Akkermansia muciniphila topical probiotic to prevent and treat radiation skin injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, Phase 1, single-arm trial evaluating safety and tolerability of an inactivated AKK topical preparation applied to the radiation field three times daily. About 40 participants will apply the product starting one day before radiotherapy and continuing until 14 days after the last fraction. Primary outcome is the rate of grade 2 or higher acute radiation dermatitis by standard criteria; secondary outcomes include skin microfeatures, microbiota changes, quality of life, and safety. Assessments include baseline skin sampling, digital dermoscopy, and weekly follow-ups during radiotherapy, plus a 14-day post-treatment follow-up. The study aims to establish a preliminary safety profile and gather exploratory data on potential skin health impacts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Cognitive impairment preventing understanding of the study
* Use of antibiotics or antifungals within 1 month
* 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
* 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)
* Use of immunosuppressive drugs
* Symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, tumor invading major vessels or nerves
* Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment)
* Pregnancy or breastfeeding
* 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
* Planned pregnancy from screening until 12 months after last treatment
* Any concomitant condition that, in the investigator's judgment, would compromise patient safety or study completion
* Any other condition deemed unsuitable for enrollment by the investigator
* Inability to provide written informed consent

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Jintang County First People's Hospital
  Chengdu, Sichuan, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.