A Randomized open label study of Prebiotics and Probiotics (BIFILAC CAPSULE) in Recurrent Vaginitis as an add on therapy to Standard treatment
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Tablets India Limited
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Efficacy of Prebiotic and probiotic( Bifilac capsule) in reduction of symptoms in Recurrent vaginitis infection as an add on therapy to standard treatment.
Overview
Brief Summary
The composition of urogenital microflora of women is crucial for health and wellbeing of women. Vaginitis is common in women of child bearing age. Recurrent vaginitis is repeat infection within three months of an episode. According to a study, over 50% of those who get vaginitis will recur again within 12 months. Considering the nuts of the problem in terms of women infected per year, urogenital infectious receive far too little attention from scientists, government funding agencies, health professionals, and the pharmaceutical industry. In the complex vaginal environment, bacteria of the lactobacilli group (107-108 CFU g-1 of vaginal fluid) are the dominant microorganisms in healthy pre-menopausal women and play an important protective role by limiting growth of pathogenic microorganisms.When lactobacilli are reduced, eliminated, or replaced by pathogenic species, the host has an increased susceptibility to Urinary Tract infections (UTI), genital tract infections (GTI), bacterial vaginitis(BV),vulvovaginal candidiasis(VVC) and infection by Neisseria gonorrhea or Trichomonas vaginalis.
It is now recognized that the intestinal and urogenital microflora are critical for the health and well-being of humans. The concept of replenishing this flora with probiotic organisms seems to be an option that has a growing scientific basis.
Bifilac capsule is empowered with 3 Prebiotics-streptococcus faecalis T-110 30 million cells, clostridium butyricum 2 million cells, bacillus mesentericus 1 million cells and a Probiotic- lactobacillus sporogenes 50 million. Lactobacillus sporogenes is a universally occurring beneficial bacteria .It is a gram positive, spore-forming lactic acid producing probiotic. Lactobacillus sporogenes ensures proliferation of Lactobacillus in the small intestine. Bifilac thus promotes the growth of both Bifidobacterium in the large intestine as well as Lactobacillus in the small intestine, and thereby completely restores healthy balance of’ intestinal flora. This further harbors the UGT by various hypothesis of travelling of these beneficial micro-organisms via the perennial route. Consequently the uro-genital tract is harbored with probiotics thereby reducing the requirement of standard of care and improving cure rate of vaginitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 58.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women aged 20 years to 58 years suffering from Recurrent vaginitis infections Patients willing to give a written informed consent.
Exclusion Criteria
- •Pregnant and Lactating mother Not willing to give consent Patients with Sulfa drug allergy.
Outcomes
Primary Outcomes
Efficacy of Prebiotic and probiotic( Bifilac capsule) in reduction of symptoms in Recurrent vaginitis infection as an add on therapy to standard treatment.
Time Frame: 8 weeks + 4 months follow up for recurrence
Recurrence rate in the recurrent vaginitis infection
Time Frame: 8 weeks + 4 months follow up for recurrence
Secondary Outcomes
- Causative organism of recurrent vaginitis
Investigators
Dr Poovithaa J
Government Kilpauk Medical College and Hospital