Clinical Research Directory

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 results. Excluding participants using these medications ensures that changes in acne severity can be more directly attributed to the probiotic being tested, leading to clearer, more reliable findings on its efficacy. * History of metabolic disorders such as type 1 diabetes (DM1) and type 2 diabetes (DM2): DM1 and DM2 and their therapies can significantly alter baseline metabolic markers, such as glucose levels, insulin sensitivity, and inflammatory responses. Including such individuals might confound the results and make it difficult to attribute observed effects solely to the probiotics. * Chronic gastrointestinal conditions: Participants with chronic gastrointestinal conditions such as Crohn's disease, ulcerative colitis or irritable bowel syndrome (IBS). * Known hypersensitivity to \>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin * Known hypersensitivity to \>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin * Known allergy or hypersensitivity to any of the following ingredients: Akkermansia muciniphila, Anaerobutyricum hallii, Bifidobacterium infantis, Clostridium beijerinckii, and Clostridium butyricum Other Ingredients: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate (flow agent for encapsulation), and silica. * Immune disorders: Individuals with known immune deficiencies or autoimmune diseases, which might affect inflammation levels and study outcomes. * BMI of greater than or equal to 45: Excess adiposity is likely to impact sex hormones, inflammation, insulin resistance, and GLP-1 levels. These factors could confound the study outcomes. Additionally, excess adiposity is associated with hyperandrogenism and changes in sex hormone-binding globulin (SHBG), which may independently influence acne severity and skew results.