Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
• Intervention / Treatment: Dietary supplement: Oral Lactobacillus rhamnosus TCELL-1

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yu-Tso Liao, MD; Phone Number: 0972654554; Email: G02386@hch.gov.tw

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • Recruiting
    • Yu-Tso LIAO
    • Contact: Yu-Tso LIAO; Phone Number: +886972654554; Email: G02386@hch.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged older than 20 years (inclusive) of either gender
2. Expressed interest and ability to fulfill the study requirements.
3. Be in general good health as determined by the first evaluation within 30 days of the first dose of Lactobacillus Rhamnosus TCELL-1
4. 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).
5. 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.
6. Willing to comply with protocol and report on compliance and side effects during study period.
7. Informed consent obtained and signed prior to screening.

Exclusion Criteria:

1. Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
2. With uncontrolled infection or serious infection within the past 4 weeks
3. Patients who took antibiotics for some reasons within the past 4 weeks
4. Patients who must eat probiotics product for some reasons
5. Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
6. History of allergy to any substance of investigational products
7. With known human immunodeficiency virus (HIV) infection
8. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
9. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
10. Having participated other investigational study within 4 weeks of entering this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Kai-Wen Huang, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 202109062RIPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No