NCT07635277RecruitingPhase 1
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Clinical Application of AKK Bacterial Preparation for the Treatment of Radiation-Induced Skin Injury
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer (including nasopharyngeal carcinoma). A total of 40 participants are planned to receive the AKK preparation applied to the radiation field three times daily, starting one day before the first radiotherapy fraction and continuing until 14 days after the last fraction. The primary outcome is the incidence of grade ≥2 acute radiation dermatitis (ARD) assessed by RTOG and CTCAE criteria. Secondary outcomes include changes in skin micro-features under digital dermoscopy, skin microbiota composition, quality of life (Skindex-16), and safety.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 7 Jun 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- West China Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07635277
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 7 Jun 2026 to the primary completion date, 30 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with other bacterial preparations
- Participation in other bacterial therapy trials
- Any abnormality (e.g., scar, tattoo) in the radiation field that would interfere with assessment
- Use of immunosuppressive drugs
- Any concomitant condition that, in the investigator's judgment, would compromise patient safety or study completion
Other illness
- Cognitive impairment preventing understanding of the study
- Allergy to probiotics or any component of the study preparation; history of severe allergic reactions (e.g., anaphylaxis, angioedema, respiratory distress, allergic purpura, Arthus reaction)
- Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment)
- Active tuberculosis, bacterial or fungal infection (grade ≥2 per CTCAE), or HIV infection
- Substance abuse or psychiatric disorder
- Active autoimmune disease or history thereof (exceptions: vitiligo, childhood asthma fully resolved with no intervention in adulthood)
- History of alcohol or drug abuse
- Any other condition deemed unsuitable for enrollment by the investigator
Other
- Use of antibiotics or antifungals within 1 month
- Symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, tumor invading major vessels or nerves
- Pregnancy or breastfeeding
- Planned pregnancy from screening until 12 months after last treatment
- Inability to provide written informed consent
Who the study is looking for
- Diagnosis of breast cancer, head and neck cancer (including nasopharyngeal carcinoma) receiving radiotherapy
- Age ≥18 years and ≤75 years, any sex
- Signed written informed consent
- Radiation field skin area can be localized and skin inflammation can be assessed
- ECOG performance status 0-1, life expectancy ≥3 months
- Adequate major organ function
- Fertile patients (both sexes) must use effective medical contraception during the study and for 6 months after the last dose
- Willing to comply with follow-up and skin image collection
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Jintang County First People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.