Clinical Trials associated with Universitas Padjadjaran
NCT06856434
/ Not yet recruitingEarly Phase 1IIT
Effect of Consumption of Lactobacillus Plantarum Sp Probiotics on Leukocyte Levels, Segment Neutrophil Type Counts, Post-operative Pain, and Length of Stay in Patients with Diffuse Peritonitis Due to the Perforated Appendix That Has Been Performed Laparotomy Appendectomy At Dr. Hasan Sadikin Hospital: a Randomized Controlled Trials
Does the administration of the probiotic Lactobacillus plantarum sp. have an impact on reducing leukocyte levels, segmented neutrophil counts, postoperative pain, and length of hospitalization in patients with diffuse peritonitis caused by perforated acute appendicitis who underwent laparotomy appendectomy at Dr. Hasan Sadikin Hospital?
The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment
Background: Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalances in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often rely on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell (MSC) secretomes are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation. Study Design: A phase 2 double-blind randomized controlled trial was adopted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome, and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four mild to moderate acne vulgaris patients were randomly allocated to these groups. Interventions were administered over a period of 8 weeks, with outcomes measured at baseline and post-therapy. This study was conducted at Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome is the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels, and IL-6, to explore the relationship between microbiome balance, skin condition, and inflammation in acne. Discussion: In the context of increasing antibiotic resistance in Indonesia, where therapies often fail to produce sustainable clinical outcomes, this study showed the potential of combining probiotics and MSC secretomes as adjunctive therapies for acne vulgaris. Probiotics restored gut and skin microbiota balance, while MSC secretomes promoted immune modulation and tissue repair. The results of this study paved the way for innovative, non-antibiotic methods for acne management, addressing the need for sustainable and effective therapies amidst growing concerns over dysbiosis and antibiotic resistance.
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.
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