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Trial Title:
Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer
NCT ID:
NCT05570942
Condition:
Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Arm 1: probiotics group; arm 2: control group (no probiotics; placebo)
Primary purpose:
Other
Masking:
Double (Participant, Investigator)
Masking description:
The patient were given bottle of placebo with same appearance of bottle of probiotics.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Oral Lactobacillus rhamnosus TCELL-1
Description:
A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese
people
Arm group label:
Control group
Arm group label:
Probiotic group
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Yu-Tso LIAO
Address:
City:
Hsinchu
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yu-Tso LIAO
Phone:
+886972654554
Email:
G02386@hch.gov.tw
Start date:
December 7, 2021
Completion date:
December 31, 2022
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05570942
