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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04021589
Other study ID # Microbio-WLS001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 11, 2019
Est. completion date October 30, 2021

Study information

Verified date January 2023
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 30, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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: -

Study Design


Intervention

Drug:
Weileshu
a probiotics products which help to rebuild homeostasis of gut microbiome
Chemotherapy
chemotherapy

Locations

Country Name City State
China First affiliated hospital, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression free survival time from randomization to progression up to approximately half a year
Secondary overall survival time from randomization to death up to approximately two years
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