Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

NCT ID: NCT04021589

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2021-10-30

Brief Summary

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A total of 50 patients with metastatic colorectal cancer will be enrolled in the study. The patients were randomly divided into the WLS-intervention group and the control group. The two groups of patients were given the most appropriate medication according to the specific conditions of the disease. Patients in the intervention group received additional oral administration of Weileshu, a probiotics product (Tongchuang Biotechnology).

Detailed Description

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Conditions

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Microbial Colonization Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WLS-intervention group

chemotherapy + WLS

Group Type EXPERIMENTAL

Weileshu

Intervention Type DRUG

a probiotics products which help to rebuild homeostasis of gut microbiome

Chemotherapy

Intervention Type DRUG

chemotherapy

the control group

chemotherapy

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type DRUG

chemotherapy

Interventions

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Weileshu

a probiotics products which help to rebuild homeostasis of gut microbiome

Intervention Type DRUG

Chemotherapy

chemotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of colorectal cancer
* Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin \> 9 g/dL Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, \> 50 ml/min calculated by the C-G equation Non-pregnant women of childbearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age) ECOG status ≤ 1 at screening

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Weijia Fang, MD

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weijia Fang, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

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First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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Microbio-WLS001

Identifier Type: -

Identifier Source: org_study_id

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