Clinical trial NCT05570942: Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer
Official title: The Effectiveness of Oral Lactobacillus Rhamnosus TCELL-1 Upon Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: probiotics group; arm 2: control group (no probiotics; placebo)
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
timeFrame: 1 year
measure: Changes in quality of life assessed by EORTC QLQ-CR30
timeFrame: 1 year
measure: Chinese version of EORTC quality of life questionnaire(QLQ)-C30
timeFrame: 1 year
measure: The Functional Assessment of Cancer Therapy (FACT)-G version 4
timeFrame: 1 year
measure: Changes in FACT-F version 4 at each post-treatment visit compared to baseline
timeFrame: 1 year
measure: Changes of irritable bowel symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Change of fecal microbiota features
timeFrame: 1 year
measure: Change of fecal metabolites
timeFrame: 1 year
measure: Incidence of adverse events
timeFrame: 1 year
measure: The change of body weight
timeFrame: 1 year
measure: Change of serum cytokines
timeFrame: 1 year
measure: The presence of bacteremia
timeFrame: 1 year
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Yu-Tso LIAO
Study officials:
affiliation: National Taiwan University Hospital
name: Kai-Wen Huang, PhD
role: STUDY_DIRECTOR
References: