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

Vaginal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461782
• Other study ID #: AB-INTIMUS-Colonization
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: June 2020
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Infection

Intervention

Dietary Supplement:
• Lactobacillus plantarum
Oral food supplement

Locations

Country	Name	City	State
Spain	Sta María del Rosell university hospital	Cartagena

Sponsors (1)

Lead Sponsor	Collaborator
AB Biotics, SA

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. — View Citation

Palacios S, Espadaler J, Fernández-Moya JM, Prieto C, Salas N. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504). Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9. — View Citation

Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonization	Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis	change day 14-23 from baseline
Primary	Colonization	Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis	change day 42 from baseline
Secondary	Lactobacillary grade (LBG) score	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.	change day 42 from baseline
Secondary	Other bacteria in vagina	Detection of other bacteria by metagenomic analysis	change day 14-23 from baseline
Secondary	Other bacteria in vagina	Detection of other bacteria by metagenomic analysis	change day 42 from baseline
Secondary	Vaginal pH	Measured through urine test strip	Change day 14-23 from baseline
Secondary	Vaginal pH	Measured through urine test strip	Change day 42 from baseline
Secondary	Product satisfaction	Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied	day 14-23
Secondary	Safety and tolerability	Analyzed by the number of adverse events registered during the study	through study completion, an average of 42 days
Secondary	Gastrointestinal symptoms	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)	Change day 14-23 from baseline