Clinical Study of Bacillus coagulans Unique IS-2 (ATCC PTA-11748) in the Treatment of Patients with Bacterial Vaginosis.

Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide and is characterized by reduction of native lactobacilli. Antimicrobial therapy used to cure the disease is often found to be ineffective. We postulate that Bacillus coagulans Unique IS-2 (Unique Biotech Limited, India) might provide an appendage to antimicrobial treatment and improve curing rate. In the present study 40 Indian women diagnosed with BV by the presence of symptoms including white discharge, pH greater than 4.7, burning micturation, itching, soreness and redness at vulva. The subjects were divided in 2 groups probiotic (n = 20) and control (n = 20) based on age (control group, 33 ± 3 years and probiotic group, 32.5 ± 3 years), history of previous vaginosis (control group, 75% or 15/20 and probiotic group, 75% or 15/20) and severity of current vaginosis infection (burning micturation and itching, 35% in each group). Probiotic group subjects were assigned to receive a dose of antibiotic therapy [Ofloxacin-Ornidazole with strength of 200-500 mg per capsule/day for 5 days along with vaginal peccaries (co-kimaxazol) for 3 days] simultaneously with two probiotic capsules (10(9) CFUs of Bacillus coagulans Unique IS-2 per capsule). The control group received only antibiotic therapy. At the end of the treatment the 80% of probiotic group subjects showed significant positive response as revealed by reduction of vaginosis symptoms compared to the control group which exhibited reduction in 45% subjects only. Thus, the results of present study indicate that strain Bacillus coagulans Unique IS-2 can provide benefits to women being treated with antibiotics to cure an infectious condition.

RCT Entities:   Population Interventions Outcomes