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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01505361

Acronym

PROBIOPREG

Enrollment

100

Registered

2012-01-06

Start date

2011-11-30

Completion date

2012-06-30

Last updated

2012-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mastitis

Keywords

probiotic, Lactobacillus salivarius, mastitis, prevention, group B streptococci, intrapartum prophylaxis

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.

Interventions

BIOLOGICALLactobacillus salivarius PS2

9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth

BIOLOGICALExcipient (milk powder)

100 mg/once a day from 30 week of pregnancy until birth

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts	Weekly during the first 6 months after birth

Secondary

Measure	Time frame
Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab	At weeks 30, 35, 40 of pregnancy

Countries

Spain

Contacts

Primary ContactJuan M Rodríguez, PhD

jmrodrig@vet.ucm.es34913943837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026