Study to assess the preventive effect of new probiotic strain on lactational mastitis.

A randomized, double-blind, placebo-controlled intervention study to assess the preventive effect of new probiotic strain on lactational mastitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25986

Enrollment

300

Registered

2014-01-07

Start date

2014-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Healthy breastfeeding women.

Interventions

Intervention group: probiotic supplement

control group: placebo supplement. Duration of intervention: varies per subject from 16 to 21 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: - Healthy pregnant, adults (> 18 years of age); - Before/during the 35th week of pregnancy; - Intending to breastfeed her infant; - Written informed consent.

Exclusion criteria

Exclusion criteria: - Pre-gravid body mass index (BMI)30; - Use of probiotic supplements during the third trimester of current pregnancy; - Enhanced chance of premature delivery (before 37 weeks of gestation); - Current or previous illnesses which could interfere with the study, like other mammary pathologies (e.g. abscesses, Raynaud¡¯s syndrome, breast cancer); - Short bowel syndrome; - Impaired intestinal epithelial barrier (e.g. diarrheal illness, intestinal inflammation); - Serious underlying disease predisposing to infection (e.g. HIV, auto-immune diabetes, multiple organ failure, malignancy, severe burns, severe acute pancreatitis); - Heart failure and cardiac medical history (e.g artificial heart valve, medical history of infectious endocarditis, rheumatic fever and cardiac malformation); - History of aggressive immunosuppressive therapy (e.g. radiotherapy, cancer chemotherapy); - Traumatic injury of the gastro-intestinal tract; - Surgery, including dental surgery, within one month prior to inclusion (V1) ; - Investigator's uncertainty about the willingness/ability of the subject to comply with protocol requirements; - Participation in any other clinical trial within two weeks prior to entry into the study.

Design outcomes

Primary

Measure	Time frame
Incidence (hazard) rate of mastitis.	—

Secondary

Measure	Time frame
- Count of recurrent episodes of mastitis; - Incidence (hazard) rate of breastfeeding withdrawal (complete/partial discontinuation).	—

Contacts

Public ContactMieke Roelofs

PO Box 80141 Nutricia Research BV Uppsalalaan 12

mieke.roelofs@danone.com+31 30 2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)