APProve: CAn Probiotics ImPROVE Breastfeeding Outcomes?

Phase 4

Completed

• Conditions: Mastitis; Reproductive Health and Childbirth - Breast feeding; Inflammatory and Immune System - Normal development and function of the immune system; Infection - Other infectious diseases

• Registration Number: ACTRN12615000923561
• Lead Sponsor: Perinatal Research Group, Kolling Institute, University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Pregnant women at least 18 years of age at 37 weeks gestation or later with a singleton pregnancy will be invited to participate in the trial. They will currently not be taking commercial probiotics containing lactobacillus fermentum; and will own a smartphone. Their intention at the time of consent will be to breastfeed their baby.

Exclusion Criteria

Women with a history of Raynaud syndrome will not be eligible to participate in the trial. Any delivery/breast complication rendering the infant unable to breastfeed will be excluded. Women unable to speak/understand English will not be consented.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be incidence of mastitis up to 8 weeks following delivery as measured by: <br>1.Clinical diagnosis of mastitis<br>OR<br>2.At least two of the following breast symptoms:<br> *Pain<br> *Redness / inflammation<br> *Lump / swelling<br>AND at least one of the following systemic symptoms:<br> *flu-like symptoms (body aches, headaches and chills) <br> *fever greater or equal to 38 degrees C<br>(Above symptoms must present for at least 24 hours - i.e. recorded for 2 or more consecutive days on the mobile phone application system or calendar diary.)<br>[Within 8 weeks following delivery.]