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Clinical Trials/CTRI/2024/03/063844
CTRI/2024/03/063844
Recruiting
Phase 4

A Randomized open label study of Prebiotics and Probiotics (BIFILAC CAPSULE) in Recurrent Vaginitis as an add on therapy to Standard treatment

Tablets India Limited1 site in 1 country100 target enrollmentStarted: March 22, 2024Last updated:

Overview

Phase
Phase 4
Status
Recruiting
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

Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Poovithaa J

Government Kilpauk Medical College and Hospital

Study Sites (1)

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