| CTRI Number |
CTRI/2024/07/070646 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Oral Probiotics in Vaginal Candidiasis |
|
Scientific Title of Study
|
Efficacy of oral Probiotic therapy for women with Vulvovaginal Candidiasis:
A randomized controlled study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Aparna |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences,
Bibinagar.
Hyderabad
TELANGANA
508126
India |
| Phone |
8106732587 |
| Fax |
|
| Email |
draparnaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Aparna |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences,
Bibinagar.
Hyderabad
TELANGANA
508126
India |
| Phone |
8106732587 |
| Fax |
|
| Email |
draparnaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Aparna |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences,
Bibinagar.
Hyderabad
TELANGANA
508126
India |
| Phone |
8106732587 |
| Fax |
|
| Email |
draparnaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bibinagar, Hyderabad
TELANGANA, India, Pin: 508126 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bibinagar |
| Address |
All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region, Telangana, India, Pincode: 508126 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparna J |
All India Institute of Medical Sciences, Bibinagar |
out patient ward, Room no 21, Department of OBG, AIIMS Bibinagar, Bhongir district, Hyderbad
Nalgonda
TELANGANA |
8106732587
draparnaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(AIIMS BBN-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Probiotics and standard antifungal therapy |
oral probiotic (Group 1) (2 capsules/day for 5 days followed by further 10 consecutive days at the dosage of 1 capsule/day) and Tab Fluconazole 150mg oral stat |
| Comparator Agent |
Standard antifungal Therapy |
Tab Fluconazole 150mg oral stat) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria: Adult premenopausal women (age 18-50 years), Symptomatic vulvovaginal candidiasis Exclusion Criteria:
Vaginal infections different from VVC, Women treated with other probiotics, pregnancy, lactation, menstruation and a subject’s unwillingness to provide informed consent to participate in the trial. History of systemic organic diseases or psychiatric diseases; Other pathologies (immunodeficiency, diabetes, oestrogen-dependent tumours). Long-term use of contraceptives or immunosuppressants; Use of douching, Anaphylactic constitution or allergic to known ingredients of research drugs.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Vaginal infections different from VVC, Women treated with other probiotics, pregnancy, lactation, menstruation and a subject’s unwillingness to provide informed consent to participate in the trial. History of systemic organic diseases or psychiatric diseases; Other pathologies (immunodeficiency, diabetes, oestrogen-dependent tumours). Long-term use of contraceptives or immunosuppressants; Use of douching, Anaphylactic constitution or allergic to known ingredients of research drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of a multispecies oral probiotic formulation Lactobacillus mixture in combination with bifidobacterium bifidum (capsule combinorm, Abbott Pharma India) given orally as an adjuvant to oral standard antimicrobial therapy in women with symptomatic vulvovaginal candidiasis |
at 2 months after initiating the therapy, if symptoms persists every 2 months until 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluate the recurrence rate in the study population for 6 months |
6 months after initiating therapy |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective randomized single-centre clinical trial. Consenting, eligible women will be randomly allocated to use standard antibiotic therapy plus probiotics (group 1) or only standard antibiotic therapy (group 2). Randomization is created by a computer 1:1 scheme. Treatment will consist of 2 different phases: During the induction phase, all eligible enrolled women with clinical symptoms and signs of VVC such as vulvar burning, vulvar itching, and abnormal vaginal discharge as well as the patients with positive fungal cultures will be included in this study. They will be treated with standard antifungal therapy (Tab Fluconazole 150mg oral stat) and will be randomly assigned to one of two study arms receiving (group 1) for oral probiotic (2 capsules/day for 5 days followed by further 10 consecutive days at the dosage of 1 capsule/day) in the induction phase. Group 2 will receive tab fluconazole 150 mg stat only. During the maintenance phase (a month following the induction phase), group 1 will be given 1 capsule of probiotic per day for 10 consecutive days per month in the premenstrual phase (prophylactic treatment). This timeline is related to the consideration that the recurrence, typically, occurs in the premenstrual or luteal phase, in VVC.All participating women will attend 4 visits (from T0 to T3) at the gynaecological OPD. At recruitment (T0), after the succeeding menstrual cycle (T1), 2 months from T1(T2), and the final visit (T3) at 6 months after the initial visit. In each clinical examination, 2 vaginal swabs are collected. During the first visit (baseline), the patient’s medical history will be recorded, informed consent will be signed, and women will be allocated into the two study arms. Visits from T0 to T3 are to check the efficacy and safety of the investigational product. The symptoms will be evaluated (vaginal discharge, itching) which are self-reported by the patients as present or absent during gynecologic visits. A sample of vaginal secretion will be analyzed for vaginal pH using special pH strips (range 3.8-5.0). Baseline diagnosis of vulvovaginal candidiasis and trichomoniasis are made by routinely used diagnostic procedures |