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Could a common adult IBS drug help kids? new trial aims to find out

NCT ID NCT03339128

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing the drug eluxadoline (Viberzi) in children aged 6 to 17 who have irritable bowel syndrome with diarrhea (IBS-D). The goal is to see if it improves stool consistency and is safe for kids. About 95 children will take either the drug or a placebo for 4 weeks, and researchers will track changes in their bathroom habits using a special scale.

What this could mean

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

Active substance
eluxadoline (Viberzi)
What this could lead to
If successful, this could provide a new treatment option for children with irritable bowel syndrome with diarrhea, helping to improve stool consistency and quality of life.
What could go wrong
This is an early phase 2 study with only 95 participants, so results may not apply to all children. The drug is already approved for adults, but its safety and effectiveness in kids are still unproven.

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

About 95 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

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 17 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: * Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures. * Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent. * Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must be able to read and understand the assessments in the eDiary and must undergo training. * Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. Female participants of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing. * Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. Local practices may require 2 methods of birth control. Female participants of non-childbearing potential do not need to use birth control. * Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following: \-- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following: * Related to defecation * A change in frequency of stool * A change in form (appearance) of stool * After appropriate evaluation, the symptoms cannot be fully explained by another medical condition. * Participant has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for more than 25% of bowel movements and Bristol stool types 1 or 2 for less than 25% of bowel movements that occur in the absence of laxative. * Participant may be newly diagnosed with IBS-D by the investigator at Visit 1. All criteria for diagnosis must be fulfilled for at least 2 months prior to Visit 1 (screening). * Participant has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization). * Participant has an average daytime abdominal pain score greater than or equal to 1.0 over the 2 weeks prior to randomization. * Participant has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks immediately prior to randomization and that occurs in the absence of laxatives. Exclusion Criteria: * Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy). * Participant has had any of the following surgeries: * Any abdominal surgery within the 3 months prior to Screening; or * A history of major gastric, hepatic, pancreatic, or intestinal surgery. (Note: appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed. For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.) * Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction. * Participant has a history or current diagnosis of constipation with encopresis. * Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation. * Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation. * Participant has a documented history of hepatic impairment as defined by Child-Pugh Classification Grade A, B or C. * Participant has a history or current diagnosis of inflammatory or immune-mediated lower GI disorders including inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, microscopic colitis). Crohn's disease affecting the upper GI tract would also be exclusionary. * Participant has celiac disease, or a positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy. * Participant has any congenital and/or acquired malabsorption syndrome (eg, Shwachman-Diamond syndrome). * Participant has a history of a microbiologically documented (ie, stool culture or medical history) GI infection within 3 months prior to Screening. * Participant has a known lactose or fructose intolerance that is associated with diarrhea, abdominal pain or discomfort, and that could confound assessments in the study. * Participant has a history of diverticulitis within 3 months prior to Screening.

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

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

Irritable bowel syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Children's Hospital-Park Ridge /ID# 235388

    COMPLETED

    Park Ridge, Illinois, 60068, United States

  • Applied Research Center of Arkansas /ID# 238070

    RECRUITING

    Little Rock, Arkansas, 72212-4187, United States

  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273

    COMPLETED

    Blackpool, FY3 8NR, United Kingdom

  • Celen Medical Group Corp /ID# 234922

    COMPLETED

    Marlton, New Jersey, 08053, United States

  • Centrum Zdrowia MDM /ID# 237269

    COMPLETED

    Warsaw, Masovian Voivodeship, 00-189, Poland

  • Children's Ctr Digestive, US /ID# 237575

    COMPLETED

    Atlanta, Georgia, 30342, United States

  • Children's Hospital of Philadelphia - Main /ID# 234313

    COMPLETED

    Philadelphia, Pennsylvania, 19104-4319, United States

  • Cook Children's Med. Center /ID# 237537

    COMPLETED

    Fort Worth, Texas, 76104, United States

  • Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656

    COMPLETED

    Gdansk, Pomeranian Voivodeship, 80-803, Poland

  • Duplicate_Academisch Medisch Centrum /ID# 237117

    COMPLETED

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Duplicate_Center for Clinical Trials LLC /ID# 234630

