Functional constipation is the most common type of constipation, and typically happens when babies or children hold back their bowel movements, either due to fear of pain and discomfort, or lack of awareness of their body telling them they need to go.
Constipation is a very common problem for children, approximately 1 in every 20 visits a child makes to a doctor is because of constipation.1 The Pediatric Functional Constipation Studies are researching a study drug for constipation in babies and children from 6 months to 5 years old.
Your child may be eligible to participate if they:
- Are 6 months to less than 2 years old (inclusive) OR 2 to 5 years of age (inclusive)
- Experience constipation
- Infrequent bowel movements
- Hard stool
- Painful defecation
- Abdominal pain
See if Your Child Is Eligible
What happens when I complete the questionnaire? If you think you might like your child to join the Pediatric Functional Constipation Studies or would like more information, please enter your information below so we can see if your child may be eligible and can contact you about the study.
If your child is eligible for the study, you will be matched to a study center in your area that is seeking pediatric participants who experience constipation or notify you when one becomes available. The study team will then contact you to explain more about the study, and to discuss next steps if your child continues to be eligible before you make your decision about participating.
About Functional Constipation
Functional constipation is the most common type of constipation.1 Symptoms may include, infrequent and hard stools, usually accompanied by discomfort and abdominal pain.
Pediatric functional constipation accounts for up to 25% of visits to a pediatric gastroenterologist across the United States.1 Around 40% of constipated children referred to a pediatric gastroenterologist remain symptomatic after 5 years.2
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug, which is a drug that hasn’t yet been approved to treat a specific medical condition. These may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live healthier lives. Even over-the-counter medications, such as non-steroidal anti-inflammatory drugs (NSAIDs), you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of the Pediatric Functional Constipation Studies?
The Pediatric Functional Constipation Studies are evaluating an investigational medication for the treatment of functional constipation in pediatric participants between the ages of 6 months to 5 years old. These studies will enroll at least 100 children with functional constipation at 45 different study centers globally.
Will I receive compensation?
Participants may receive compensation for travel and meals upon completion of study visits. Please discuss this with the study team when they contact you.
Is there a cost to participate?
There is no cost to participate in the Pediatric Functional Constipation Studies. If your child qualifies, they will receive all study-related care from a team of trained medical professionals at no cost.
What else do I need to consider?
The research team will be able to explain more about what the Pediatric Functional Constipation Studies will involve, and it is up to you to decide if you want your child to take part. You will be provided with a consent form to review and sign after the study team has reviewed the information for the Pediatric Functional Constipation Studies with you. You will be provided with all of the information you will need to make an informed decision on behalf of your child. Participation in this study is voluntary. Whether or not you decide for your child to participate in this study, this will not affect your child’s current or future relationships with doctors. If you decide for your child to participate and they qualify, you are free to withdraw them at any time without affecting those relationships.
How far is the study center?
We match you to a study center within as close travel distance from your home as possible. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out at any time, and we will delete of your contact information.
About the Pediatric Functional
Constipation Studies
The Pediatric Functional Constipation Studies will enroll about 100 babies and children with functional constipation at 45 different study centers globally.
In these studies, researchers will be evaluating an investigational medication for the treatment of functional constipation (FC) in pediatric participants between the ages of 6 months to 5 years old. This study drug has been previously approved in adults.
Who can take part in the Pediatric Functional Constipation Studies?
Your baby or child may be eligible to participate if they:
- Are 6 months to less than 2 years old (inclusive) OR 2 to 5 years of age (inclusive)
- Experience constipation
- Infrequent bowel movements
- Hard stool
- Painful defecation
- Abdominal pain