneimittel GmbH & Co. KG): Combizym( 1 tablet, po, tid)
Bifidobacteri (Drug), also known as Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules, (produced by Shanghai XinYi Company): Bifidobacteri (2 tablet, po, tid)
Combizym + Bifidobacteri (Drug), 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( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)

+Outcome measures

Primary outcomes

recurrence of colon polyps [one year]: The whole patients need be examined by colonoscopy one year later. The recurrence rate of colon polyps will be acquired in different arms

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Renji Hospital	Shanghai, Shanghai Municipality	China

+Investigators

Shengliang Chen, Study director, RenJi Hospital