We are inviting you to take part in a research study for babies and children who suffer from constipation and infrequent bowel movements.
The research study will be conducted at various centers globally. You and your child will be matched to a study center within a close distance to your home.
The Functional Constipation Study is being done to assess how well an investigational study drug works to improve the symptoms of constipation in babies and children.
Your child may qualify for the Functional Constipation Study if they:
What happens if I sign up? We will match you to a study center in your area that need babies and children who experience constipation, or we will notify you when one becomes available. The study staff will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to participate in the Functional Constipation Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the research study. Keep in mind that participation is entirely voluntary. If you do decide to take part in a research study, you may change your mind about participating at any time.
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.1
Constipation can cause infrequent and hard stools, usually accompanied by discomfort and abdominal pain. In some cases, manual disimpaction (removal of the rectal fecal mass) is required, followed by a course of other long-term medication.1
Pediatric functional constipation accounts for up to 25% of visits to a pediatric gastroenterologist across the United States.1 About 40% of children who suffer from constipation are referred to a pediatric gastroenterologist and remain symptomatic after 5 years. These symptoms may persist into adulthood.2
The Functional Constipation Study are evaluating an investigational medication for the treatment of functional constipation in pediatric participants between the ages of 6 months to 5 years old.
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug or device – these may include how well an investigational study drug, or device, works for a certain condition. All medications and devices must be tested in clinical research studies before they can be approved and prescribed to patients.
A research study is the process by which new and innovative medications, treatments and devices are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications, such as 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.
The Pediatric Functional Constipation Study is a multi-center study researching the effectiveness of an investigational treatment for babies and children who experience functional constipation.
There is no cost to participate in the Pediatric Functional Constipation Study. If you decide to take part:
The study team will be able to explain more about what the Pediatric Functional Constipation Study will involve, and it is up to you to decide if you want your child to take part. Participation in this study is voluntary. Whether or not you decide to participate in the study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
We match you to a research center within a close travel distance from your home. 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 research center in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your details.
The Functional Constipation Study will enroll babies and children who experience constipation at various study centers globally. The research study will include visits to a study center within a close distance to your home.
Participants will be provided with all study drugs, examinations and medical care related to the research study at no cost to you. Additionally, patients will be compensated for their time and travel.
The Functional Constipation Study is being done to assess how well an investigational study drug works to treat babies and children who experience constipation or infrequent bowel movements.
Your child may qualify for the Functional Constipation Study if they: