Study to assess the preventive effect of new probiotic strain on lactational mastitis.
- Conditions
- Healthy breastfeeding women.
- Registration Number
- NL-OMON25986
- Lead Sponsor
- utricia Research BVUppsalalaan 123508 TC UtrechtNederlandtel + 31 30 2095000
- Brief Summary
ot applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
Healthy pregnant, adults (> 18 years of age);
-Before/during the 35th week of pregnancy;
-Intending to breastfeed her infant;
-Written informed consent.
-Pre-gravid body mass index (BMI)<18 or >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence (hazard) rate of mastitis.
- Secondary Outcome Measures
Name Time Method -Count of recurrent episodes of mastitis;<br>-Incidence (hazard) rate of breastfeeding withdrawal (complete/partial discontinuation).<br>