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

Last updated: September 1, 2021
Sponsor: Jiangxi Provincial Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pelvic Cancer

Gastroenteritis

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT05032027
JCL2021-1
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our CancerCenter

Exclusion

Exclusion Criteria:

  • any immune system disease under high risk to antimicrobial agents such asDiabetes,infection disease or drug allergy to Probiotics

Study Design

Total Participants: 40
Study Start date:
August 27, 2021
Estimated Completion Date:
December 01, 2024

Study Description

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.

Connect with a study center

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

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