Back to resultsOral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer
Primary Purpose
Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Oral Lactobacillus rhamnosus TCELL-1
Sponsored by
About this trial
This is an interventional other trial for Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Aged older than 20 years (inclusive) of either gender
- Expressed interest and ability to fulfill the study requirements.
- Be in general good health as determined by the first evaluation within 30 days of the first dose of Lactobacillus Rhamnosus TCELL-1
- Able to ingest the study drug (Lactobacillus Rhamnosus TCELL-1) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube).
- Willing to prevent pregnancy - Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug.
- Willing to comply with protocol and report on compliance and side effects during study period.
- Informed consent obtained and signed prior to screening.
Exclusion Criteria:
- Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
- With uncontrolled infection or serious infection within the past 4 weeks
- Patients who took antibiotics for some reasons within the past 4 weeks
- Patients who must eat probiotics product for some reasons
- Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
- History of allergy to any substance of investigational products
- With known human immunodeficiency virus (HIV) infection
- Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
- With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
- Having participated other investigational study within 4 weeks of entering this study
Sites / Locations
- Yu-Tso LIAORecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic group
Control group
Arm Description
The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics.
The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo.
Outcomes
Primary Outcome Measures
Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL)-BREF Taiwan version
Changes in quality of life assessed by EORTC QLQ-CR30
EORTC QLQ-CR30
Chinese version of EORTC quality of life questionnaire(QLQ)-C30
The Functional Assessment of Cancer Therapy (FACT)-G version 4
Changes in FACT-F version 4 at each post-treatment visit compared to baseline
Changes of irritable bowel symptoms
The irritable bowel symptoms will be evaluated with the Rome IV criteria of irritable bowel disease
Secondary Outcome Measures
Change of fecal microbiota features
Fecal microbiota composition
Change of fecal metabolites
Fecal metabolites such as acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid and isovaleric acid
Incidence of adverse events
The adverse events of the probiotics
The change of body weight
Changes of body weight from baseline to post-treatment visits
Change of serum cytokines
Interleukin (IL)-1, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12, IL-13, IL-15, IL-17, interferon (IFN)-γ, tumor necrotic factor (TNF)-α3
The presence of bacteremia
The presence of probiotics-related bacteremia
Full Information
NCT ID
NCT05570942
First Posted
December 24, 2021
Last Updated
October 6, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05570942
Brief Title
Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer
Official Title
The Effectiveness of Oral Lactobacillus Rhamnosus TCELL-1 Upon Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Emerging evidences have shown that gut microbiota have played roles in the modulation of chemotherapy agents for cancer patients receiving chemotherapy. Probiotics are gut microbiota beneficial to human body. However, little was known about the role of probiotics for cancer patients receiving chemotherapy. Lactobacillus rhamnosus TCELL-1 is a kind of probiotics which were isolated from the gut mucosa of healthy Taiwanese. The aim of the study was to evaluate the effect of Lactobacillus rhamnosus TCELL-1 upon staged III colorectal cancer patients receiving adjuvant chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: probiotics group; arm 2: control group (no probiotics; placebo)
Masking
ParticipantInvestigator
Masking Description
The patient were given bottle of placebo with same appearance of bottle of probiotics.
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic group
Arm Type
Active Comparator
Arm Description
The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Lactobacillus rhamnosus TCELL-1
Intervention Description
A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people
Primary Outcome Measure Information:
Title
Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
Description
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL)-BREF Taiwan version
Time Frame
1 year
Title
Changes in quality of life assessed by EORTC QLQ-CR30
Description
EORTC QLQ-CR30
Time Frame
1 year
Title
Chinese version of EORTC quality of life questionnaire(QLQ)-C30
Time Frame
1 year
Title
The Functional Assessment of Cancer Therapy (FACT)-G version 4
Time Frame
1 year
Title
Changes in FACT-F version 4 at each post-treatment visit compared to baseline
Time Frame
1 year
Title
Changes of irritable bowel symptoms
Description
The irritable bowel symptoms will be evaluated with the Rome IV criteria of irritable bowel disease
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change of fecal microbiota features
Description
Fecal microbiota composition
Time Frame
1 year
Title
Change of fecal metabolites
Description
Fecal metabolites such as acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid and isovaleric acid
Time Frame
1 year
Title
Incidence of adverse events
Description
The adverse events of the probiotics
Time Frame
1 year
Title
The change of body weight
Description
Changes of body weight from baseline to post-treatment visits
Time Frame
1 year
Title
Change of serum cytokines
Description
Interleukin (IL)-1, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12, IL-13, IL-15, IL-17, interferon (IFN)-γ, tumor necrotic factor (TNF)-α3
Time Frame
1 year
Title
The presence of bacteremia
Description
The presence of probiotics-related bacteremia
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged older than 20 years (inclusive) of either gender
Expressed interest and ability to fulfill the study requirements.
Be in general good health as determined by the first evaluation within 30 days of the first dose of Lactobacillus Rhamnosus TCELL-1
Able to ingest the study drug (Lactobacillus Rhamnosus TCELL-1) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube).
Willing to prevent pregnancy - Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug.
Willing to comply with protocol and report on compliance and side effects during study period.
Informed consent obtained and signed prior to screening.
Exclusion Criteria:
Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
With uncontrolled infection or serious infection within the past 4 weeks
Patients who took antibiotics for some reasons within the past 4 weeks
Patients who must eat probiotics product for some reasons
Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
History of allergy to any substance of investigational products
With known human immunodeficiency virus (HIV) infection
Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
Having participated other investigational study within 4 weeks of entering this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Tso Liao, MD
Phone
0972654554
Email
G02386@hch.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Wen Huang, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yu-Tso LIAO
City
Hsinchu
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Tso LIAO
Phone
+886972654554
Email
G02386@hch.gov.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer
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