The presence of Candida albicans in breastmilk during the breastfeeding period
| ISRCTN | ISRCTN88839993 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88839993 |
| Secondary identifying numbers | 2014/600 |
- Submission date
- 14/11/2016
- Registration date
- 30/11/2016
- Last edited
- 09/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Breast pain during the breastfeeding period can affect mothers’ self-confidence and her motivation to continue breastfeeding. Earlier research has not given any clear answers as to whether Candida Albicans, otherwise known as “thrush”, can be the cause of breast pain. Different studies have shown varying results regarding the presence of Candida Albicans in breast milk. The aim of the present study is to examine whether women with symptoms that sound like they are related to thrush in the breast (cases) more often have Candida Albicans in their breast milk than women without these symptoms (controls). The study will examine whether women with breast pain more often cease breastfeeding than women without symptoms and whether the two groups show any difference in their confidence to breastfeed.
Who can participate?
Adult breastfeeding women over 18 years of age with and without breast pain.
What does the study involve?
All participants have samples of breast milk collected at the start of the study, which is then tested for the presence of the yeast Candida Albicans. Participants are also asked to complete a questionnaire to measure their self-confidence in breast feeding. One month later, participants are interviewed in order to find out whether they have continued breastfeeding.
What are the possible benefits and risks of participating?
There are no benefits or risks to individual women who choose to participate.
Where is the study run from?
Helsingborg Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2014 to June 2017
Who is funding the study?
1. Stig & Ragnar Gorthon Foundation (Sweden)
2. The Milk Drop Foundation (Sweden)
3. Lions Research Foundation (Sweden)
Who is the main contact?
1. Miss Kirsti Kaski (public)
kirsti.kaski@skane.se
2. Mrs Linda J. Kvist (scientific)
linda.kvist@med.lu.se
Contact information
Public
BB-avdelning
Helsingborg Hospital
Charlotte Yhlens gata 10
Helsingborg
25187
Sweden
| Phone | +46 (0)70 827 8604 |
|---|---|
| kirsti.kaski@skane.se |
Scientific
Lund University
Medicinska fakultetet
Baravägen 3
Lund
22100
Sweden
 ORCID ID |
0000-0001-5073-2419 |
|---|---|
| Phone | +46 (0)42 227 113 |
| linda.kvist@med.lu.se |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Community |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN88839993_PIS_11Nov2014_ControlGroup_Swedish.docx |
| 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 |
| Study objectives | Candida albicans is present in the milk of breastfeeding women who report breast pain to a higher degree than women without breast pain |
| Ethics approval(s) | Central Ethical Review Board, Lund, Sweden, 16/09/2014 ref: 2014/600 |
| Health condition(s) or problem(s) studied | Candidosis of the breast during breastfeeding |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Presence of Candida albicans in breastmilk is measured using cultivation with Sabourad Agar or CROME Agar Candida at baseline |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2014 |
| Completion date | 01/06/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 35 participants in each study group. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 01/03/2017 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Hlsingborg
25187
Sweden
Sponsor information
Other
Stortorget 16
Box 1417
Helsingborg
25223
Sweden
| Phone | +46 (0)42 18 33 57 |
|---|---|
| info@gorthonstiftelsen.se | |
| Website | http://www.gorthonstiftelsen.se/ |
Charity
Gottåkravägen 45
Höllviken
236 41
Sweden
| Phone | +46 (0)4045 78 52 |
|---|---|
| info@lffs.se | |
| Website | http://www.lffs.se |
Charity
Södra Vallgatan 5
Helsingborg
25187
Sweden
Not defined
| Website | https://www.gorthonstiftelsen.se/ |
|---|---|
"ROR" |
https://ror.org/0192sgm30 |
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data is expected to be available after the analysis of the data has been finished. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 11/11/2014 | 30/11/2016 | No | Yes | |
| Participant information sheet | 11/11/2014 | 30/11/2016 | No | Yes | |
| Results article | results | 07/06/2018 | Yes | No |
Additional files
- ISRCTN88839993_PIS_11Nov2014_ControlGroup_Swedish.docx
- Uploaded 30/11/2016
- ISRCTN88839993_PIS_11Nov2014_InterventionGroup_Swedish.docx
- Uploaded 30/11/2016
Editorial Notes
09/07/2018: Publication reference added.
