Clinical trial NCT01505361: Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Mastitis
Keywords: probiotic
Lactobacillus salivarius
mastitis
prevention
group B streptococci
intrapartum prophylaxis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
timeFrame: Weekly during the first 6 months after birth
Secondary outcomes:
measure: Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab
timeFrame: At weeks 30, 35, 40 of pregnancy
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Public Primary Health Care Centers network
Study officials:
affiliation: Complutense University of Madrid, Spain
name: Juan M Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez 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.
citation: Jimenez E, Fernandez L, Maldonado A, Martin R, Olivares M, Xaus J, Rodriguez 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.
citation: Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
citation: Fernandez L, Cardenas N, Arroyo R, Manzano S, Jimenez E, Martin V, Rodriguez JM. Prevention of Infectious Mastitis by Oral Administration of Lactobacillus salivarius PS2 During Late Pregnancy. Clin Infect Dis. 2016 Mar 1;62(5):568-573. doi: 10.1093/cid/civ974. Epub 2015 Nov 26.