Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003327269 Date of Approval: 13/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title BV Study
Official scientific title Vaginal colonisation by Lactobacilli in healthy women and women with bacterial vaginosis
Brief summary describing the background and objectives of the trial Bacterial vaginosis (BV) is characterised by a change in the vaginal ecosystem where levels of Lactobacillus species are strikingly reduced, while the proportion of anaerobic micro-organisms like Gardnerella vaginalis, Mycoplasma hominis, Prevotella species, Mobiluncus species and Clostridia species are greatly increased (Fredricks et al., 2005; Ravel et al., 2011). It is regarded as a mild illness but with potentially serious consequences such as preterm births, pelvic inflammatory disease and higher risk of acquiring a sexually transmitted infection including Human Immunodeficiency Virus (HIV) (Cohen et al., 2012; Gosmann et al., 2017; Shin and Kaul, 2008; Wiesendfeld et al., 2003). BV manifests clinically as a thin, whitish, homogeneous vaginal discharge and the presence of an amine odour (Amsel et al., 2003). Supplementation of standard antibiotic therapy with vaginal probiotics could improve the cure rate of BV and reduce the relapse rate in sub-Saharan African countries. Furthermore, a successfully colonising Lactobacillus could be further engineered for delivery of a microbicide (defined as a substance that destroys a microbe of interest, commonly HIV) in the vagina combining both the specificity of the microbicide with the probiotic activity of the lactobacilli. This study tested if a supplement with vaginal EcoVag® capsules can improve the efficacy of the standard treatment of BV in women from Soweto, a township on the outskirts of Johannesburg, South Africa. We also investigated the colonisation by L. gasseri DSM 14869 and L. rhamnosus DSM 14870 in women with normal microbiota and women with BV treated with antibiotics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Bacterial vaginosis,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2013
Actual trial start date 08/10/2014
Anticipated date of last follow up 03/08/2015
Actual Last follow-up date 04/05/2016
Anticipated target sample size (number of participants) 39
Actual target sample size (number of participants) 39
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
M130856 University of the Witwatersrand Human Research Ethics Committee (Medical)
DoH-27-1213-4510 South African National Health Research Ethics Council
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Enrolment was through block randomisation where arm and age were the stratifying variables Allocations were generated by the statistician and allocated sequentially at the clinic Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Women with BV at screening received antibiotics alone (standard of care) cefixime (400 mg stat), doxycycline (100 mg twice daily for 7 days) and metronidazole (2 g stat) 7 days prior to randomisation Antibioitic only Arm 14 Uncontrolled
Experimental Group Healthy women without BV but received vagina Ecovag supplement Vaginal Ecovag supplement daily for 30 days then weekly up to week 190 Daily for 30 days then weekly up to week 190 Ecovag supplementation only 13
Experimental Group Women with BV at screening received antibiotics and Ecovag supplement cefixime (400 mg stat), doxycycline (100 mg twice daily for 7 days) and metronidazole; vaginal Ecovag supplement daily for 30 days then weekly up to week 190 Antibioitic 7 days before enrolment followed by vaginal Ecovag supplement daily for 30 days then weekly up to week 190 Antibiotic and Ecovag 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Females. 18-40 years. Pre-menopausal on menstrual history. Read and understand English. Provide voluntary informed consent. HIV-negative. Intact genital tract. Use Depot Medroxyprogesterone Acetate or norethisterone enanthate injectable contraception for at least 7 days by visit 1 (day 0) Willing to receive HIV testing and counselling Positive for pregnancy test or breastfeeding at study entry. Infected with C. trachomatis or T. vaginalis. History of abnormality on Pap test. Currently using oral contraceptive. Menstruating on enrollment. Did not have sexual debut. Treated with antibiotics within eight weeks of study enrollment. Using oral or vaginal probiotic capsules within eight weeks of enrollment in the study. 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/09/2013 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women colonized by the administered EcoVag¿ Lactobacilli using cultivation and real-time PCR. Day 30-40
Secondary Outcome the proportion of women who are cured from BV and the time from treatment to relapse (if any). Days 30-40
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Perinatal HIV Research Unit Chris Hani Academic Hospital, Soweto Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Swedish Research Council Västra Järnvägsgatan 3 Stockhol SE-111 64 Sweden
Bifodan A/S, Denmark Bogbinderivej 6 Hundested 3390 Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Perinatal HIV Research Unit Chris Hani Academic Hospital, Soweto Johannesburg 1864 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Harold Marcotte Division of Clinical Immunology Department of Laboratory Medicine, Karolinska Institutet Stockholm SE-141 86 Sweden
Per Göran Larsson Department of Obstetrics and Gynaecology Kärnsjukhuset, Skaraborg Hospital Linköping 58183 Sweden
Kasper Krogh Andersen Division of Clinical Immunology, Department of Laboratory Medicine, Karolinska Institutet Stockholm SE-141 86 Sweden
Fanglei Zhuo Division of Clinical Immunology Department of Laboratory Medicine, Karolinska Institutet Stockholm SE-141 86 Sweden
Lennart Hammarström Division of Clinical Immunology Department of Laboratory Medicine, Karolinska Institutet Stockholm SE-141 86 Sweden
Glenda Gray Perinatal HIV Research Unit, Chris Hani Academic Hospital Johannesburg 1864 South Africa
Kishendree Naicker Perinatal HIV Research Unit, Chris Hani Academic Hospital Johannesburg 1864 South Africa
Fatima Laher Perinatal HIV Research Unit, Chris Hani Academic Hospital Perinatal HIV 1864 South Africa
Kennedy Otwombe Perinatal HIV Research Unit, Chris Hani Academic Hospital Perinatal HIV 1864 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatima Laher laherf@phru.co.za +27 11 989 9720 Perinatal HIV Research Unit, Chris Hani Academic Hospital
City Postal code Country Position/Affiliation
Johannesburg 1864 South Africa
Role Name Email Phone Street address
Public Enquiries Kennedy Otwombe otwombek@phru.co.za +27 11 989 9711 Perinatal HIV Research Unit, Chris Hani Academic Hospital
City Postal code Country Position/Affiliation
Johannesburg 1864 South Africa
Role Name Email Phone Street address
Scientific Enquiries Harold Marcotte Harold.Marcotte@ki.se +46 8 5248 3594 Division of Clinical Immunology, Department of Laboratory Medicine, Karolinska Institutet
City Postal code Country Position/Affiliation
Stockholm SE-141 86 Sweden
REPORTING
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