Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of Oral Lactobacillus Rhamnosus TCELL-1 Upon Colorectal Cancer

Conditions
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Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy

Intervention / Treatment
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* Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: probiotics group; arm 2: control group (no probiotics; placebo)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic group<br>The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics. | Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1<br>* A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people<br>|
| Placebo Comparator: Control group<br>The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo. | Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1<br>* A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of fecal microbiota features | Fecal microbiota composition | 1 year | 
| Change of fecal metabolites | Fecal metabolites such as acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid and isovaleric acid | 1 year | 
| Incidence of adverse events | The adverse events of the probiotics | 1 year | 
| The change of body weight | Changes of body weight from baseline to post-treatment visits | 1 year | 
| 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 | 1 year | 
| The presence of bacteremia | The presence of probiotics-related bacteremia | 1 year |