Role of Akkermansia Muciniphila in Acne Vulgaris (NCT06992154) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Role of Akkermansia Muciniphila in Acne Vulgaris
34 participantsStarted 2026-03
Plain-language summary
The project explores the use of Pendulum's Glucose Control, which contains a unique combination of probiotics, including Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis, to treat acne by improving gut health and reducing inflammation. These probiotic strains work synergistically to enhance the gut's protective barrier, lower harmful substances such as lipopolysaccharides, and increase the production of beneficial compounds like short-chain fatty acids, which can help modulate immune response and inflammation associated with acne. By integrating this probiotic combination into treatment strategies, the approach aims to offer a natural and effective solution for clearer skin. Additionally, the project seeks to investigate the correlation between postprandial glucose spikes and acne flare-ups. Continuous glucose monitoring (CGM) will be employed to track blood glucose fluctuations following meals, providing valuable insights into the potential link between metabolic responses and acne severity. This comprehensive approach aims to enhance understanding of how gut health, inflammation, and metabolic factors interact in the context of acne management.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants aged 18 to 45 years.
* Individuals with clinically diagnosed moderate to severe acne vulgaris, determined using standardized scales like the Global Acne Grading
* System (GAGS) by Investigators of the study.
* Willingness to provide informed consent and adhere to study protocols, including follow-ups and sample collections.
Exclusion Criteria:
* Recent and/or current antibiotic use: Individuals who have used antibiotics or probiotics within the last three months, as these can alter gut microbiota composition
* Chronic gastrointestinal conditions: Participants with chronic gastrointestinal conditions such as Chron's disease, ulcerative colitis or irritable bowel syndrome (IBS).
* Immune disorders: Individuals with known immune deficiencies or autoimmune diseases, which might affect inflammation levels and study outcomes.
* Pregnancy or Lactation: pregnant or breastfeeding women, due to potential risk and hormonal changes that could influence acne and gut health.
* Inability or unwillingness of subject or legal guardian/representative to give informed consent
* Oral acne medications, including isotretinoin and spironolactone: these medications can significantly alter acne severity, making it difficult to isolate and accurately measure the effects of the probiotic intervention. Isotretinoin, a powerful retinoid, and spironolactone, a hormone-modulating medication, both have well-documented impacts on acne that could confound the study's resu…