Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer

Phase 2

• Conditions: Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
• Interventions: Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1

• Registration Number: NCT05570942
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-07
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Oral Lactobacillus rhamnosus TCELL-1	The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics.
Control group	Oral Lactobacillus rhamnosus TCELL-1	The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo.

Primary Outcome Measures

Name	Time	Method
Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version	1 year	THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL)-BREF Taiwan version
Changes in quality of life assessed by EORTC QLQ-CR30	1 year	EORTC QLQ-CR30
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	1 year	The irritable bowel symptoms will be evaluated with the Rome IV criteria of irritable bowel disease

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yu-Tso LIAO; 🇨🇳 Hsinchu, Taiwan