Study will demonstrate the preventive effect of a new probiotic strain on mastitis in healthy breastfeeding women.
ID
Bron
Verkorte titel
Aandoening
Healthy breastfeeding women.
Ondersteuning
Uppsalalaan 12
3508 TC Utrecht
Nederland
tel + 31 30 2095000
Uppsalalaan 12
3508 TC Utrecht
Nederland
tel + 31 30 2095000
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Incidence (hazard) rate of mastitis.
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
Study will demonstrate the preventive effect of a new probiotic strain on mastitis in healthy breastfeeding women.
Onderzoeksopzet
Visit 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.
Onderzoeksproduct en/of interventie
Intervention group: probiotic supplement; control group: placebo supplement.
Duration of intervention: varies per subject from 16 to 21 weeks.
Publiek
Nutricia Research BV
Uppsalalaan 12
Mieke Roelofs
Utrecht 3508 TC
The Netherlands
+31 30 2095000
mieke.roelofs@danone.com
Wetenschappelijk
Nutricia Research BV
Uppsalalaan 12
Mieke Roelofs
Utrecht 3508 TC
The Netherlands
+31 30 2095000
mieke.roelofs@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Healthy pregnant, adults (> 18 years of age);
- Before/during the 35th week of pregnancy;
- Intending to breastfeed her infant;
- Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4243 |
NTR-old | NTR4388 |
Ander register | Nutricia Research : PLB.1.C/B |