    COMPLETED

    Paramount, California, 90723, United States

  • Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917

    COMPLETED

    Edmonton, T6G 1C9, Canada

  • Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311

    COMPLETED

    Warsaw, Masovian Voivodeship, 04-730, Poland

  • Duplicate_Manchester University NHS Foundation Trust /ID# 234663

    COMPLETED

    Manchester, Lancashire, M13 9WL, United Kingdom

  • Duplicate_VVCRD Research /ID# 234606

    COMPLETED

    Garden Grove, California, 92845, United States

  • Duplicate_Wellness Clinical Research /ID# 237401

    COMPLETED

    Miami Lakes, Florida, 33016, United States

  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993

    COMPLETED

    Budapest, 1125, Hungary

  • Florida Research Center, Inc. /ID# 236514

    RECRUITING

    Miami, Florida, 33174, United States

  • Frederick County Pediatrics /ID# 234519

    COMPLETED

    New Market, Maryland, 21774-6154, United States

  • Global Research Associates /ID# 234646

    RECRUITING

    Atlanta, Georgia, 30315, United States

  • HELIOS Klinikum Wuppertal /ID# 237322

    COMPLETED

    Wuppertal, 42283, Germany

  • HealthStar Research of Hot Springs PLLC /ID# 234609

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • Hospital Universitario Dr. Peset /ID# 236755

    COMPLETED

    Valencia, 46017, Spain

  • IPS Research Company /ID# 237672

    COMPLETED

    Oklahoma City, Oklahoma, 73106, United States

  • Indiana University Health Riley Hospital for Children /ID# 235400

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Instytut Centrum Zdrowia Matki Polki /ID# 237438

    COMPLETED

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Kindred Medical Institute, LLC /ID# 237368

    COMPLETED

    Corona, California, 92879, United States

  • Kings College Hospital NHS Foundation Trust /ID# 236305

    COMPLETED

    London, Greater London, SE5 9RS, United Kingdom

  • Korczowski Bartosz Gabinet Lekarski /ID# 234683

    COMPLETED

    Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

  • MHATSv.Ivan Rilski /ID# 235399

    COMPLETED

    Kozloduy, 3320, Bulgaria

  • MNGI Digestive Health, P. A. /ID# 238057

    COMPLETED

    Minneapolis, Minnesota, 55413-2195, United States

  • Manitoba Institute of Child Health /ID# 235448

    COMPLETED

    Winnepeg, R3E 3P4, Canada

  • Medical center 1 Sevlievo /ID# 237473

    COMPLETED

    Sevlievo, Gabrovo, 5400, Bulgaria

  • Michael W. Simon, MD, PSC /ID# 236517

    COMPLETED

    Lexington, Kentucky, 40517, United States

  • Preferred Primary Care Physicians, Inc. /ID# 236436

    RECRUITING

    Pittsburgh, Pennsylvania, 15236, United States

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341

    COMPLETED

    Sopron, 9400, Hungary

  • South Miami Medical & Research Group Inc. /ID# 234655

    RECRUITING

    Miami, Florida, 33155, United States

  • Specjalistyczne Gabinety Sp. z o.o. /ID# 236347

    COMPLETED

    Krakow, Lesser Poland Voivodeship, 30-539, Poland

  • Sun Research Institute /ID# 236933

    COMPLETED

    San Antonio, Texas, 78215, United States

  • Sunrise Research Institute /ID# 237382

    COMPLETED

    Miami, Florida, 33130, United States

  • Texas Children's Hospital /ID# 238304

    RECRUITING

    Houston, Texas, 77030-2608, United States

  • University Hospital Plovdiv /ID# 235450

    COMPLETED

    Plovdiv, 4001, Bulgaria

  • Valencia Medical & Research Center /ID# 234672

    RECRUITING

    Miami, Florida, 33165, United States

  • Vita Verum Medical Bt. /ID# 234321

    COMPLETED

    Székesfehérvár, 8000, Hungary

  • West Virginia University Hospitals /ID# 256841

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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