Clinical trials: Pediatric Inflammatory Bowel Diseases
Inflammatory Bowel Diseases, Psychological
Stress in Inflammatory Bowel Disease
This is a prospective, assessment-based study to examine the relationship between psychophysiological functioning and psychological symptoms in youth newly diagnosed with inflammatory bowel disease (IBD) compared to healthy…
- Trial name
- NCT05202418
- Testing
- Biofeedback Enhanced Treatment
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Emory University
Ulcerative Colitis, Crohn's Disease
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
- Trial name
- NCT03138655
- Testing
- Vedolizumab
- Where
- 88 sites in United States, Belgium and 9 more
- Volunteers
- 89 people
- Sponsor
- Takeda
Crohn Disease, Pediatric Crohns Disease
Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to…
- Trial name
- PAZAZ (NCT04186247)
- Testing
- Azithromycin, Metronidazole, Standard of Care
- Where
- 5 sites in United States, Canada and 2 more
- Volunteers
- 13 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
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
Pediatric Crohns Disease, Pediatric Ulcerative Colitis
Peer Mentoring to Improve Self-management in Youth With IBD
This study is a multi-site randomized controlled clinical trial evaluating the efficacy of a peer mentoring program for improving the self-management of youth with IBD.
- Conditions
- Pediatric Crohns Disease, Pediatric Ulcerative Colitis, Inflammatory Bowel Diseases
- Trial name
- NCT03827109
- Testing
- Group educational activities, IBD educational website, Monthly check-in calls from program coordinator
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Kelly Boone
Crohn Disease
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
The purpose of this 12-month double blind, placebo controlled randomized trial is to evaluate the effects of daily treatments with low magnitude mechanical stimuli on bone in 160 children with Crohn disease.
- Trial name
- NCT00364130
- Testing
- Low magnitude mechanical stimulus
- Where
- United States
- Volunteers
- 138 people
- Sponsor
- Children's Hospital of Philadelphia
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
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
Predicting Response to Standardized Pediatric Colitis Therapy
This is a multi-center, open-label study to determine the safety and effectiveness (how well it works) of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in children with newly diagnosed Ulcerative…
- Trial name
- PROTECT (NCT01536535)
- Testing
- Mesalazine, IV Corticosteroid, Oral Corticosteroids
- Where
- 29 sites in United States, Canada
- Volunteers
- 431 people
- Sponsor
- Connecticut Children's Medical Center
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
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
Ulcerative Colitis, Crohn's Disease
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
- Trial name
- NCT03196427
- Testing
- Vedolizumab
- Where
- 23 sites in United States, France and 5 more
- Volunteers
- 59 people
- Sponsor
- Takeda
Crohn's Disease
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing endogenous enkephalin levels in subjects with active Crohn's disease.
- Trial name
- LDN-Ped (NCT00715117)
- Testing
- Naltrexone
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Milton S. Hershey Medical Center
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50…
- Trial name
- NCT00495521
- Testing
- 4-Aminosalicylic acid extended release granules
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Jacobus Pharmaceutical
Crohn Disease
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT05470985
- Testing
- Ozanimod
- Where
- 46 sites in United States, Australia and 7 more
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb