A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH

NCT05060029 | Unknown Phase 4 FDA Drug

• 1 other identifier: BP/210503/VB/VDPH
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief Summary

Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G. vaginalis and other microbes without affecting lactobacilli. This leads to the treatment of BV while also preventing its recurrence. However, the use of antibiotics may lead to antibiotic resistance and cause various side-effects such as thrush, dizziness, rash, nausea, etc. In the case of many antibiotics, the cure rates were incredibly poor and the BV recurrence rates reached as high as 80 %. Probiotic therapy has slowly been replacing antibiotics for the treatment and prevention of BV and other infections. These probiotics usually contain lactobacilli and help maintain a healthy vaginal environment. They can either be consumed through curd and other milk products that contain probiotics (mostly lactobacilli) or they can be used in the form of suppositories that are placed in the vagina. In probiotics containing lactobacilli, the lactic acid produced by the bacteria lowers the vaginal pH to the ideal range of 3.5 to 4.5 and prevents infection recurrence. Lactobacilli containing suppositories have been successfully used in the past to treat BV, being marketed as a safe and effective way to prevent and treat infections for women in various stages of their lives.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of IP on Vaginal pH

  To evaluate the efficacy of Investigational product (IP) on Vaginal pH as assessed by a pH indicator from baseline to Day 28 in comparison to placebo.

  Day 0 to Day 28

Secondary Outcomes (6)

• Evaluate the efficacy of IP on Vaginal pH

  Day 7 and Day 21

• Evaluate the efficacy of IP on Vaginal Itching

  Day 0, Day 7, Day 21 and Day 28

• Evaluate the efficacy on Microbial Infection control

  Day 0, Day 7, Day 21, and Day 28

• Evaluate the efficacy as per Vaginal Health Index

  Day 0 and Day 28

• Efficacy as per percentage responders in Nugent Score.

  Day 0 and Day 28

Study Arms (2)

Lactobacillus Species Suppositories

EXPERIMENTAL

Coconut oil fatty acids, hyaluronic acid, patented VagiBIOM Probiotic complex CFU (Lactobacillus crispatus Bi16, Lactobacillus gasseri Bi19, Bacillus coagulans Bi34, Lactobacillus acidophilus Bi14) hydrolyzed cellulose, oligofructose, silica gel, lactic acid

Drug: Lactobacillus Species

Coconut Oil Suppositories

PLACEBO COMPARATOR

Coconut oil fatty acid suppositories

Other: Placebo

Interventions

Lactobacillus Species DRUG

Lactobacilli containing suppositories have been successfully used in the past to maintain the vaginal environment and for treatment of infections like BV. Some of the Lactobacilli species that have been used include Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus plantarum, none of which demonstrated any safety concerns. The investigational product, which contains a Lactobacilli complex as its main component, has already been marketed as a tool to maintain vaginal microbial balance, pH and the prevention of microbial infection, thus there are no additional safety concerns or risks involved in this clinical trial design.

Lactobacillus Species Suppositories

Placebo OTHER

Coconut Oil Fatty Acids

Also known as: Coconut Oil

Coconut Oil Suppositories

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant, non-breastfeeding females between the ages of 40 and 65 years, inclusive.
• Participants having at least 3 out of following symptoms or signs:
• Homogeneous, thin, white discharge that smoothly coats the vaginal walls.
• Presence of the clue cells on microscopic examination (as assessed by wet mount test)
• pH of vaginal fluid ≥5
• A fishy odor of vaginal discharge.
• Participants with Nugent score of ≥ 7.
• Participants with a total Vaginal Health Index (VHI) score \<15.
• Participants with pH ≥ 5.
• Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.
• Participants able to comply with and perform the procedures requested by the protocol (including IP compliance, blood sample collection procedures and study visit schedule).
• Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
• Participants able to give written informed consent and willingness to participate in the study and comply with its procedures.

You may not qualify if:

• Participants with signs or symptoms of vaginal or cervical or pelvic or urinary infection on screening or clinical diagnosis of vaginal/cervical/pelvic/ urinary infection in the past 14 days (including but not limited to yeast vulvovaginitis, chlamydia, gonorrhea, trichomonas, genital ulcer disease, pelvic inflammatory disease).
• Participants who are undergoing Hormone Replacement Therapy (HRT).
• Participants on prebiotics or probiotics in the last 1 month.
• Participants who are currently using antibiotics.
• Participants with history/ signs of cervical or vaginal high grade squamous intraepithelial dysplasia (HSIL), atypical glandular cells of uncertain significance (AGUS) or cervical intraepithelial neoplasia.
• Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system.
• Participants who have been diagnosed with polycystic ovary syndrome (PCOS).
• Uncontrolled type II diabetes mellitus (assessed by RBS ≥140 mg/dL.)
• Use of an immunosuppressive or immunomodulatory drug within 6 months prior to enrolment.
• Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg).
• Abnormal Thyroid Stimulating Hormone (TSH) value out of reference range of 0.35 to 5.00 μIU/mL.
• History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
• Participation in other clinical trials in last 3 months prior to screening.
• Smokers (Past smokers can be allowed if they have abstinence for minimum 2 years).
• Chronic or sporadic abdominal pain including moderate to severe dysmenorrhoea.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (5)

JNU Institute for Medical Sciences and Research

Jaipur, Maharashtra, 302017, India

RECRUITING

Shinde Medicare Hospital

Mumbai, Maharashtra, 400058, India

NOT YET RECRUITING

Saraogi Hospital

Mumbai, Maharashtra, 400064, India

NOT YET RECRUITING

Shreenika Hospital

Thane, Maharashtra, 400605, India

RECRUITING

Shubham Sudbhawana Superspeciality Hospital,

Varanasi, Uttar Pradesh, 221005, India

RECRUITING

Related Publications (1)

• Vivekanandan V, Khan ZH, Venugopal G, Musunuru B, Mishra P, Srivastava S, Ramadass B, Subhadra B. VagiBIOM Lactobacillus suppository improves vaginal health index in perimenopausal women with bacterial vaginosis: a randomized control trial. Sci Rep. 2024 Feb 9;14(1):3317. doi: 10.1038/s41598-024-53770-1.

  PMID: 38336815 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Coconut Oil

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Central Study Contacts

Dr. Shalini Srivastava, MD - Med.

CONTACT

+91-22-42172300; shalini.s@vediclifesciences.com

Dr. Sonali Ghosh, BAMS

CONTACT

+91-22-42172300; sonali.g@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In order to preserve the blinding, IP and placebo suppositories will be matched for size, shape, color, and texture. They will be packed in identical fashion in terms of size, color, as well as labelling. The blinding will be done at the CRO (Vedic Lifesciences Pvt. Ltd.). The participant IDs will be arranged in chronological order as per the randomization chart. This chart will be secured, saved and maintained in the electronic Trial Master File (TMF) under the respective project folder.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled study

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 28, 2021
• Study Start: January 3, 2022
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)