Role of Akkermansia Muciniphila in Acne Vulgaris

ConditionAcne

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-45

SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule
Dietary supplement
Probiotic capsule will contain Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, and Bifidobacterium Infantis

Treatment groups

34 Participants

are divided into 1 treatment group

Group A: Probiotic GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Acne severity reduction

The primary outcome measure will be the reduction in acne severity from baseline, as assessed by a validated acne severity scoring system (the Global Acne Grading System). Acne severity will be evaluated based on the number, type, and distribution of lesions, as well as the overall clinical assessment of the skin condition. Assessments will be conducted at baseline and specified follow-up intervals to determine the extent of improvement. Reduction in severity will be quantified as a percentage change from baseline scores.

Time frame

12 weeks

Secondary outcomes

Association Between Postprandial Glucose Spikes and Acne Flares

The secondary outcome measure will evaluate the association between postprandial glucose spikes and the frequency or severity of acne flares. Postprandial glucose levels will be monitored using continuous glucose monitoring at designated intervals. Acne flares will be assessed using a validated acne severity scoring system along with participant journals, with flare frequency and changes in lesion count/type recorded over the study period. Correlations between glucose spike magnitude and acne flare characteristics will be analyzed to identify potential relationships.

Time frame

12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Pendulum Therapeutics

Collaborator

Source ClinicalTrials.gov

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