Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
probiotics
A Randomized Controlled Clinical Study of Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
1 other identifier
interventional
40
1 country
1
Brief Summary
Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedStudy Start
First participant enrolled
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 2, 2021
June 1, 2021
1.3 years
June 23, 2021
September 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
grade 3 entiritis
Diarrhea more than seven times a day
one month
Secondary Outcomes (3)
AE
one month
immune index
one month
Changes in intestinal flora
one month
Study Arms (3)
Probiotic group
EXPERIMENTALProbiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention
placebo group
NO INTERVENTIONplacebo( one times a day)with radiotherapy and Chemotherapy Intervention
healthy control group
NO INTERVENTIONhealthy control group
Interventions
Eligibility Criteria
You may qualify if:
- Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our Cancer Center
You may not qualify if:
- any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to Probiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunling Jiang, MD,PHD
radiation department of Jiangxi cancer hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The random assignment of patients was performed by Nanchang Medical University with a computer-generated random number code. Patients were randomly distributed in a 1:1 ratio to receive probiotics or a placebo (the block size was known only to the statistician). The drug was distributed and packaged in accordance with random numbers, and the documents stating the parameters, such as the blinding codes for the seeds of the random numbers, the block length, and the random numbers, were sealed in envelopes
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
September 2, 2021
Study Start
August 27, 2021
Primary Completion
December 27, 2022
Study Completion
December 1, 2024
Last Updated
September 2, 2021
Record last verified: 2021-06