Trial · NCT07900477
Inactivated KAWAI Bacteria for Diarrhea Prevention During Pelvic Radiotherapy in Postoperative Cervical Cancer
NCT07900477, Not applicable, Not yet recruiting, Obstetrics & Gynecology Hospital of Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inactivated KAWAI Bacteria for Diarrhea Prevention During Pelvic Radiotherapy in Postoperative Cervical Cancer. Trials, record NCT07900477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07900477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inactivated KAWAI Bacteria for Diarrhea Prevention During Pelvic Radiotherapy in Postoperative Cervical Cancer
- NCT number
- NCT07900477
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Conditions
- Cervical Cancer
- Interventions
- KAWAI powder, Placebo
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Diarrhea (NCI-CTCAE v5.0) | From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT. | To evaluate the incidence of different grades (1-4) of diarrhea during pelvic external beam radiation therapy in postoperative cervical cancer patients. Severity and frequency will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. |
| Secondary | Incidence and Severity of Other Radiation-Induced Toxicities | From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT. | Incidence and severity (Grades 1-4) of other acute radiation-related adverse reactions, including nausea, vomiting, oral mucositis, radiation vaginitis, and radiation cystitis, assessed according to NCI-CTCAE v5.0. |
| Secondary | Quality of Life (QoL) Scores | Baseline (Day 0), end of EBRT (Week 6), and 3 months after completion of radiotherapy. | Longitudinal changes in Quality of Life scores, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the cervical cancer-specific module (QLQ-CX24). |
| Secondary | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the time the informed consent is signed until 30 days after the last dose of the study treatment. | Incidence, severity, and relationship to the study treatment of all Adverse Events (AEs) and Serious Adverse Events (SAEs), evaluated according to NCI-CTCAE v5.0. |
| Other | Changes in Gut/Vaginal Microbiota and Inflammatory Markers | Baseline (Day 0), during EBRT (Week 3), and 3 months after radiotherapy completion. | Exploratory endpoints include changes in the diversity and composition of gut and vaginal microbiota (assessed via 16S rRNA sequencing) and changes in serum inflammatory markers (IL-6, TNF-α) and lymphocyte subsets (CD3+, CD4+, CD8+ T cells) at specific time points before, during, and after treatment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07900477
GET https://conductscience.org/api/trials/v1/NCT07900477/registered