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Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
Study Purpose
Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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Inclusion Criteria:
Exclusion Criteria:
- any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to ProbioticsTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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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.
Arms
Experimental: Probiotic group
Probiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention
No Intervention: placebo group
placebo( one times a day)with radiotherapy and Chemotherapy Intervention
No Intervention: healthy control group
healthy control group
Interventions
Other: - probiotics
recieving probiotics at the first day of chemoradiotherapy daily
Contact a Trial Team
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International Sites
Status
Recruiting
Address
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Site Contact
Xiaodan Chen, MD
[email protected]
+8615270865798
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