Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
This study is investigating a medication called eluxadoline for children and teenagers aged 6 to 17 who experience Irritable Bowel Syndrome (IBS) with diarrhoea. The main goals are to find out how effective eluxadoline is at reducing IBS symptoms, how the body processes the medication in young people, and to check if it's safe and well-tolerated. Currently, only children aged 6 to 11 are being enrolled, as recruitment for the 12 to 17 age group has finished. Participants will either receive the study medicine or a placebo (a dummy drug with no active ingredients) to help researchers understand its effects. This is a Phase 2 study, meaning it's an early look at the medicine's potential benefits and side effects in a larger group of people.
At a glance
What is this study about?
This study is looking into a new use for a medicine called eluxadoline. It's for children and teenagers between 6 and 17 years old who have a common gut problem called Irritable Bowel Syndrome (IBS), specifically the type that causes diarrhoea (often called IBS-D). IBS can cause tummy pain and changes in bowel habits, which can be really difficult to live with.
The main aim of the research is to see if eluxadoline can help ease these IBS-D symptoms in young people. Researchers also want to understand how the medicine travels through a child's body – how it's absorbed, used, and cleared out. This is important because children's bodies can react differently to medicines than adults' bodies. Finally, they will be checking very carefully for any side effects and how well children tolerate the medicine.
This is an important step because finding effective and safe treatments for children with IBS-D can significantly improve their quality of life. By comparing the medicine to a placebo (a dummy treatment), researchers can get a clear picture of whether eluxadoline is genuinely helping. While the study has finished recruiting teenagers aged 12-17, they are still looking for children aged 6-11 to take part.
Key takeaways
- The study investigates eluxadoline for children and teenagers with IBS-D.
- It aims to check effectiveness, safety, and how the medicine works in young bodies.
- Participants will receive either eluxadoline or a placebo.
- Currently recruiting children aged 6-11 years old.
- Regular checks and an electronic diary will be part of taking part.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, children must be between 6 and 17 years old. For younger children aged 6 to 11, their parent or guardian will need to give written permission, and the child will also need to agree to take part. For older children, they will provide their own agreement, with parental permission.
Participants must have been diagnosed with IBS-D according to specific guidelines. This means they should have experienced tummy pain for at least four days a month over two months, along with changes in their bowel habits – either how often they go to the toilet or the appearance of their stools. Importantly, doctors must have ruled out other medical conditions that could be causing these symptoms.
Girls and young women who could become pregnant must not be pregnant or breastfeeding, and they must agree to use effective contraception during the study and for about 30 days after their last dose of medicine. They will also have pregnancy tests to ensure they are not pregnant before starting the study medicine.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child aged between 6 and 11 years old?
- Has a doctor diagnosed your child with Irritable Bowel Syndrome with diarrhoea (IBS-D)?
- Does your child experience tummy pain at least 4 days a month for over 2 months, along with changes in their pooing habits?
- If your child is a girl, are they not pregnant or breastfeeding, and would they be able to use contraception during the study?
- Are you, as a parent or guardian, able to provide permission and understand what the study involves?
What does participation involve?
If you or your child take part in this study, the process will involve a few steps. First, there will be screening appointments to check if your child meets all the criteria. If they do, they will then be randomly assigned to either receive the study medicine (eluxadoline) or a placebo (a dummy medicine that looks the same but has no active ingredients). This is to ensure fair comparison.
Throughout the study, your child will take the assigned medicine regularly. You'll likely need to come to regular clinic visits for check-ups, assessments, and to monitor for any side effects. Your child will also be asked to complete an electronic diary (eDiary) to record their symptoms and experiences. If your child is 6-11 years old and finds it hard to use the eDiary, a trained adult can help them fill it in. The total length of the study from start to finish would be discussed when you inquire.
Potential risks and benefits
Locations (46)
- HealthStar Research of Hot Springs PLLC /ID# 234609Verified postcodeHot Springs, United States· Recruiting
- Applied Research Center of Arkansas /ID# 238070Verified postcodeLittle Rock, United States· Recruiting
- Kindred Medical Institute, LLC /ID# 237368Verified postcodeCorona, United States· Completed
- Duplicate_VVCRD Research /ID# 234606Verified postcodeGarden Grove, United States· Completed
- Duplicate_Center for Clinical Trials LLC /ID# 234630Verified postcodeParamount, United States· Completed
- Sunrise Research Institute /ID# 237382Verified postcodeMiami, United States· Completed
- South Miami Medical & Research Group Inc. /ID# 234655Verified postcodeMiami, United States· Recruiting
- Valencia Medical & Research Center /ID# 234672Verified postcodeMiami, United States· Recruiting
- Florida Research Center, Inc. /ID# 236514Verified postcodeMiami, United States· Recruiting
- Duplicate_Wellness Clinical Research /ID# 237401Verified postcodeMiami Lakes, United States· Completed
- Global Research Associates /ID# 234646Verified postcodeAtlanta, United States· Recruiting
- Children's Ctr Digestive, US /ID# 237575Verified postcodeAtlanta, United States· Completed
Common questions
What is IBS-D?
IBS-D stands for Irritable Bowel Syndrome with Diarrhoea. It's a common condition that causes tummy pain and frequent loose stools.
What is eluxadoline?
Eluxadoline is a medicine generally used for adults with IBS-D to help manage their symptoms.
What does 'placebo' mean?
A placebo is a 'dummy' pill or treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers see if the real medicine is truly effective.
Can my child definitely get the medicine?
No, participants will be randomly assigned to either receive the study medicine or the placebo. This is standard practice in clinical trials to ensure fair testing.
Who can currently join the study?
Right now, the study is continuing to enrol children aged 6 to 11 years old with IBS-D. The 12-17 age group is no longer being recruited.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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