Trials Sponsors Conditions Drugs Pricing

Conditions

Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (6)

Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL)-BREF Taiwan version
1 year
Changes in quality of life assessed by EORTC QLQ-CR30
EORTC QLQ-CR30
1 year
Chinese version of EORTC quality of life questionnaire(QLQ)-C30
1 year
The Functional Assessment of Cancer Therapy (FACT)-G version 4
1 year
Changes in FACT-F version 4 at each post-treatment visit compared to baseline
1 year
Changes of irritable bowel symptoms
The irritable bowel symptoms will be evaluated with the Rome IV criteria of irritable bowel disease
1 year

Secondary Outcomes (6)

Change of fecal microbiota features
1 year
Change of fecal metabolites
1 year
Incidence of adverse events
1 year
The change of body weight
1 year
Change of serum cytokines
1 year
+1 more secondary outcomes

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics.

Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1

Control group

PLACEBO COMPARATOR

The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo.

Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1

Interventions

Oral Lactobacillus rhamnosus TCELL-1Dietary supplement

A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people

Control groupProbiotic group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged older than 20 years (inclusive) of either gender
Expressed interest and ability to fulfill the study requirements.

Sponsors & Collaborators

National Taiwan University Hospital
Otherlead

Study Sites (1)

Yu-Tso LIAO

Hsinchu, Taiwan

RECRUITING

Yu-Tso LIAOCONTACT+886972654554 G02386@hch.gov.tw

Study Officials

Kai-Wen Huang, PhD
National Taiwan University Hospital
STUDY DIRECTOR

Central Study Contacts

Yu-Tso Liao, MD

CONTACT

0972654554 G02386@hch.gov.tw

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: The patient were given bottle of placebo with same appearance of bottle of probiotics.
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 24, 2021

First Posted

October 7, 2022

Study Start

December 7, 2021

Actual (reported)

Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (6)

Study Arms (2)

Probiotic group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (6)

Study Arms (2)

Probiotic group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations