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 study about?

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.

1 joining the study

Participation begins after signing an informed consent form. This form must be signed by the breastfeeding woman and the father of the child.

Eligibility requires the woman to be 18 years or older and currently breastfeeding while being treated with prednisolone.

2 medication administration

The breastfeeding woman will take prednisolone orally, with doses up to 50 mg per day. This medication is used to reduce inflammation in conditions such as rheumatoid arthritis, lupus, myositis, psoriatic arthritis, and inflammatory bowel disease.

3 sample collection

One hour after taking the prednisolone dose, samples of breast milk and maternal plasma will be collected to measure the concentration of prednisolone and prednisone.

Two hours after the infant is breastfed, a blood sample will be taken from the child to measure the concentration of prednisolone in the plasma.

4 additional measurements

At the same time as the infant’s blood sample is taken, the concentration of cortisol in the infant’s blood will also be measured.

5 end of participation

The study is expected to conclude by December 31, 2025. Participation will continue until the necessary data is collected.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Karolinska University Hospital	Solna	Sweden
Region Vaesterbotten	Umea	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

Betamethasone Sodium Phosphate

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.

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 ID:

2023-508913-18-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Prednisolone Transfer into Breast Milk and Infant Plasma for Mothers with Rheumatoid Arthritis and Other Inflammatory Conditions

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?