Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer
NCT ID: NCT05570942
Last Updated: 2022-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
56 participants
INTERVENTIONAL
2021-12-07
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Probiotic group
The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics.
Oral Lactobacillus rhamnosus TCELL-1
A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people
Control group
The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo.
Oral Lactobacillus rhamnosus TCELL-1
A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people
Interventions
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Oral Lactobacillus rhamnosus TCELL-1
A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Kai-Wen Huang, PhD
Role: STUDY_DIRECTOR
National Taiwan University Hospital
Locations
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Yu-Tso LIAO
Hsinchu, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202109062RIPD
Identifier Type: -
Identifier Source: org_study_id
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