Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization

Mastitis Clinical Trial

— PROBIOPREG  

Official title:

Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01505361
• Other study ID #: PROBIOPREG
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: January 4, 2012
• Last updated: January 11, 2012
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2012
• Source: Universidad Complutense de Madrid
• Contact: Juan M Rodríguez, PhD
• Phone: 34913943837
• Email: jmrodrig[@]vet.ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• Normal pregnancy

• Healthy women

• Lactational mastitis in, at least, a previous lactation period

• No symptomatic vaginal infections

Exclusion Criteria:

• Any kind of health problems related to pregnancy

• Symptomatic vaginal infections

• Allergy to cow's milk protein

• Intolerance to lactose

• Antibiotic treatment

Related Conditions & MeSH terms

• Mastitis

Intervention

Biological:
• Lactobacillus salivarius PS2
9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth
• Excipient (milk powder)
100 mg/once a day from 30 week of pregnancy until birth

Locations

Country	Name	City	State
Spain	Public Primary Health Care Centers network	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Arroyo R, Martín V, Maldonado A, Jiménez E, Fernández L, Rodríguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763. — View Citation

Jiménez E, Fernández L, Maldonado A, Martín R, Olivares M, Xaus J, Rodríguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts		Weekly during the first 6 months after birth
Secondary	Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab		At weeks 30, 35, 40 of pregnancy

External Links

•   website of the research group