Radiation enteritis
Conditions
Interventions
Test group:Five-Strain Live Bacteria Capsules (Specification: Each capsule should contain no less than 3×10^9 CFU of live bacteria), 3 times a day, 4 capsules each time, to be taken orally starting fr
Control Group:Placebo, 4 capsules each time, 3 times a day, orally from the first day of radiotherapy until the end of radiotherapy
Sponsors
Hunan academy of traditional Chinese medicine Affiliated hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily sign the informed consent form and be able to follow the requirements of the program procedures; (2) At the time of informed consent, the age was 18 to 75 years old (including the boundary value); (3) Before screening, it is planned to receive abdominal or pelvic radiotherapy with a radiotherapy dose of >=45Gy; (4) When screening, it is expected that the survival time of the clinical research participants will be more than 6 months.
Exclusion criteria
Exclusion criteria: (1) When screening, other diarrhea-related diseases should be combined, such as Crohn's disease, irritable bowel syndrome, antibiotic-associated diarrhea, and acute or chronic gastrointestinal infections (2) When screening, those with intestinal obstruction or immune deficiency (such as HIV infection) (3) At the time of screening, the patient has other uncontrollable diseases, including but not limited to persistent or active infections (4) Patients with gastrostomy or total parenteral nutrition (5) Those who have a history of severe allergic reactions (sudden, life-threatening systemic allergic reactions) to similar drugs (such as Zhengchangsheng, Siliankang, etc.) or other drug components (such as corn starch) in the past (6) Microecological preparations or systemic antibiotics were being used during screening (7) As determined by the researchers, the clinical study participants have other circumstances that interfere with the judgment of the safety and efficacy of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade 3 to 4 diarrhea during radiotherapy (YNMT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Average daily frequency of defecation;Safety Evaluation;Average stool Bristol score;Time from onset of diarrhea to rescue treatment with loperamide, in hours;The occurrence time and duration of radiation enteritis;Abdominal symptom score;The incidence of grade 1 to 2 diarrhea; | — |
Countries
China
Contacts
Public ContactQimei Wang
Hunan academy of traditional Chinese medicine Affiliated hospital
Outcome results
None listed