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Completed

NCT Number: NCT04461782

Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota

Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis.

Probiotics are living organisms that provide the host certain benefits. Despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some Lactobacillus strains in vaginal microbiota. The Lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.

Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. Because of that, this study aims to determine whether this Lactobacillus strain is able to colonize vaginal microbiota when administered orally.

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Key information

Conditions

Vaginal Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sta María del Rosell university hospital

Cartagena, 30203, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asymptomatic subjects with vaginal microbiota classified as LBG (Lactobacillary grade) I, IIa or IIb.
  • Using the same contraceptive within 4 weeks prior to study start.

Exclusion criteria

  • Current vaginal infection.
  • Vaginal infection 1 month prior to study start.
  • Cervico-vaginal pathology.
  • Papilloma human virus.
  • Pregnant or breastfeeding mothers.
  • Using IUD.
  • Immunomodulators or systemic corticoids intake.
  • Vaginal or systemic antibiotics intake 1 month prior to study start.
  • Vaginal probiotic intake 1 month prior to study start.
  • Less than three months after giving birth or abortion.
  • Undergone vaginal or intestinal surgery three months prior to study start.
  • Severe stress or depression.
  • Systemic acute or severe disease.
  • History of alcohol or drug abuse.
  • Chronic intestinal pathology.
  • Not understanding protocol procedures.
  • Use of lubricant 24 hours or spermicide 7 days prior to study start.
  • Swallowing difficulties.
  • Impossibility to understand study procedures.
  • Enrolled in another clinical study.
  • Atrophic vaginitis not under treatment

Treatment and study plan

Lactobacillus plantarum

Dietary Supplement

Oral food supplement

Primary outcomes

  1. Colonization

    Time frame: change day 14-23 from baseline

    Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis

  2. Colonization

    Time frame: change day 42 from baseline

    Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis

Secondary outcomes

  1. Lactobacillary grade (LBG) score

    Time frame: change day 42 from baseline

    obtained by cytology analysis by pathologists and calculated according to Donders et al., 2002. Higher scores imply more severe conditions. Scale ranges from 1 to 3.

  2. Other bacteria in vagina

    Time frame: change day 14-23 from baseline

    Detection of other bacteria by metagenomic analysis

  3. Other bacteria in vagina

    Time frame: change day 42 from baseline

    Detection of other bacteria by metagenomic analysis

  4. Vaginal pH

    Time frame: Change day 14-23 from baseline

    Measured through urine test strip

  5. Vaginal pH

    Time frame: Change day 42 from baseline

    Measured through urine test strip

  6. Product satisfaction

    Time frame: day 14-23

    Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied

  7. Safety and tolerability

    Time frame: through study completion, an average of 42 days

    Analyzed by the number of adverse events registered during the study

  8. Gastrointestinal symptoms

    Time frame: Change day 14-23 from baseline

    Analyzed by the validated Spanish translation of Gastrointestinal Symptom Rating Scale (GSRS) according to Kulich et al., 2005. Score ranges from 0 to 90 where 0 is no symptoms at all and 90 is the highest severity in all symptoms assessed (e.g. pain, bloating, etc)

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Registry information

Official study title

Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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