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Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

NCT ID: NCT01245322

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactobacilli

different lactobacilli.

Group Type ACTIVE_COMPARATOR

lactobacilli

Intervention Type DRUG

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.

Interventions

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lactobacilli

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.

Intervention Type DRUG

Other Intervention Names

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Treatments with differnt lactobacilli two zidovaltreatments

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Skaraborg Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Per-Goran Larsson

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per-Göran Larsson, professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Gynekologklinikken

Drammen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 21854593 (View on PubMed)

Other Identifiers

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LAV-3-BV

Identifier Type: -

Identifier Source: org_study_id