The study will last 1 month during a Summer Camp. Your child will have tests and evaluations to monitor his/her health during that month. Following this period, you will be contacted 1 month after study completion for final evaluation (see dates in the study overview).
How long will the study last?
Why is it necessary to perform this study on a Summer Camp?
Carrying a gluten-free diet requires some sacrifice including removing any gluten-containing ingredients at home, learning how to use alternative gluten-free ingredients and ensuring 100% compliance to this diet for the whole family for a period of at least 1 month. Therefore, we have created an exciting Summer Camp that provides all the meals to the kids but also creates a fun and educational environment to meet other kids. A win-win situation! Furthermore, we will be able to carry in-depth individualized investigation of potential causes of the kidney disease in your child and their response to treatment with the involvement of leader researchers in the field. Lastly, healthcare professionals will be monitoring and providing a well-balanced diet with all the nutrients required for the health of your child.
For many children with kidney disease, attending a camp can be the first step toward gaining confidence for the future and understanding they are not alone. The camp will help children develop skills for living with the disease in the best way – through activity, support and fun.
What are the potential risks and benefits?
The study doctor will explain all of the potential risks and benefits of participating in the study. Overall, there are no risks with a gluten-free and diary-free diet as long as other foods provide the nutrients required on a daily basis, including calcium on the diet. For this reason, we will have nutritionist carefully designing the meals during this Summer Camp, ensuring a well-balanced diet. The risks from drawing blood include bruising and pain at the insertion site. Only persons trained in phlebotomy will draw blood.
How many research samples are going to be taken during the Study?
Blood samples will be collected at three points during the Camp (day 0, day 14 and day 29) and 1 month after finishing the Camp.
Urine and stool samples will be collected weekly during the Camp and 1 month after that.
Does it cost anything to participate?
The Summer Camp experience including housing, food, study-related tests and activities will be provided at no cost. Lectures and educational materials will also be provided for parents in order for them to better understand all the food ingredients and preparation strategies to ensure a compliance with a gluten-free diet, which is critical in influencing any potential response to the diet change. Parents will only be responsible for the travel expenses to get to Orlando, Florida.
Does this study require my child to stop taking other medications?
Why is this study exciting compared to other treatment strategies for patients with steroid-resistant nephrotic syndrome?
It is clear that diet may influence our health. In nephrotic syndrome, few patients have reported success in controlling the amount of protein in the urine with dietary gluten and dairy restrictions. However, it is unclear why some patients may respond and what is the exact reason for this response. Since dietary changes such as the one proposed are much less toxic than immunosuppressive drugs, this study may allow us to identify patients who may respond to this dietary intervention under close medical monitoring by health care providers and accompanied by research investigation to better understand the disease on individual patients.