Study on Linaclotide for Treating Functional Constipation in Children Aged 2 to 5 Years

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What is this study about?

This clinical trial is focused on studying Functional Constipation in young children aged 2 to 5 years. The study will evaluate the effects of a medication called Linaclotide, which is taken in capsule form. Linaclotide works as an agonist of guanylate cyclase C (GC-C), which means it helps to stimulate certain processes in the body that can improve bowel movements. The trial will compare the effects of Linaclotide with a placebo to understand its safety and effectiveness in treating Functional Constipation in children.

The purpose of the study is to assess how well Linaclotide works over a 12-week period and to ensure it is safe for long-term use. The study is divided into two parts. In the first part, children will receive either Linaclotide or a placebo for 12 weeks. During this time, caregivers will observe changes in the frequency of bowel movements, stool consistency, and any straining during bowel movements. In the second part, children who have completed the first part will continue to receive Linaclotide to further evaluate its long-term safety.

This trial aims to provide valuable information on the treatment of Functional Constipation in young children, potentially offering a new option for managing this condition. The study will help determine if Linaclotide can be a safe and effective treatment for improving bowel habits in children with Functional Constipation.

1 joining the study

Upon joining the study, the caregiver or parent provides consent for participation. The child must be between 2 to 5 years and 11 months old.

The child should not have any significant health issues that could interfere with the study, as determined by a medical examination.

2 screening visit

During the screening visit, the child’s health is assessed through physical examination, vital signs, and laboratory tests.

The child must meet specific criteria for functional constipation, such as having 2 or fewer bowel movements per week for at least one month before the screening.

3 preintervention visit

Before starting the study medication, any laxatives the child is using must be discontinued in favor of the study’s rescue medicine.

The caregiver will use an electronic diary to record the child’s bowel movements for 14 days before the randomization day.

4 randomization and start of treatment

The child is randomly assigned to receive either linaclotide or a placebo in the form of a capsule taken orally.

The treatment lasts for 12 weeks, during which the caregiver observes and records the child’s bowel movement frequency, stool consistency, and any straining or fecal incontinence.

5 open-label treatment extension

After the initial 12-week period, there is a 24-week open-label treatment extension where all participants receive linaclotide.

The focus is on assessing the long-term safety of the medication.

6 end of study

At the end of the study, the child’s health is evaluated to ensure there are no adverse effects from the medication.

The study aims to understand the change in bowel movement frequency and other related symptoms from the start to the end of the treatment.

Who Can Join the Study?

The child must be between 2 years and 5 years and 11 months old when the caregiver or parent gives signed consent.
The child should not have any health conditions or important findings during a physical exam, vital sign check, heart test (ECG), or lab tests that could be a safety concern or interfere with the study.
The child must meet the modified Rome IV criteria for functional constipation. This means that for at least 1 month before the first visit, the child has had 2 or fewer bowel movements per week without using laxatives, suppositories, or enemas in the 24 hours before each bowel movement.
The caregiver or parent must agree to stop using any laxatives before the second visit and use only the study-approved medicine if needed.
Based on a daily diary, the child should have an average of 2 or fewer spontaneous bowel movements (SBMs) per week during the 14 days before the randomization day. An SBM is a bowel movement that happens without using laxatives, enemas, or suppositories on the day of or the day before the bowel movement.

Who Cannot Join the Study?

Children who do not have Functional Constipation cannot participate. Functional Constipation is a type of constipation without a known medical cause.
Children who do not meet the modified Rome IV criteria for childhood constipation cannot participate. The Rome IV criteria are guidelines used by doctors to diagnose constipation.
Children who are not between the ages of 2 to 5 years cannot participate.
Children who have not completed the study intervention in Part 1 or have not completed Study LIN-MD-67 cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Amphia Hospital	Breda	The Netherlands
Tokuda Hospital	Sofia	Bulgaria
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev	Sofia	Bulgaria
University Multiprofessional Hospital For Active Treatment Kanev AD	Ruse	Bulgaria
Medcenter Nova Clinic Ltd.	Varna	Bulgaria
Aolumoyhq Umu	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	31.08.2023
The Netherlands	Not recruiting	31.08.2023

Trial locations

Investigated drugs:

Linaclotide

Linaclotide is a medication used in this clinical trial to help children aged 2 to 5 years who have functional constipation. Functional constipation is a condition where children have difficulty passing stools, which can be uncomfortable and distressing. Linaclotide works by increasing the amount of fluid in the intestines, which helps to soften stools and make them easier to pass. This medication is being tested to see if it is safe and effective for young children with this condition over a period of 12 weeks. Additionally, the trial aims to understand the long-term safety of using linaclotide in children who have already participated in the initial part of the study or a related study.

Investigated diseases:

Constipation

Functional Constipation – Functional Constipation is a common condition characterized by infrequent bowel movements or difficult passage of stools. It often involves hard or lumpy stools, straining during bowel movements, and a sensation of incomplete evacuation. The condition progresses with varying frequency and severity of symptoms, which can include abdominal discomfort and bloating. In children, it may also lead to episodes of fecal incontinence, especially if toileting skills are not fully developed. The progression of symptoms can be influenced by dietary habits, physical activity, and stress levels. Over time, if not managed, it can lead to more persistent discomfort and potential complications such as hemorrhoids.

Trial ID:

2022-501946-31-00

Protocol code:

M21-572

NCT ID:

NCT05652205

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Linaclotide for Treating Functional Constipation in Children Aged 2 to 5 Years

What is this study about?

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