Effect of the probiotic Lactobacillus reuteri on breast inflammation and lactational mastitis

Completed

Conditions: Breast inflammation/lactational mastitis
Pregnancy and Childbirth

Registration Number: ISRCTN98567612

Lead Sponsor: Sahlgrenska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 52

Inclusion Criteria

1. Women seeking help for breast inflammation and mastitis symptoms and who are counseled to home care without antibiotic treatment by health care professionals at the Department of obstetrics at Sahlgrenska University hospital. According to the hospital’s routine women are recommended home care without antibiotic treatment if other not-breast-related diagnosis have been excluded, if the woman’s general condition is stable and symptoms started no longer than 2-3 days before. Women with longer time since symptom debut will be offered a visit to the hospital. If the care giver after taking anamneses and examination decides that both general condition and local status allow home care without antibiotic treatment, the woman is still eligible for the study.
2. Breast inflammation/Mastitis symptoms defined as fever start = 38°C before 4 hours or longer and at least 1 point for erythema and 1 point for breast tension on the Kvist-scale” according to the research midwife’s evaluation
3. Age =18 years
4. Capable of giving informed consent
5. Willing to comply with treatment application
6. Capable of understanding and complying with study protocol requirements
7. That the baby is considered healthy according to the routine check ups
8. Exclusive breastfeeding

Exclusion Criteria

1. Judged by a health care professional to be in need of antibiotic treatment for her breast symptoms as described above
2. Current breast injury, trauma, abscesses or other mammary pathology
3. History of/current breast cancer
4. Breast surgery in the past month
5. New pregnancy
6. Premature baby, born <37 weeks of gestational age
7. Autoimmune disease (both mother and child)
8. Known or suspected allergies to any of the components of the study product (both mother and child)
9. Participation in another investigational drug study within 30 days prior to treatment start
10. Use of any other probiotic (oral or local)
11. Ongoing antibiotic treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of flu-like symptoms as experienced by study participants according to the symptoms diary, fever in °C as measured by the research midwife and local inflammation measured as scoring 0 on the Kvist scale for redness, pain and tension of the breast as well as fissures in the nipple symptoms from day 1 to 14

Secondary Outcome Measures

Name	Time	Method
1. Inflammatory markers: concentration of C-reactive protein (CRP) and IL6 (blood and breast milk); TNFa (blood) measured day 1 and day 14<br>2. Infectious agents (pathogenic bacterial species count in breast milk) and identification and count of Lactobacillus reuteri in breast milk samples measured day 1 and day 14<br>3. Number of mothers choosing to continue breastfeeding after they have undergone an episode of breast inflammation or lactational mastitis as reported by study participants during the telephone interview on day 28<br>4. Symptoms in the breastfed children: agitation, sleep patterns, gastrointestinal symptoms and thrush in the mouth (which could be a complication due to maternal antibiotic treatment) as registered in the symptoms diary day 1 o 14<br>5. Number of women needing antibiotics treatment until day 28