What side effects are associated with this type of intervention?

Treatments for constipation that increase intestinal fluid secretion and accelerate transit time, such as linaclotide, commonly cause side effects like diarrhea, abdominal pain, and flatulence. Other similar medications, like lubiprostone and plecanatide, also frequently result in nausea, diarrhea, and abdominal discomfort. These side effects are usually mild to moderate and tend to lessen as the body adapts to the treatment.

What prior FDA approvals exist?

Linaclotide, approved by the FDA for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation, works by increasing intestinal fluid secretion and accelerating transit time. Another similar drug is plecanatide, which also increases intestinal fluid secretion to help with bowel movements. Both drugs are guanylate cyclase-C agonists, which help to alleviate constipation by enhancing fluid secretion in the intestines.

What other types of research exist?

Promising novel alternatives to Linaclotide for constipation treatment in 2024 include: 1) Plecanatide, which works similarly to Linaclotide by activating guanylate cyclase-C receptors to increase intestinal fluid secretion and accelerate transit. 2) Prucalopride, a selective serotonin 5-HT4 receptor agonist that enhances colonic motility. 3) Tenapanor, which inhibits the sodium/hydrogen exchanger 3 (NHE3) in the gut, reducing sodium absorption and increasing water secretion into the intestines. These alternatives offer different mechanisms of action and have shown efficacy in clinical trials.

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Guanylate Cyclase-C Agonist

Linaclotide for Pediatric Constipation

Phase 2

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals must be 6 months to less than 1 year and 11 months old, at the time the legally authorized representative (LAR)/parent/guardian signs the informed consent in alignment with local requirements.

History of large-diameter stools

Must not have

Participant has conditions that could interfere with drug absorption, including, but not limited to, short bowel syndrome.

Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 5

Summary

This trial tests linaclotide, a medication that may help young children with constipation by making their stools softer and easier to pass. The study involves children aged 6 months to less than 2 years who struggle with constipation.

Who is the study for?

This trial is for children aged 6 months to less than 2 years with functional constipation. They must meet certain criteria like having a history of hard bowel movements or infrequent defecation, and their parents must be able to use an eDiary for tracking. Children with conditions like celiac disease, cystic fibrosis, untreated hypothyroidism, chromosomal disorders, or any condition affecting drug absorption cannot participate.

What is being tested?

The study tests Linaclotide against a placebo in treating pediatric functional constipation. Initially, different dosages are given consecutively in three groups; later participants are randomly assigned to either the drug or placebo. The treatment involves daily oral solution intake over four weeks at various global sites.

What are the potential side effects?

Possible side effects of Linaclotide may include diarrhea, abdominal pain, gas, bloating and possibly allergic reactions. Since this is a pediatric trial involving very young children, close monitoring for any adverse effects will be essential.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 6 months and less than 2 years old.

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I have a history of large stools.

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I have a large stool blockage in my rectum.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like short bowel syndrome that could affect drug absorption.

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I have celiac disease or it's suspected but not confirmed by a biopsy.

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I have cystic fibrosis.

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I have Down's syndrome or another chromosomal disorder.

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I have a birth defect affecting my anus.

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I have a disorder affecting the nerves or muscles of my intestines.

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I have a condition affecting my nerves, like spinal issues or neurofibromatosis.

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I have inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in overall Spontaneous Bowel Movement (SBM) frequency rate (SBMs/week) during the Study Intervention Period

Change from baseline in stool consistency (Bristol Stool Form Scale) during the Study Intervention Period

Change from baseline in straining during the Study Intervention Period

+1 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2, PlaceboExperimental Treatment1 Intervention

Participants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks.

Group II: Part 2, LinaclotideExperimental Treatment1 Intervention

Participants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks.

Group III: Part 1, Linaclotide Dose CExperimental Treatment1 Intervention

Linaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks

Group IV: Part 1, Linaclotide Dose BExperimental Treatment1 Intervention

Linaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks

Group V: Part 1, Linaclotide Dose AExperimental Treatment1 Intervention

Linaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Linaclotide

2008

Completed Phase 4

~9640

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Linaclotide, a treatment for constipation, increases intestinal fluid secretion and accelerates transit time, which helps soften stools and promote bowel movements. This mechanism is crucial for constipation patients as it directly alleviates the primary issues of hard stools and slow transit, thereby improving bowel function and providing symptom relief. Other common treatments for constipation include fiber supplements, which add bulk to stools, and osmotic laxatives, which draw water into the intestines to ease stool passage. These treatments collectively aim to enhance stool consistency and bowel regularity.

Sildenafil normalizes bowel transit in preclinical models of constipation.