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Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

Primary Purpose

Bacterial Vaginosis

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

lactobacilli

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring treatment, lactobacilli

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections.

Exclusion Criteria:

Exclusion criteria were patients with hormonal IUD without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection

Sites / Locations

Gynekologklinikken

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Lactobacilli

Arm Description

different lactobacilli.

Outcomes

Primary Outcome Measures

characterize lactobacilli of human vaginal origin

Secondary Outcome Measures

cure rate after 24 month

to investigate if more extended antibiotic treatment against BV, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

Full Information

NCT ID

NCT01245322

First Posted

November 19, 2010

Last Updated

November 6, 2014

Sponsor

Skaraborg Hospital

Collaborators

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01245322

Brief Title

Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

Official Title

Extended Antimicrobial Treatment of Bacterial Vaginosis Combined With Human Lactobacilli to Find the Best Treatment and Minimize the Risk of Relapses

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Skaraborg Hospital

Collaborators

Karolinska University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

Detailed Description

Nine of the vaginal Lactobacillus strains isolated from healthy Swedish women and characterized in the present study were selected for the clinical trial.All women with symptomatic BV fulfilling the inclusion criteria were consecutively offered to participate in a prospective study of adjuvant lactobacilli given in addition to antibiotics. Women included were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. Exclusion criteria were patients with hormonal intrauterine device without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Vaginosis

Keywords

treatment, lactobacilli

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactobacilli

Arm Type

Active Comparator

Arm Description

different lactobacilli.

Intervention Type

Drug

Intervention Name(s)

lactobacilli

Other Intervention Name(s)

Treatments with differnt lactobacilli two zidovaltreatments

Intervention Description

women were given a seven days course of daily 2% vaginal clindamycin cream (Dalacin vaginal cream 2%, Pfizer Norway Ltd) together with oral clindamycin 300 mg BID for 7 days (Dalacin 300 mg, Pfizer Norway Ltd). Oral clindamycin treatment was also given to the patient's sexual partner.

Primary Outcome Measure Information:

Title

characterize lactobacilli of human vaginal origin

Description

characterize lactobacilli of human vaginal origin

Time Frame

24 month

Secondary Outcome Measure Information:

Title

cure rate after 24 month

Description

Time Frame

24 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. Exclusion Criteria: Exclusion criteria were patients with hormonal IUD without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per-Göran Larsson, professor

Organizational Affiliation

Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gynekologklinikken

City

Drammen

ZIP/Postal Code

3002

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

21854593

Citation

Larsson PG, Brandsborg E, Forsum U, Pendharkar S, Andersen KK, Nasic S, Hammarstrom L, Marcotte H. Extended antimicrobial treatment of bacterial vaginosis combined with human lactobacilli to find the best treatment and minimize the risk of relapses. BMC Infect Dis. 2011 Aug 19;11:223. doi: 10.1186/1471-2334-11-223.

Results Reference

derived

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Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

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