Karolinska University Hospital
Solna, Sweden
Not recruiting
Study on Prednisolone Transfer into Breast Milk and Infant Plasma for Mothers with Rheumatoid Arthritis and Other Inflammatory Conditions
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on understanding how the medication prednisolone affects breastfeeding children when their mothers are taking it. Prednisolone is a medication used to reduce inflammation in various conditions such as rheumatoid arthritis, systemic lupus erythematosus (SLE), myositis, psoriatic arthritis, and inflammatory bowel disease. The study will involve breastfeeding women who are being treated with prednisolone and their children.
The purpose of the study is to measure the amount of prednisolone that passes into the breast milk and the blood of the breastfeeding child. This will help to understand how much of the medication the child is exposed to. The study will observe the concentration of prednisolone in the child's blood two hours after the mother has taken her dose and breastfed the child. Additionally, the study will look at the levels of prednisolone and another related substance, prednisone, in the mother's breast milk and blood one hour after taking the medication.
Throughout the study, the health and safety of both the mother and child will be closely monitored. The study will also measure the levels of a natural hormone called cortisol in the child's blood at the same time as the other measurements. This research aims to provide valuable information on the safety of using prednisolone during breastfeeding, which can help guide treatment decisions for mothers with inflammatory conditions.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- The study is for breastfeeding women who are taking a medication called prednisolone. This medication is used to reduce inflammation, which is swelling and irritation in the body.
- The women must be taking doses of prednisolone up to 50 mg per day for any health condition.
- Only women who are 18 years of age or older can participate in the study.
- The woman participating in the study and the father of the child must both sign a document called an informed consent form. This form shows that they understand the study and agree to take part in it.
Who cannot join the trial?
4 criteria
- Patients who are not women. This study is only for women.
- Patients who are not breastfeeding. The study focuses on breastfeeding women.
- Patients who do not have conditions like **Rheumatoid Arthritis**, **SLE** (which stands for Systemic Lupus Erythematosus), **myositis** (muscle inflammation), **psoriatic arthritis** (a type of arthritis that affects some people with psoriasis), or **inflammatory bowel disease** (a group of disorders that cause inflammation of the intestines).
- Patients who are not considered part of a vulnerable population. This means the study is looking for participants who might need special protection or care.
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Verified Responsive Region Vaesterbotten
Umea, Sweden
Trial locations
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Investigated drugs
Prednisolone is a medication used to reduce inflammation in various conditions. In this clinical trial, the focus is on understanding how much of this medication passes into the breast milk of lactating women and subsequently into the plasma of their breast-fed infants. This study aims to ensure the safety of breastfeeding while the mother is undergoing treatment with prednisolone.
What is already known about the treatment
Prednisolone – Prednisolone is typically administered orally in the form of tablets or liquid, and it can also be given as an injection. It is widely recognized in medical literature as a corticosteroid used to reduce inflammation and suppress the immune system. The main therapeutic indications for prednisolone include rheumatoid arthritis, systemic lupus erythematosus (SLE), myositis, psoriatic arthritis, and inflammatory bowel disease. At the molecular level, prednisolone works by mimicking the effects of hormones produced by the adrenal glands, thereby reducing inflammation and altering the immune response. It is classified pharmacologically as a glucocorticoid.
Investigated diseases
Rheumatoid Arthritis
A chronic inflammatory disorder affecting the joints, causing pain, swelling, and stiffness. It often begins in smaller joints and can progress to larger ones. Over time, it may lead to joint deformity and loss of function. The inflammation can also affect other body systems, such as the skin, eyes, and lungs.
Systemic Lupus Erythematosus (SLE)
An autoimmune disease where the immune system attacks its own tissues, causing widespread inflammation. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms vary widely and can include fatigue, joint pain, and skin rashes. The disease often has periods of flares and remissions.
Myositis
A group of conditions characterized by inflammation of the muscles, leading to muscle weakness. It can affect muscles throughout the body, making everyday activities difficult. Some forms of myositis can also involve skin rashes or affect other organs. The progression can vary, with some experiencing rapid onset and others a more gradual development.
Psoriatic Arthritis
An inflammatory arthritis associated with psoriasis, a skin condition. It causes joint pain, stiffness, and swelling, often affecting fingers and toes. The disease can also cause changes in the nails and lead to fatigue. It may progress to affect larger joints and the spine.
Inflammatory Bowel Disease
A term primarily referring to two conditions, Crohn's disease and ulcerative colitis, characterized by chronic inflammation of the gastrointestinal tract. Symptoms include abdominal pain, diarrhea, and weight loss. The inflammation can lead to complications such as strictures or fistulas. The disease often has periods of active symptoms and remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508913-18-00Estimated enrolment30 patientsSponsorUppsala Universitet
sourced from the EU Clinical Trials Register and site verification
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