Clinical trials: Ulcerative Colitis, Pediatric
Ulcerative Colitis
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects…
- Trial name
- NCT04314375
- Testing
- Low Dose Budesonide, High Dose Budesonide
- Where
- 4 sites in United States
- Volunteers
- 70 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
- Trial name
- NCT04779307
- Testing
- Vedolizumab
- Where
- 65 sites in United States, Australia and 12 more
- Volunteers
- 121 people
- Sponsor
- Takeda
Crohn Disease, Ulcerative Colitis
Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric…
- Conditions
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- Trial name
- NCT04522271
- Testing
- Resistant Starch
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Children's Hospital of Eastern Ontario
Ulcerative Colitis
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years.
- Trial name
- Galapeduca (NCT06865417)
- Testing
- Filgotinib
- Where
- 46 sites in Belgium, Croatia and 11 more
- Volunteers
- 80 people
- Sponsor
- Alfasigma S.p.A.
Ulcerative Colitis
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.
- Trial name
- NCT00349388
- Testing
- Asacol
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Annette Langseder
Ulcerative Colitis, Crohn's Disease
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in pediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).
- Trial name
- FENNEL (NCT03478956)
- Testing
- Etrolizumab
- Where
- 5 sites in Belgium, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an…
- Trial name
- NCT05976802
- Testing
- High dose budesonide rectal foam, Low dose budesonide rectal foam
- Volunteers
- 100 people
- Sponsor
- Bausch Health Americas, Inc.
Inflammatory Bowel Diseases, Colitis, Ulcerative
Therapeutic Endpoint in Pediatric IBD Conditions
The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative…
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT06065228
- Testing
- AlgometRx Nociometer
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Children's National Research Institute
Inflammatory Bowel Disease, Crohn's Disease
ENhanced Recovery in CHildren Undergoing Surgery
The institution of perioperative Enhanced Recovery Protocols (ERPs) has been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but data in pediatric populations are…
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- Trial name
- ENRICH-US (NCT04060303)
- Testing
- Perioperative surgical care
- Where
- United States
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- SHINE-2 (NCT05784246)
- Testing
- Mirikizumab IV, Mirikizumab SC
- Where
- 34 sites in United States, Belgium and 9 more
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Inflammatory Bowel Disease, Ulcerative Colitis
Pediatric FEcal Microbiota Transplant for Ulcerative Colitis
The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbiota transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory bowel disease-unclassified (IBD-U).
- Trial name
- PediFETCh (NCT02487238)
- Testing
- Fecal Microbiota Enema, Normal Saline Enema
- Where
- 3 sites in Canada
- Volunteers
- 35 people
- Sponsor
- McMaster Children's Hospital
IBD, Crohn Disease (CD)
Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs).
- Conditions
- IBD, Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
- Trial name
- NCT07224113
- Testing
- Handout-Only Intervention, Handout + Video Intervention
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Connecticut Children's Medical Center
Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease
Exercise Training in Youth With Inflammatory Bowel Disease
Children and adolescents with inflammatory bowel disease (IBD) suffer from many extra-intestinal side effects, including impaired muscle strength, low aerobic fitness, low bone density, and chronic inflammation.
- Conditions
- Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
- Trial name
- NCT05591976
- Testing
- Exercise training program
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- McMaster University
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02065557
- Testing
- Adalimumab
- Where
- 60 sites in United States, Australia and 12 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Inflammatory Bowel Diseases
An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain…
- Trial name
- ADAPT (NCT02566889)
- Testing
- Infliximab
- Where
- 36 sites in United States, Canada
- Volunteers
- 53 people
- Sponsor
- Janssen Scientific Affairs, LLC
Ulcerative Colitis, Crohn's Disease
Development of 'Emma'--a Pediatric IBD Quiz
We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education.
- Conditions
- Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease
- Trial name
- NCT02065089
- Testing
- playing the ipad quiz game
- Where
- 2 sites in United States
- Volunteers
- 116 people
- Sponsor
- Mayo Clinic
Ulcerative Colitis
Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab
This is a multicenter, double-blind, randomized study to compare the safety, effectiveness and immunogenicity (antibodies against drug) of two biological drugs administered intravenously - vedolizumab (a drug not registered in…
- Trial name
- VEDI-UC (NCT06614387)
- Testing
- Infliximab
- Volunteers
- 60 people
- Sponsor
- JAROSLAW KIERKUS
Crohn Disease, Ulcerative Colitis
Transcutaneous VNS to Treat Pediatric IBD
The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect.
- Trial name
- STIMIBD (NCT03863704)
- Testing
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Northwell Health
Ulcerative Colitis, Crohn's Disease
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time.
- Trial name
- NCT06405087
- Testing
- Vedolizumab SC, No Intervention
- Where
- 47 sites in United States, Belgium and 12 more
- Volunteers
- 70 people
- Sponsor
- Takeda
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC