Cervical CancerNCT07900477
Inactivated KAWAI Bacteria for Diarrhea Prevention During Pelvic Radiotherapy in Postoperative Cervical Cancer
A study testing KAWAI powder in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to evaluate whether an oral probiotic supplement (KAWAI inactivated bacteria) can reduce the side effects (especially diarrhea) caused by pelvic external beam radiation therapy in patients who have undergone surgery… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- KAWAI powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18 to 70 years.
- Histopathologically confirmed cervical cancer, post-surgery, and evaluated based on postoperative pathology to require only pelvic external beam radiotherapy (EBRT).
- ECOG performance status of 0-1.
- Adequate major organ function.
- Provision of written informed consent.
Who cannot join
- Presence of diarrheal symptoms within 2 weeks prior to study initiation; or gastrointestinal diseases that may significantly affect gut microbiota or study results, including: (1) inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis); (2) chronic diarrheal diseases (e.g., diarrhea-predominant irritable bowel syndrome, malabsorption syndrome); (3) active peptic ulcer; (4) history of major gastrointestinal surgery (e.g., subtotal gastrectomy, bowel resection; appendectomy is excluded); (5) other gastrointestinal diseases judged by the investigator to potentially interfere with study results or affect subject safety.
- High-risk factors in postoperative pathology such as positive margins requiring brachytherapy; or lymph node metastasis, parametrial invasion.
- Requirement for concurrent chemotherapy during pelvic EBRT based on postoperative pathology.
- Prior radiotherapy or pelvic malignancies.
- Uncontrolled acute reproductive tract infection.
- Immunosuppressive disease or use of systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 3 months.
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- Use of any probiotics (live or dead), prebiotics, or synbiotics within 1 month.
- Allergy to probiotics or history of severe food allergy.
- Severe heart, liver, kidney, or gastrointestinal diseases.
- Participation in other clinical trials or receipt of investigational drugs/vaccines within 30 days.
- Other factors judged by the investigator that may affect study results or lead to early termination, such as alcoholism, drug abuse, severe comorbidities (including mental illness) requiring concurrent treatment, severe laboratory abnormalities, or family/social factors affecting subject safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral Inactivated KAWAI Bacteria on Adverse Reactions of Postoperative Pelvic External Beam Radiotherapy in Cervical Cancer
This is a multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to evaluate whether an oral probiotic supplement (KAWAI inactivated bacteria) can reduce the side effects (especially diarrhea) caused by pelvic external beam radiation therapy in patients who have undergone surgery for cervical cancer.
Women aged 18 to 70 who have been diagnosed with cervical cancer, have recently undergone surgery, and are scheduled to receive only pelvic external radiation therapy may be eligible to participate. Participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to receive either the KAWAI supplement or a placebo. They will take the study product starting 7 days before radiation therapy and continue until 6 weeks after the radiation therapy ends.
Researchers will closely monitor and compare the occurrence of diarrhea and other side effects between the two groups to see if the KAWAI supplement is safe and effective in improving patients' quality of life during radiotherapy. A total of 100 participants are expected to be enrolled.
Read the detailed description
Background and Rationale:
Pelvic external beam radiotherapy (EBRT) is a standard adjuvant treatment for post-operative cervical cancer patients. However, it often causes acute radiation-induced toxicities, particularly gastrointestinal reactions such as diarrhea, due to the disruption of intestinal and vaginal microecology. Pre-clinical and early clinical data suggest that probiotics, specifically KAWAI inactivated bacteria, may help maintain gut barrier integrity and modulate the immune response. This study aims to evaluate the efficacy and safety of oral KAWAI in reducing radiation-induced toxicities.
Study Design:
This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. A total of 100 eligible patients will be randomized in a 1:1 ratio to either the KAWAI group (N=50) or the placebo group (N=50) using a Central Interactive Web Response System (IWRS).
Intervention:
Experimental Group: Oral KAWAI inactivated bacteria, 4g/day (2g in the morning on an empty stomach, 2g before dinner).
Placebo Group: Oral placebo, matching in appearance, color, smell, and packaging, administered twice daily.
Treatment Duration: Starting 7 days prior to the initiation of pelvic EBRT and continuing until 6 weeks after the completion of EBRT.
Objectives and Endpoints:
Primary Objective: To initially evaluate the efficacy of oral KAWAI in reducing the incidence of acute gastrointestinal toxicity (especially diarrhea) compared to placebo.
Primary Endpoint: The incidence of different grades of diarrhea during pelvic EBRT, assessed according to NCI-CTCAE v5.0.
Secondary Endpoints:
Incidence and severity of other radiotherapy-related adverse reactions (e.g., nausea, vomiting, radiation vaginitis, radiation cystitis).
Longitudinal changes in Quality of Life (QoL) assessed via EORTC QLQ-C30 and QLQ-CX24.
Safety and tolerability of oral KAWAI (incidence of AEs and SAEs).
Exploratory Endpoints:
Changes in gut and vaginal microbiota diversity and composition (via 16S rRNA sequencing).
Changes in systemic inflammatory markers (IL-6, TNF-α) and lymphocyte subsets (CD3+, CD4+, CD8+ T cells).
Inclusion/Exclusion Highlights:
Eligible patients are females aged 18-70 with histopathologically confirmed cervical cancer, post-surgery, requiring only pelvic EBRT (ECOG 0-1). Key exclusion criteria include prior radiotherapy, need for concurrent chemotherapy or brachytherapy, severe gastrointestinal diseases, recent use of probiotics/immunosuppressants, and active uncontrolled infections.
- Conditions
- Cervical Cancer
- Being tested
- KAWAI powder, Placebo
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAWAI powderDietary supplement
Oral administration of inactivated KAWAI bacteria. Dose: 4g/day (4 packets) taken twice daily (2 packets in the morning on an empty stomach, 2 packets before dinner before 4:00 PM). Treatment starts 7 days prior to the initiation of pelvic external beam radiotherapy (EBRT) and continues until 6 weeks after the completion of EBRT.
PlaceboOther
Oral administration of placebo, matching the KAWAI supplement in appearance, color, smell, and packaging. Dose: 2 packets taken twice daily (before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic EBRT and continues until 6 weeks after the completion of EBRT.
| Study group | Role | What they receive |
|---|---|---|
| KAWAI Group | Experimental | Participants receive oral inactivated KAWAI bacteria. Dose: 4g/day (2 packets in the morning on an empty stomach, 2 packets before dinner before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic external beam radiation therapy (EBRT) and continues until 6 weeks after the completion of EBRT. Receives: Dietary Supplement: KAWAI powder |
| Placebo Group | Placebo comparator | Participants receive oral placebo matching the KAWAI supplement in appearance, color, smell, packaging, and administration schedule. Dose: 2 packets twice daily (before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic EBRT and continues until 6 weeks after the completion of EBRT. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Diarrhea (NCI-CTCAE v5.0)
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.
Measured: From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT.
Secondary outcomes (3)
Incidence and Severity of Other Radiation-Induced Toxicities
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.
Measured: From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT.
Quality of Life (QoL) Scores
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).
Measured: Baseline (Day 0), end of EBRT (Week 6), and 3 months after completion of radiotherapy.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: From the time the informed consent is signed until 30 days after the last dose of the study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. Participants are randomly assigned in a 1:1 ratio to either the KAWAI group or the placebo group. The study uses a central interactive web response system (IWRS) for randomization and stratification by center.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keqin Hua, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900477
- Sponsor's protocol ID
- 2025-273-X3
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral Inactivated KAWAI Bacteria on Adverse Reactions of Postoperative Pelvic External Beam Radiotherapy in Cervical Cancer
- ClinicalTrials.gov ID
- NCT07900477
- Acronym / sponsor ID
- 2025-273-X3
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to evaluate whether an oral probiotic supplement (KAWAI inactivated bacteria) can reduce the side effects (especially diarrhea) caused by pelvic external beam radiation therapy in patients who have undergone surgery for cervical cancer.
Women aged 18 to 70 who have been diagnosed with cervical cancer, have recently undergone surgery, and are scheduled to receive only pelvic external radiation therapy may be eligible to participate. Participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to receive either the KAWAI supplement or a placebo. They will take the study product starting 7 days before radiation therapy and continue until 6 weeks after the radiation therapy ends.
Researchers will closely monitor and compare the occurrence of diarrhea and other side effects between the two groups to see if the KAWAI supplement is safe and effective in improving patients' quality of life during radiotherapy. A total of 100 participants are expected to be enrolled.
Detailed description
Background and Rationale:
Pelvic external beam radiotherapy (EBRT) is a standard adjuvant treatment for post-operative cervical cancer patients. However, it often causes acute radiation-induced toxicities, particularly gastrointestinal reactions such as diarrhea, due to the disruption of intestinal and vaginal microecology. Pre-clinical and early clinical data suggest that probiotics, specifically KAWAI inactivated bacteria, may help maintain gut barrier integrity and modulate the immune response. This study aims to evaluate the efficacy and safety of oral KAWAI in reducing radiation-induced toxicities.
Study Design:
This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. A total of 100 eligible patients will be randomized in a 1:1 ratio to either the KAWAI group (N=50) or the placebo group (N=50) using a Central Interactive Web Response System (IWRS).
Intervention:
Experimental Group: Oral KAWAI inactivated bacteria, 4g/day (2g in the morning on an empty stomach, 2g before dinner).
