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

• Sponsor: AB Biotics, SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04461782
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Infection	Dietary Supplement: Lactobacillus plantarum	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota
• Actual Study Start Date: Apr 15, 2019
• Actual Primary Completion Date: Feb 15, 2020
• Actual Study Completion Date: Feb 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus plantarum Oral intake 1 cap daily 1E+09 cfu/cap of Lactobacillus plantarum	Dietary Supplement: Lactobacillus plantarum; Oral food supplement

Outcome Measures

Primary Outcome Measures

1. Colonization [change day 14-23 from baseline]

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

2. Colonization [change day 42 from baseline]

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

Secondary Outcome Measures

1. Lactobacillary grade (LBG) score [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 [change day 14-23 from baseline]

   Detection of other bacteria by metagenomic analysis

3. Other bacteria in vagina [change day 42 from baseline]

   Detection of other bacteria by metagenomic analysis

4. Vaginal pH [Change day 14-23 from baseline]

   Measured through urine test strip

5. Vaginal pH [Change day 42 from baseline]

   Measured through urine test strip

6. Product satisfaction [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 [through study completion, an average of 42 days]

   Analyzed by the number of adverse events registered during the study

8. Gastrointestinal symptoms [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sta María del Rosell university hospital	Cartagena		Spain	30203

Sponsors and Collaborators

• AB Biotics, SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8.
• 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.
• Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. Review.

• Responsible Party: AB Biotics, SA
• ClinicalTrials.gov Identifier: NCT04461782
• Other Study ID Numbers: AB-INTIMUS-Colonization
• First Posted: Jul 8, 2020
• Last Update Posted: Jul 8, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AB Biotics, SA: vaginal probiotic

Study Results

No Results Posted as of Jul 8, 2020