The presence of Candida albicans in breastmilk during the breastfeeding period

• Register: ISRCTN
• Last refreshed on: 20 August 2018
• Main ID: ISRCTN88839993
• Date of registration: 30/11/2016
• Prospective Registration: No
• Primary sponsor: Stig & Ragna Gorthon Foundation
• Public title: The presence of Candida albicans in breastmilk during the breastfeeding period
• Scientific title: A case/control study of breastfeeding women with and without symptoms that are anecdotally related to thrush in the breast. Cases and controls will be compared for presence of Candida albicans in their breast milk, premature cessation of breastfeeding and confidence in their ability to breastfeed
• Date of first enrolment: 01/04/2015
• Target sample size: 75
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN88839993
• Study type: Observational
• Study design: Observational case-control study (Diagnostic)

Countries of recruitment

Sweden

Contacts

• Name: Kirsti Kaski

• Name: Linda J. Kvist

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria for cases:
1. Breastfeeding woman
2. Adult, = 18 years
3. Exclusive or non-exclusive breastfeeding
4. Good understanding of Swedish language in spoken and written form
5. One or several symptoms on the nipple and areola or in the breast: red, extenuated, tender, burning, sloughing skin on the nipple and areola, with or without deep, radiating, cutting pain sensations in the breast

Inclusion criteria for the controls:
1. Breastfeeding woman
2. Adult, = 18 years
3. Exclusive or non-exclusive breastfeeding
4. Good understanding of Swedish language in spoken and written form
5. None of the symptoms on the nipple and areola or in the breast: red, extenuated, tender, burning, sloughing skin on the areola, with or without deep, radiating, cutting pain sensations in the breast

Exclusion criteria: 1. Breastfeeding women with pain, skin symptoms or sores which can be attributed to breastfeeding technical difficulties such as short frenulum, mastitis or Raynaud's syndrome
2. Women with excema-like skin conditions and white spot


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Candidosis of the breast during breastfeeding
Infections and Infestations
Candidosis of the breast during breastfeeding

Intervention(s)

Participants in the case group are informed about the study when they contact the breastfeeding clinic by telephone for symptoms associated with "thrush" infection in the breasts.
Participants in the control group get information about the study and are recruited at local baby-well clinics while they have the routine health control.

One consult appointment occasion with a breastfeeding consultant is booked for the participants in the case group, inclusive usual consult appointment according the breastfeeding clinic routine.

Participants in the case group are recruited at the breastfeeding clinic after receiving more information and given a written consent. A questionnaire is used to collect information about age, parity, age of the breastfed baby, history of previous candida infections, Diabetes (gestational or type 1), type of delivery, antibiotic treatment during and after delivery, breastfeeding level (exclusive/non-exclusive), pain location and severity (NAS) and breastfeeding efficacy. Breastmilk from the most painful breast is collected for culture for Candida albicans.

Participants in the control group meet the researcher once at the baby-well clinic direct after a health control. They receive more information about the study and give their written consent. The same questionnaire as with the cases is used and breastmilk is collected for culture for Candida albicans.

Participants in the case group receive four weekly telephone contacts from a breastfeeding consult in the breastfeeding clinic. A questionnaire is used to collect information about pain severity (NAS), breastfeeding success, changes in symptoms and medicine therapy. After four weeks of telephone contacts they receive a mail questionnaire with same questions monthly in three months.
The controls receive a mail questionnaire monthly in four months with questions about breastfeeding success and if they have had symptom or pain associated with thrush in the breasts.

Primary Outcome(s)

Presence of Candida albicans in breastmilk is measured using cultivation with Sabourad Agar or CROME Agar Candida at baseline

Secondary Outcome(s)

1. Breastfeeding efficacy in the breastfeeding mothers is measured by a validated breastfeeding instrument Breastfeeding Self Efficacy Scale- Short Form (BSES-SF) at baseline
2. Level of breastfeeding is measured by a questionnaire one month after the first contact with the researcher

Secondary ID(s)

2014/600

Source(s) of Monetary Support

Stig & Ragna Gorthon Foundation, Lions Research Foundation , Mjölkdroppen Association

Secondary Sponsor(s)

Mjölkdroppen Association

Lions Research Foundation, Skåne

Ethics review

Status:
Approval date:
Contact:

Central Ethical Review Board, Lund, Sweden, 16/09/2014 ref: 2014/600

Results

• Results available: Yes
• Date Completed: 01/06/2017