Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could this drug ease constipation in the littlest ones?

NCT ID NCT05760313

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a medicine called linaclotide in 19 babies and toddlers (6 months to under 2 years old) with long-term constipation. The goal was to see if it helps them have more bowel movements and softer stools, and to check for side effects. Children took the medicine as a liquid once a day for 4 weeks. Some children received a placebo (a dummy treatment) instead.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Apr 2023

Finished

Jun 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

6 to 23 months

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: * 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. * The LAR/parent/guardian who will be completing the electronic diary (eDiary) is able to read and understand the assessments in the eDiary device and must undergo training. * Participant meets Rome IV criteria for functional constipation (FC): for at least 1 month before Screening (Visit 1), the participant must meet 2 or more of the following: * 2 or fewer defecations per week (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) * History of excessive stool retention * History of painful or hard bowel movements (BMs) * History of large-diameter stools * Presence of a large fecal mass in the rectum * LAR/Parent/Guardian is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol-permitted rescue medicine. Exclusion Criteria: * Participant has conditions that could interfere with drug absorption, including, but not limited to, short bowel syndrome. * History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the individual's participation in this study or would make the participant an unsuitable candidate to receive study drug. * Participant has 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 (investigator has confirmed an active anal fissure and participant reports known anal fissure symptoms \[i.e., streaks of blood on the stool or on diaper or toilet paper and pain/crying with bowel movement within 2 weeks prior to Screening\]). (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 Rome IV FC criteria, the subject 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 * 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 enrollment/randomization (Visit 3). A complete remission is defined as the disappearance of all signs of cancer in response to treatment)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Functional constipation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Functional constipation

Contacts and locations

Locations

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 251232

    Sofia, 1407, Bulgaria

  • Advanced Research Center /ID# 248763

    Anaheim, California, 92805, United States

  • ClinPoint Trials /ID# 251534

    Waxahachie, Texas, 75165-1430, United States

  • Coastal Pediatric Research - Summerville /ID# 253534

    Summerville, South Carolina, 29486, United States

  • Coastal Pediatric Research - West Ashley B /ID# 248693

    Charleston, South Carolina, 29414, United States

  • Debreceni Egyetem-Klinikai Kozpont /ID# 250793

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 252298

    London, Greater London, E1 2ES, United Kingdom

  • Frederick County Pediatrics /ID# 251555

    New Market, Maryland, 21774-6154, United States

  • Great Ormond Street Children's Hospital /ID# 253333

    London, Greater London, WC1N 3HZ, United Kingdom

  • HELIOS Klinikum Wuppertal /ID# 249022

    Wuppertal, 42283, Germany

  • HealthStar Research of Hot Springs PLLC /ID# 251553

    Hot Springs, Arkansas, 71913, United States

  • Houston Clinical Research Associates /ID# 261571

    Houston, Texas, 77090-2633, United States

  • Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 252485

    Belgrade, Beograd, 11000, Serbia

  • Institute for Child and Youth Health Care of Vojvodina /ID# 252482

    Novi Sad, 21000, Serbia

  • Kinderarztpraxis Dr. Froehlich /ID# 252050

    Forchheim, 91301, Germany

  • Kindred Medical Institute - Corona /ID# 251535

    Corona, California, 92879-3104, United States

  • Klinicki bolnicki centar Osijek /ID# 252795

    Osijek, County of Osijek-Baranja, 31000, Croatia

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 252798

    Zagreb, City of Zagreb, 10000, Croatia

  • Klinicki bolnicki centar Zagreb /ID# 252796

    Zagreb, City of Zagreb, 10000, Croatia

  • Klinika za dječje bolesti Zagreb /ID# 252792

    Zagreb, City of Zagreb, 10000, Croatia

  • Michigan Center of Medical Research /ID# 253536

    Farmington Hills, Michigan, 48334, United States

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252299

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Nova Clinic /ID# 249023

    Varna, 9000, Bulgaria

  • Prime Clinical Research - Mansfield - East Broad Street /ID# 262947

    Mansfield, Texas, 76063, United States

  • Prohealth Research Center /ID# 248696

    Doral, Florida, 33166, United States

  • Russells Hall Hospital /ID# 252660

    Dudley, DY1 2HQ, United Kingdom

  • South Miami Medical & Research Group Inc. /ID# 248765

    Miami, Florida, 33155, United States

  • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251229

    Sofia, 1606, Bulgaria

  • UMHAT Kanev /ID# 248931

    Rousse, 7002, Bulgaria

  • UMHAT Sveti Georgi /ID# 250808

    Plovdiv, 4002, Bulgaria

  • Universitaetsklinikum Muenster /ID# 251965

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Children's Hospital 'Tirsova' /ID# 252483

    Belgrade, Beograd, 11000, Serbia

  • Valencia Medical & Research Center /ID# 251533

    Miami, Florida, 33165, United States

  • Velocity Clinical Research - Lafayette /ID# 263873

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research - Phoenix /ID# 263871

    Phoenix, Arizona, 85006, United States

  • Velocity Clinical Research Macon /ID# 263959

    Macon, Georgia, 31210-6583, United States

  • Velocity Clinical Research Washington DC /ID# 263872

    Washington D.C., District of Columbia, 20016-4300, United States

  • Velocity Clinical Research- Hastings Nebraska /ID# 260932

    Hastings, Nebraska, 68901-2640, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.