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New hope for toddlers with chronic constipation?

NCT ID NCT05652205

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug linaclotide in children aged 2 to 5 years with functional constipation, a common condition with no approved treatments. In the first part, children received either linaclotide or a placebo for 12 weeks to see if it increased bowel movements. In the second part, all children received linaclotide for 24 weeks to check long-term safety. The goal is to find a safe and effective treatment for this age group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Linaclotide
What this could lead to
If successful, this could provide a new, approved treatment option for young children with chronic constipation.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not show significant benefit over placebo, and side effects like diarrhea are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

123 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Caregiver/parent/guardian/legally authorized representative (LAR) is willing and able to comply with procedures required in this protocol, prior to the initiation of any screening or study-specific procedures. In addition, the caregiver/parent/guardian/LAR who will be completing the electronic diary (eDiary) must be able to read and understand the assessments in the eDiary device and undergo training. * Participant meets modified Rome IV criteria for FC: For at least 1 month before Screening (Visit 1), the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) per week. In addition, at least once per week, participant must meet 1 or more of the following: * History of retentive posturing or excessive volitional stool retention. * History of painful or hard bowel movements (BMs). * Presence of a large fecal mass in the rectum. * History of large diameter stools. * At least 1 episode of fecal incontinence per week after the acquisition of toileting skills, if applicable. Exclusion Criteria: * Participant history of: * Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy * Cystic fibrosis * Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to Screening (Visit 1) * Down's syndrome or any other chromosomal disorder * Active anal fissure (i.e., participant reports having streaks of blood on the stool or on toilet paper and/or pain/crying with BM within 2 weeks prior to Screening). (Note: anal fissures that have resolved at least 2 weeks prior to screening would not be exclusionary.) However, if in the investigator's opinion, an anal fissure(s) may be the primary cause of participant's modified Rome IV FC criteria, the participant would not be eligible to participate in the study. * Anatomic malformations (e.g., imperforate anus, anal stenosis, anterior displaced anus) * Intestinal nerve or muscle disorders (e.g., Hirschprung disease, visceral myopathies, visceral neuropathies) * Neuropathic conditions (e.g., spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma) * Lead toxicity, hypercalcemia * Inflammatory bowel disease * Childhood functional abdominal pain syndrome * Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study * Lactose intolerance that is associated with symptoms which could confound the assessments in this study * History of cancer. (Note: participants with a history of cancer are allowed provided that the malignancy has been in a complete remission before Randomization (Visit 2). A complete remission is defined as the disappearance of all signs of cancer in response to treatment.) * Has conditions that could interfere with drug absorption including but not limited to short bowel syndrome.

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Conditions

The condition(s) this trial relates to.

constipation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic idiopathic constipation (CIC) Functional constipation (FC)

Contacts and locations

Locations

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 251234

    Sofia, 1407, Bulgaria

  • Advanced Research Center /ID# 249412

    Anaheim, California, 92805, United States

  • Amphia Ziekenhuis /ID# 251698

    Breda, North Brabant, 4818 CK, Netherlands

  • Amsterdam UMC, locatie AMC /ID# 251295

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Applied Research Center of Arkansas /ID# 249764

    Little Rock, Arkansas, 72212-4187, United States

  • Carilion Medical Center /ID# 249790

    Roanoke, Virginia, 24014, United States

  • ClinPoint Trials /ID# 250448

    Waxahachie, Texas, 75165-1430, United States

  • Coastal Pediatric Research - Summerville /ID# 249423

    Summerville, South Carolina, 29486, United States

  • Coastal Pediatric Research - West Ashley B /ID# 249413

    Charleston, South Carolina, 29414, United States

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 251179

    London, Greater London, E1 2ES, United Kingdom

  • Doncaster Royal Infirmary /ID# 252080

    Armthorpe Road, DN2 5LT, United Kingdom

  • Frederick County Pediatrics /ID# 249483

    New Market, Maryland, 21774-6154, United States

  • Frontier Clinical Research - Kingwood /ID# 251154

    Kingwood, West Virginia, 26537-9797, United States

  • Frontier Clinical Research - Smithfield /ID# 250657

    Smithfield, Pennsylvania, 15478, United States

  • Frontier Clinical Research, LLC - Scottdale /ID# 250656

    Scottdale, Pennsylvania, 15683, United States

  • G & L Research, LLC /ID# 250658

    Foley, Alabama, 36535, United States

  • HealthStar Research of Hot Springs PLLC /ID# 249481

    Hot Springs, Arkansas, 71913, United States

  • Houston Clinical Research Associates /ID# 250779

    Houston, Texas, 77090-2633, United States

  • IPS Research Company /ID# 250822

    Oklahoma City, Oklahoma, 73106, United States

  • KIDZ Medical Services - Hollywood /ID# 250823

    Hollywood, Florida, 33021-6030, United States

  • Kindred Medical Institute - Corona /ID# 249485

    Corona, California, 92879-3104, United States

  • Kissimmee Clinical Research /ID# 252206

    Kissimmee, Florida, 34741, United States

  • MNGI Digestive Health, P. A. /ID# 249676

    Minneapolis, Minnesota, 55413-2195, United States

  • Medical Ctr for Clin Research /ID# 254386

    San Diego, California, 92108, United States

  • Michael W. Simon, MD, PSC /ID# 250664

    Lexington, Kentucky, 40517, United States

  • Michigan Center of Medical Research /ID# 251088

    Farmington Hills, Michigan, 48334, United States

  • Nemours Children's Health System /ID# 250881

    Jacksonville, Florida, 32207, United States

  • Northern Licolnshire and Goole NHS Foundation Trust /ID# 252007

    Grimsby, DN33 2BA, United Kingdom

  • Nova Clinic /ID# 250816

    Varna, 9000, Bulgaria

  • Palmetto Professional Research /ID# 250875

    Miami, Florida, 33172, United States

  • Prime Clinical Research - Mansfield - East Broad Street /ID# 266236

    Mansfield, Texas, 76063, United States

  • Prohealth Research Center /ID# 249420

    Doral, Florida, 33166, United States

  • Rophe Adult & Pediatric Medicine /ID# 250663

    Union City, Georgia, 30291, United States

  • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 250876

    Newark, New Jersey, 07103-2425, United States

  • South Florida Research Ph I-IV /ID# 252350

    Miami Springs, Florida, 33166-7225, United States

  • South Miami Medical & Research Group Inc. /ID# 249418

    Miami, Florida, 33155, United States

  • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251233

    Sofia, 1606, Bulgaria

  • Tribe Clinical Research LLC /ID# 255656

    Greenville, South Carolina, 29607-4021, United States

  • Tullahoma Pediatrics /ID# 250892

    Tullahoma, Tennessee, 37388, United States

  • UH Cleveland Medical Center /ID# 250893

    Cleveland, Ohio, 44106, United States

  • UMHAT Kanev /ID# 250815

    Rousse, 7002, Bulgaria

  • Univ NC Chapel Hill /ID# 252044

    Chapel Hill, North Carolina, 27514-4220, United States

  • University Hospital Plovdiv /ID# 250814

    Tsentar, Plovdiv, 4001, Bulgaria

  • Valencia Medical & Research Center /ID# 250452

    Miami, Florida, 33165, United States

  • Velocity Clinical Research - Lafayette /ID# 266751

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research - Phoenix /ID# 266280

    Phoenix, Arizona, 85006, United States

  • Velocity Clinical Research Macon /ID# 266516

    Macon, Georgia, 31210-6583, United States

  • Velocity Clinical Research- Hastings Nebraska /ID# 252132

    Hastings, Nebraska, 68901-2640, United States

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