Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy

NCT ID: NCT05032027

Last Updated: 2021-09-02

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2024-12-01

Brief Summary

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Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy.

Detailed Description

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Radiation-induced enteritis is an common and severe side effect of the patients undergoing pelvic radiotherapy. It can lead to dose-limiting and debilitating treatment effect. There is no guideline on an acknowledged intervention that significantly reduces its severity. In previous study, we have abserved that a probiotic combination significantly enhances the immune response of patients and reduces the severity of oral mucositis through modification of gut microbiota. In this stuyd we plan to designe a randomized trial of Probiotics probiotics in patients with pelvic carcinoma.The aim of this study is to determine if regulating intestinal tract flora will reduce the severity of radiation-induced mucositis in patients receiving pelvic radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of grade 3 enteritis. In 2021, 40 patients are estimated to be recruited into the study in Jiangxi Cancer Hospitals, China. 20 patients were randomized to receive Probiotics or placebo during chemoradiotherapy respectively.

Conditions

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Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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

Study Groups

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Probiotic group

Probiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention

Group Type EXPERIMENTAL

probiotics

Intervention Type OTHER

recieving probiotics at the first day of chemoradiotherapy daily

placebo group

placebo( one times a day)with radiotherapy and Chemotherapy Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

healthy control group

healthy control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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probiotics

recieving probiotics at the first day of chemoradiotherapy daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our Cancer Center

Exclusion Criteria

* any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to Probiotics
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chunling Jiang, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

radiation department of Jiangxi cancer hospital

Locations

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Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunling Jiang, MD,PHD

Role: CONTACT

+8613979109200

Xiaodan Chen, PHD

Role: CONTACT

+8615270865798

Facility Contacts

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Xiaodan Chen, MD

Role: primary

+8615270865798

Other Identifiers

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JCL2021-1

Identifier Type: -

Identifier Source: org_study_id

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