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Study on Linaclotide for Treating Functional Constipation in Children Aged 6 Months to Less Than 2 Years

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Functional Constipation in young children aged 6 months to less than 2 years. Functional Constipation is a condition where children have difficulty passing stools, which can lead to discomfort and other symptoms. The study will use a medication called Linaclotide, which is taken orally in the form of a capsule. Linaclotide works as an agonist of guanylate cyclase C (GCC), which means it helps to increase fluid in the intestines and speed up the movement of stools through the gut.

The purpose of the study is to find a safe and effective dose of Linaclotide for treating Functional Constipation in this age group. The study will be conducted over a period of 4 weeks. During this time, participants will receive either Linaclotide or a placebo. The study will monitor changes in the frequency and consistency of bowel movements, as well as any straining during bowel movements, to assess the effectiveness of the treatment.

Participants will be closely observed to ensure their safety and to determine the best dose of Linaclotide that provides relief from constipation symptoms. The study aims to improve the quality of life for young children suffering from Functional Constipation by identifying a treatment that is both safe and effective.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    The legally authorized representative (LAR), parent, or guardian must sign an informed consent form before any study-specific procedures begin.

    The child must be between 6 months and less than 2 years old at the time of consent.

    The child must meet specific criteria for functional constipation, such as having fewer than two bowel movements per week.

  2. Step 2

    Randomization

    The child will be randomly assigned to receive either linaclotide or a placebo.

    Linaclotide is administered orally in the form of a hard capsule.

  3. Step 3

    Study intervention period

    The child will receive the assigned treatment for a period of 4 weeks.

    The main goal is to find a safe and effective dose of linaclotide for children with functional constipation.

  4. Step 4

    Monitoring and assessment

    Throughout the 4-week period, changes in bowel movement frequency, stool consistency, and straining will be monitored.

    These changes will be reported by the LAR, parent, or guardian.

  5. Step 5

    Completion

    At the end of the 4-week period, the study will evaluate the safety and effectiveness of the treatment.

    The results will help determine the best dose of linaclotide for young children with functional constipation.

Who can join the trial?

5 criteria

  • The child's parent or guardian must willingly sign and date a consent form that has been approved by an independent ethics committee or review board before any study-related activities begin.
  • The child must be between 6 months and less than 2 years old at the time the consent form is signed.
  • The child must have a weight to height ratio that is at or above the 2nd percentile for their age when the consent form is signed. This means the child's growth is within a healthy range for their age.
  • The child must meet certain criteria for Functional Constipation (FC) for at least 1 month before the first study visit. This includes having 2 or fewer bowel movements per week without using laxatives, a history of holding in stool, painful or hard bowel movements, large stools, or a large amount of stool in the rectum. Other symptoms may include irritability, reduced appetite, or feeling full quickly.
  • Based on a diary kept by the parent or guardian, the child must have fewer than 2 small bowel movements per week during the 14 days before joining the study. A small bowel movement is one that happens without using laxatives, enemas, or suppositories on the day of or the day before the bowel movement.

Who cannot join the trial?

7 criteria

  • Children who are not between 6 months and less than 2 years old cannot participate.
  • Children who do not have Functional Constipation (FC) cannot participate. Functional Constipation is a condition where a child has difficulty passing stools regularly, but there is no physical or medical reason for it.
  • Children with any other medical conditions that might interfere with the study cannot participate.
  • Children who are taking medications that might affect the study results cannot participate.
  • Children who have participated in another clinical trial recently cannot participate.
  • Children who have any allergies or reactions to the study medication cannot participate.
  • Children whose parents or guardians do not agree to follow the study procedures cannot participate.
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Investigated drugs

Linaclotide is a medication being studied for its ability to help young children with functional constipation. The trial aims to find a safe and effective dose for children aged 6 months to less than 2 years. Linaclotide works by increasing the amount of fluid in the intestines, which can help make bowel movements easier and more regular. The study will evaluate how well this medication works and how safe it is for young children over a period of 4 weeks.

What is already known about the treatment

Linaclotide – Linaclotide is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating functional constipation in young children. It is primarily used to relieve symptoms of constipation by increasing the secretion of fluid in the intestines, which helps to ease bowel movements. Linaclotide works by activating a specific receptor on the surface of intestinal cells, leading to increased levels of cyclic guanosine monophosphate (cGMP), which in turn stimulates fluid secretion and accelerates intestinal transit. It is classified as a guanylate cyclase-C agonist.

Investigated diseases

Functional Constipation – Functional constipation is a common condition characterized by infrequent bowel movements or difficulty passing stools. It often occurs without any underlying medical cause and can lead to discomfort and bloating. In children, it may result in hard, dry stools and can cause pain during bowel movements. The condition can vary in severity, with some individuals experiencing mild symptoms and others facing more significant challenges. It is often diagnosed based on symptoms and a physical examination. Management typically focuses on dietary changes and lifestyle adjustments to improve bowel habits.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2022-501947-34-00Protocol codeM21-862Estimated enrolment29 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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