| Title |
Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial
|
|---|---|
| Published in |
Drug Design, Development and Therapy, September 2015
|
| DOI | 10.2147/dddt.s89214 |
| Pubmed ID | |
| Authors |
Anna Tomusiak, Magdalena Strus, Piotr B Heczko, Paweł Adamski, Grzegorz Stefański, Aleksandra Mikołajczyk-Cichońska, Magdalena Suda-Szczurek |
| Abstract |
The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. The study was a multicenter, randomized, double-blind, and placebo-controlled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4-6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag(®), or a placebo (one capsule for seven consecutive days vaginally). The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Administration of inVag contributed to a significant decrease (between visits) in both vaginal pH (P<0.05) and Nugent score (P<0.05), and a significant increase in the abundance of Lactobacillus between visit I and visits III and IV (P<0.05). Molecular typing revealed the presence of Lactobacillus strains originating from inVag in 82% of women taking the drug at visit III, and 47.5% at visit IV. There was no serious adverse event related to inVag administration during the study. The probiotic inVag is safe for administration to sustainably restore the healthy vaginal microbiota, as demonstrated by predominance of the Lactobacillus bacteria in vaginal microbiota. |
X Demographics
The data shown below were collected from the profiles of 5 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 2 | 40% |
| Unknown | 3 | 60% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 2 | 40% |
| Members of the public | 2 | 40% |
| Scientists | 1 | 20% |
Mendeley readers
The data shown below were compiled from readership statistics for 123 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 123 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 19 | 15% |
| Student > Master | 18 | 15% |
| Student > Bachelor | 16 | 13% |
| Other | 13 | 11% |
| Student > Ph. D. Student | 12 | 10% |
| Other | 16 | 13% |
| Unknown | 29 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 26 | 21% |
| Pharmacology, Toxicology and Pharmaceutical Science | 15 | 12% |
| Immunology and Microbiology | 12 | 10% |
| Agricultural and Biological Sciences | 9 | 7% |
| Biochemistry, Genetics and Molecular Biology | 7 | 6% |
| Other | 15 | 12% |
| Unknown | 39 | 32% |
Attention Score in Context
This research output has an Altmetric Attention Score of 11. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 11 May 2021.
All research outputs
#3,222,298
of 25,374,647 outputs
Outputs from Drug Design, Development and Therapy
#180
of 2,268 outputs
Outputs of similar age
#40,154
of 276,791 outputs
Outputs of similar age from Drug Design, Development and Therapy
#7
of 133 outputs
Altmetric has tracked 25,374,647 research outputs across all sources so far. Compared to these this one has done well and is in the 87th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 2,268 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.1. This one has done particularly well, scoring higher than 91% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 276,791 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 85% of its contemporaries.
We're also able to compare this research output to 133 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 93% of its contemporaries.