Placebo Group: Oral placebo, matching in appearance, color, smell, and packaging, administered twice daily.
Treatment Duration: Starting 7 days prior to the initiation of pelvic EBRT and continuing until 6 weeks after the completion of EBRT.
Objectives and Endpoints:
Primary Objective: To initially evaluate the efficacy of oral KAWAI in reducing the incidence of acute gastrointestinal toxicity (especially diarrhea) compared to placebo.
Primary Endpoint: The incidence of different grades of diarrhea during pelvic EBRT, assessed according to NCI-CTCAE v5.0.
Secondary Endpoints:
Incidence and severity of other radiotherapy-related adverse reactions (e.g., nausea, vomiting, radiation vaginitis, radiation cystitis).
Longitudinal changes in Quality of Life (QoL) assessed via EORTC QLQ-C30 and QLQ-CX24.
Safety and tolerability of oral KAWAI (incidence of AEs and SAEs).
Exploratory Endpoints:
Changes in gut and vaginal microbiota diversity and composition (via 16S rRNA sequencing).
Changes in systemic inflammatory markers (IL-6, TNF-α) and lymphocyte subsets (CD3+, CD4+, CD8+ T cells).
Inclusion/Exclusion Highlights:
Eligible patients are females aged 18-70 with histopathologically confirmed cervical cancer, post-surgery, requiring only pelvic EBRT (ECOG 0-1). Key exclusion criteria include prior radiotherapy, need for concurrent chemotherapy or brachytherapy, severe gastrointestinal diseases, recent use of probiotics/immunosuppressants, and active uncontrolled infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. Participants are randomly assigned in a 1:1 ratio to either the KAWAI group or the placebo group. The study uses a central interactive web response system (IWRS) for randomization and stratification by center.
| Arm | Type | Receives |
|---|---|---|
| KAWAI Group | Experimental | Dietary Supplement: KAWAI powderParticipants receive oral inactivated KAWAI bacteria. Dose: 4g/day (2 packets in the morning on an empty stomach, 2 packets before dinner before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic external beam radiation therapy (EBRT) and continues until 6 weeks after the completion of EBRT. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants receive oral placebo matching the KAWAI supplement in appearance, color, smell, packaging, and administration schedule. Dose: 2 packets twice daily (before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic EBRT and continues until 6 weeks after the completion of EBRT. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, aged 18 to 70 years.
- Histopathologically confirmed cervical cancer, post-surgery, and evaluated based on postoperative pathology to require only pelvic external beam radiotherapy (EBRT).
- ECOG performance status of 0-1.
- Adequate major organ function.
- Provision of written informed consent.
Key exclusion criteria (11 listed)
- Presence of diarrheal symptoms within 2 weeks prior to study initiation; or gastrointestinal diseases that may significantly affect gut microbiota or study results, including: (1) inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis); (2) chronic diarrheal diseases (e.g., diarrhea-predominant irritable bowel syndrome, malabsorption syndrome); (3) active peptic ulcer; (4) history of major gastrointestinal surgery (e.g., subtotal gastrectomy, bowel resection; appendectomy is excluded); (5) other gastrointestinal diseases judged by the investigator to potentially interfere with study results or affect subject safety.
- High-risk factors in postoperative pathology such as positive margins requiring brachytherapy; or lymph node metastasis, parametrial invasion.
- Requirement for concurrent chemotherapy during pelvic EBRT based on postoperative pathology.
- Prior radiotherapy or pelvic malignancies.
- Uncontrolled acute reproductive tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAWAI powderOral administration of inactivated KAWAI bacteria. Dose: 4g/day (4 packets) taken twice daily (2 packets in the morning on an empty stomach, 2 packets before dinner before 4:00 PM). Treatment starts 7 days prior to the initiation of pelvic external beam radiotherapy (EBRT) and continues until 6 weeks after the completion of EBRT. | Dietary supplement | KAWAI Group |
| PlaceboOral administration of placebo, matching the KAWAI supplement in appearance, color, smell, and packaging. Dose: 2 packets taken twice daily (before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic EBRT and continues until 6 weeks after the completion of EBRT. | Other | Placebo Group |
Primary outcome
Incidence of Diarrhea (NCI-CTCAE v5.0)
Time frame: 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.
3 secondary outcomes
Incidence and Severity of Other Radiation-Induced Toxicities
Time frame: From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT.
Quality of Life (QoL) Scores
Time frame: Baseline (Day 0), end of EBRT (Week 6), and 3 months after completion of radiotherapy.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the time the informed consent is signed until 30 days after the last dose of the study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing KAWAI powder in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keqin Hua, Professor (+86 021 33189900, keqinhuajiaoshou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Diarrhea (NCI-CTCAE v5.0) (time frame: From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.