Gut Microbiota Modulation via Rectal Ozone: Clinical Study
Clinical Protocol Overview
This clinical study protocol investigates rectal ozone insufflation (ROI) as a therapeutic intervention for managing long-term pelvic toxicity in gynaecological cancer patients following radiotherapy or chemotherapy treatment.
Mechanistic Pathways Under Investigation
The proposed protocol examines whether ROI can reduce inflammation through key molecular pathways including Nrf2 activation and NF-κB inhibition, mechanisms that may help restore microbial balance and improve pelvic symptoms in affected patients.
Supporting Animal Research Evidence
Complementary animal research demonstrates that rectal ozone can increase beneficial bacteria like Lactobacillus and Bifidobacterium, enhance short-chain fatty acids such as butyrate and propionate, and reduce harmful metabolites including TMA and TMAO—changes linked to cardiovascular and gut-barrier health. [frontiersin.org]
Home-Use Therapy Implications
Home-use ozone therapy commentary further supports these findings, suggesting that carefully dosed rectal ozone is unlikely to harm the gut flora and may instead improve mitochondrial activity within the gut barrier, reinforcing its potential as a consistent and accessible therapy for overall gut and systemic wellbeing.
Study Objectives
The primary objectives of this clinical protocol include:
- Assessing changes in gut microbiota composition following ROI treatment
- Measuring inflammatory markers and oxidative stress indicators
- Evaluating patient-reported outcomes for pelvic symptoms and quality of life
- Determining optimal dosing protocols for home-based therapy applications
Download the full clinical study protocol: View Research Paper PDF