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


- candidate number15999
- NTR NumberNTR4388
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2014
- Secondary IDsPLB.1.C/B Nutricia Research
- Public TitleStudy to assess the preventive effect of new probiotic strain on lactational mastitis.
- Scientific TitleA randomized, double-blind, placebo-controlled intervention study to assess the preventive effect of new probiotic strain on lactational mastitis.
- ACRONYMPREMIUM
- hypothesisStudy will demonstrate the preventive effect of a new probiotic strain on mastitis in healthy breastfeeding women.
- Healt Condition(s) or Problem(s) studied
- 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- 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, Raynaudí»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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-mrt-2016
- Target number of participants300
- InterventionsIntervention group: probiotic supplement; control group: placebo supplement. Duration of intervention: varies per subject from 16 to 21 weeks.
- Primary outcomeIncidence (hazard) rate of mastitis.
- Secondary outcome- Count of recurrent episodes of mastitis; - Incidence (hazard) rate of breastfeeding withdrawal (complete/partial discontinuation).
- TimepointsVisit 1 screening & baseline; Visit 2 (V2) between week 2 and week 7; Call 1 V2 + 6 weeks; Visit 3 V2+ 12 weeks. In case of (suspected) mastitis additional visits and a call are scheduled.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Mieke Roelofs
- CONTACT for SCIENTIFIC QUERIES Mieke Roelofs
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Nederland B.V.
- PublicationsNot applicable
- Brief summaryIn this study the preventive effect of a new probiotic strain on mastitis in healthy breastfeeding women will be investigated. After screening subjects will receive either the probiotic supplement or the placebo supplement, which they need to take until 12 weeks after delivery. In case no mastitis occurs relevant study information will be collected at several pre-defined time points during the study. In case of a (suspected) mastitis, additional contact moments will be scheduled. During the course of the study at several time points faecal and breast milk samples need to be collected for laboratory analysis.
- Main changes (audit trail)
- RECORD7-jan-2014 - 31-mrt-2014


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