Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy

NCT01473290

Cognitive/Functional Effects Constipation, Impaction, and Bowel Obstruction Diarrhea +4 more

WITHDRAWN PHASE3

The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis

NCT05406882

Radiation Proctitis Probiotics Glutamine +2 more

UNKNOWN PHASE2/PHASE3

Gegen Qinlian Tang and Probiotics for Radiation Enteritis

NCT06836960

Acute Radiation Enteritis

ENROLLING_BY_INVITATION PHASE1/PHASE2

Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)

NCT01706393

Cancer

UNKNOWN NA

Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation

NCT07231588

Radiation Injuries

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radiotherapy Toxicity Diarrhea Probiotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotics

Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.

Group Type EXPERIMENTAL

Bacillus Licheniformis

Intervention Type DRUG

Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.

Placebo

Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bacillus Licheniformis

Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.

Intervention Type DRUG

Placebo

Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biscanen cap. Placebo oral tablet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* History of pelvic irradiation
* Double primary cancer other than skin/thyroid cancer
* Combined serious morbidity
* Experience of other clinical trial within 1 month.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No