Staged III Colorectal Cancer Receiving Adjuvant ChemotherapyPhase 2NCT05570942
Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer
A Phase 2 study testing Oral Lactobacillus rhamnosus TCELL-1 in people with Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy
- What is being tested?
- Oral Lactobacillus rhamnosus TCELL-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2021to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged older than 20 years (inclusive) of either gender
- Expressed interest and ability to fulfill the study requirements.
- Be in general good health as determined by the first evaluation within 30 days of the first dose of Lactobacillus Rhamnosus TCELL-1
- 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).
- 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.
- Willing to comply with protocol and report on compliance and side effects during study period.
- Informed consent obtained and signed prior to screening.
Who cannot join
- Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
- With uncontrolled infection or serious infection within the past 4 weeks
- Patients who took antibiotics for some reasons within the past 4 weeks
- Patients who must eat probiotics product for some reasons
- Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
- History of allergy to any substance of investigational products
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- With known human immunodeficiency virus (HIV) infection
- Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
- With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
- Having participated other investigational study within 4 weeks of entering this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yu-Tso LIAO
Hsinchu
Yu-Tso LIAO, +886972654554, G02386@hch.gov.tw
About this study
Official title: 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.
- Being tested
- Oral Lactobacillus rhamnosus TCELL-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Lactobacillus rhamnosus TCELL-1Dietary supplement
A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics. Receives: Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1 |
| Control group | Placebo comparator | The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo. Receives: Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL)-BREF Taiwan version
Measured: 1 year
Changes in quality of life assessed by EORTC QLQ-CR30
EORTC QLQ-CR30
Measured: 1 year
Chinese version of EORTC quality of life questionnaire(QLQ)-C30
Measured: 1 year
The Functional Assessment of Cancer Therapy (FACT)-G version 4
Measured: 1 year
Changes in FACT-F version 4 at each post-treatment visit compared to baseline
Measured: 1 year
Changes of irritable bowel symptoms
The irritable bowel symptoms will be evaluated with the Rome IV criteria of irritable bowel disease
Measured: 1 year
Secondary outcomes (6)
Change of fecal microbiota features
Fecal microbiota composition
Measured: 1 year
Change of fecal metabolites
Fecal metabolites such as acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid and isovaleric acid
Measured: 1 year
Incidence of adverse events
The adverse events of the probiotics
Measured: 1 year
The change of body weight
Changes of body weight from baseline to post-treatment visits
Measured: 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
Measured: 1 year
The presence of bacteremia
The presence of probiotics-related bacteremia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start7 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staged III Colorectal Cancer Receiving Adjuvant ChemotherapyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: probiotics group; arm 2: control group (no probiotics; placebo)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570942
- Sponsor's protocol ID
- 202109062RIPD
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Lactobacillus Rhamnosus TCELL-1 Upon Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05570942
- Acronym / sponsor ID
- 202109062RIPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Arm 1: probiotics group; arm 2: control group (no probiotics; placebo)
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given probiotics. |
| Control group | Placebo comparator | Dietary Supplement: Oral Lactobacillus rhamnosus TCELL-1The patients with staged III colorectal cancer receiving adjuvant chemotherapy who will be given placebo. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged older than 20 years (inclusive) of either gender
- Expressed interest and ability to fulfill the study requirements.
- Be in general good health as determined by the first evaluation within 30 days of the first dose of Lactobacillus Rhamnosus TCELL-1
- 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).
- 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.
Key exclusion criteria (10 listed)
- Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
- With uncontrolled infection or serious infection within the past 4 weeks
- Patients who took antibiotics for some reasons within the past 4 weeks
- Patients who must eat probiotics product for some reasons
- Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Lactobacillus rhamnosus TCELL-1A kind of probiotics which was isolated from the intestinal mucosa of health Taiwanese people | Dietary supplement | Control group, Probiotic group |
Primary outcome
Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
Time frame: 1 year
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL)-BREF Taiwan version
Changes in quality of life assessed by EORTC QLQ-CR30
Time frame: 1 year
EORTC QLQ-CR30
Chinese version of EORTC quality of life questionnaire(QLQ)-C30
Time frame: 1 year
The Functional Assessment of Cancer Therapy (FACT)-G version 4
Time frame: 1 year
Changes in FACT-F version 4 at each post-treatment visit compared to baseline
Time frame: 1 year
Changes of irritable bowel symptoms
Time frame: 1 year
The irritable bowel symptoms will be evaluated with the Rome IV criteria of irritable bowel disease
6 secondary outcomes
Change of fecal microbiota features
Time frame: 1 year
Change of fecal metabolites
Time frame: 1 year
Incidence of adverse events
Time frame: 1 year
The change of body weight
Time frame: 1 year
Change of serum cytokines
Time frame: 1 year
The presence of bacteremia
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai-Wen Huang, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Lactobacillus rhamnosus TCELL-1 in people with Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Tso Liao, MD (0972654554, G02386@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.