Radiation Enteritis
Conditions
Interventions
Trial group 1 (low dose):KAL-002 (Specification 1: viable bacteria count per capsule should be no less than 2.5×10^8 CFU), taken orally 3 times daily, 3 capsules each time, starting from day 1 of radi
Trial group 2 (high dose):KAL-002 (Specification 2: viable bacteria count per capsule should be no less than 3.0×10^9 CFU), taken orally 3 times daily, 3 capsules each time, starting from day 1 of rad
Control group (placebo):Placebo (gelatin capsule placebo, containing only excipient corn starch, no viable bacteria), taken orally 3 times daily, 3 capsules each time, starting from day 1 of radiother
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.At the time of informed consent, the age was 18 to 75 years old (including the boundary value).; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1 (see Appendix 2 for details); 3. Expected survival time of more than 6 months at screening; 4. At screening, diagnosed with cervical cancer, endometrial cancer, bladder cancer, prostate cancer, or colorectal cancer, and planned to receive pelvic radiotherapy with a total dose of >=45 Gy, at a schedule of 5 fractions per week, with a dose of 1.6 Gy to 2.5 Gy per fraction, over a radiotherapy duration of 5 to 6 weeks; 5. For participants with prior anti-tumor therapy, prior treatment-related adverse events shall be Grade 1 or below (per CTCAE Version 5.0) as assessed by the investigator, or deemed without safety risks (e.g., alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.) at screening; 6. Participants of childbearing potential (male and female) agree to use reliable contraceptive measures during the trial period and for 3 months after drug discontinuation (abstinence from sexual activity or consistent barrier contraception with condoms); 7. Voluntarily sign the informed consent form, be able to communicate well with the investigators, and comply with the requirements of the study protocol procedures.
Exclusion criteria
Exclusion criteria: 1. With a prior history of pelvic radiotherapy; 2. Those who have received irinotecan within 1 week prior to screening or require irinotecan administration during the trial; 3. Underwent intestinal resection and was assessed by the investigator as having intestinal dysfunction (e.g., intestinal adhesions) that makes them unsuitable for participation in the study; 4. Patients with gastrointestinal stoma or receiving total parenteral nutrition; 5. Those presenting with diarrhea or complicated with other diarrhea-related diseases at screening, such as Crohn’s disease, ulcerative colitis, irritable bowel syndrome, etc.; 6. Those with antibiotic-associated diarrhea, gastrointestinal infection, etc. within 4 weeks prior to screening; 7. Those with chronic constipation at screening who have used laxatives at least once per week on average in the past 3 months; 8. Those complicated with intestinal obstruction at screening; 9. Human Immunodeficiency Virus (HIV) infected individuals at screening; 10. Those with fever or active infection (e.g., active hepatitis B, hepatitis C, etc.) at screening; 11. Those with a history of severe allergy (immediate, life-threatening systemic allergic reaction) to similar drugs (e.g., Bacillus Licheniformis Capsules, Bifidobacterium Tetragenous Tablets, etc.) or other drug ingredients (e.g., corn starch); 12. Those who have participated in another clinical trial and received investigational drugs or devices within 1 month prior to screening; 13. Those who have used microecological preparations or systemic antibiotics within 1 week prior to screening; 14. Females who are pregnant/lactating or have a positive blood pregnancy test at screening; 15. Those with alcoholism, drug addiction or substance abuse that may interfere with the evaluation of trial results; 16. Patients with mental illness or cognitive dysfunction who are unable to complete the diary card accurately; 17. Participants with any other conditions deemed by the investigator to interfere with the safety and efficacy evaluation of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade 2–4 radiation enteritis related diarrhea during the study period;Safety outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean daily bowel movement frequency;Mean number of days and episodes of Bristol stool type 6/7;Incidence of radiation enteritis-related abdominal pain, diarrhea, and hematochezia;Mean number of days with grade >=2 radiation enteritis-related diarrhea;Mean number of days of radiation enteritis-related diarrhea;Time to onset of radiation enteritis-related diarrhea; | — |
Countries
China
Contacts
Public ContactLiu Hong
Qilu Hospital of Shandong University
Outcome results
None listed