RadiotherapyPhase 3NCT03978949
Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)
A Phase 3 study testing Bacillus Licheniformis in people with Radiotherapy and Toxicity, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Radiotherapy, Toxicity, Diarrhea
- What is being tested?
- Bacillus Licheniformis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2019to 31 Aug 2024
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer
- Over 20 years of age
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3
- Appropriate values of kidney function within 6 months after enrollment Creatinin < 2.0 ng/dL
- Appropriate values of liver function within 6 months after enrollment Total bilirubin < 1.5 times upper limit normal range, alanine aminotransferase or aspartate aminotransferase < 2.5 times upper limit normal range.
- Willing to provide informed written consent
Who cannot join
- History of pelvic irradiation
- Double primary cancer other than skin/thyroid cancer
- Combined serious morbidity
- Experience of other clinical trial within 1 month.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Young Seok Kim, M.D., Ph.D., 82 2 3010 5614 ext. 5614, ysk@amc.seoul.kr
About this study
Official title: Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study
In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.
- Conditions
- Radiotherapy, Toxicity, Diarrhea, Probiotics
- Being tested
- Bacillus Licheniformis, Placebo
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus LicheniformisDrug
Also called Biscanen cap.
Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
PlaceboDrug
Also called Placebo oral tablet
Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy. Receives: Drug: Bacillus Licheniformis |
| Placebo | Placebo comparator | Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with grade 2 or more acute intestinal toxicities
Evaluation using CTCAE version 4.0
Measured: Adverse effect evaluated at 3 months after radiation therapy
Secondary outcomes (1)
Number of participants with grade 2 or more chronic intestinal toxicities
Evaluation using CTCAE version 4.0
Measured: Adverse effect occured after 3 months since end of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jun 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Seok Kim, Asan Medical Center
- Investigators
- Young Seok Kim, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978949
- Sponsor's protocol ID
- S2019-0657-0003
- Status last verified
- Jan 2021
- First submitted
- 31 May 2019
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jo YY, Kim YJ, Lee SH, Kim YS. Prevention of Radiotherapy-Induced Enteropathy by Probiotics (PREP): Double-Blind Randomized Placebo-Controlled Trial. Curr Oncol. 2024 Oct 1;31(10):5889-5895. doi: 10.3390/curroncol31100438.
PubMed 39451742Kim YJ, Yu J, Park SP, Lee SH, Kim YS. Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial. BMC Cancer. 2021 Sep 16;21(1):1032. doi: 10.1186/s12885-021-08757-w.
PubMed 34530750
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study
- ClinicalTrials.gov ID
- NCT03978949
- Acronym / sponsor ID
- S2019-0657-0003
- Conditions
- Radiotherapy, Toxicity, Diarrhea, Probiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 7 Jun 2019 (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.
In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Drug: Bacillus LicheniformisTwo weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy. |
| Placebo | Placebo comparator | Drug: PlaceboTwo weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer
- Over 20 years of age
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3
- Appropriate values of kidney function within 6 months after enrollment Creatinin < 2.0 ng/dL
Key exclusion criteria (4 listed)
- History of pelvic irradiation
- Double primary cancer other than skin/thyroid cancer
- Combined serious morbidity
- Experience of other clinical trial within 1 month.
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 |
|---|---|---|
| Bacillus LicheniformisAlso: Biscanen cap.Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy. | Drug | Probiotics |
| PlaceboAlso: Placebo oral tabletTwo weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy. | Drug | Placebo |
Primary outcome
Number of participants with grade 2 or more acute intestinal toxicities
Time frame: Adverse effect evaluated at 3 months after radiation therapy
Evaluation using CTCAE version 4.0
1 secondary outcome
Number of participants with grade 2 or more chronic intestinal toxicities
Time frame: Adverse effect occured after 3 months since end of radiation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 39451742Jo YY, Kim YJ, Lee SH, Kim YS. Prevention of Radiotherapy-Induced Enteropathy by Probiotics (PREP): Double-Blind Randomized Placebo-Controlled Trial. Curr Oncol. 2024 Oct 1;31(10):5889-5895. doi: 10.3390/curroncol31100438.
- Derived from this study: PubMed 34530750Kim YJ, Yu J, Park SP, Lee SH, Kim YS. Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial. BMC Cancer. 2021 Sep 16;21(1):1032. doi: 10.1186/s12885-021-08757-w.
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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.
Young Seok Kim, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bacillus Licheniformis in people with Radiotherapy and Toxicity, run by Asan Medical Center at 1 site in South Korea.
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 4 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 19 Jan 2021. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Young Seok Kim, M.D., PhD. (82 2 3010 5614 ext. 5614, ysk@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with grade 2 or more acute intestinal toxicities (time frame: Adverse effect evaluated at 3 months after radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978949, which also lists 2 linked publications.
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 19 Jan 2021.