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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04461782
Other study ID # AB-INTIMUS-Colonization
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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