Clinical trials: Pediatric Inflammatory Bowel Diseases
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
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
Inflammatory Bowel Disease, Crohn's Disease
A Trial of Yoga in Pediatric Inflammatory Bowel Disease
IBD adds additional stressors as a chronic disease that has unpredictable and sometimes embarrassing symptoms to the normal challenges that teenagers face.
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- Trial name
- NCT03338894
- Testing
- Yoga
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Atlantic Health System
IBD
Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children
Most of the studies evaluating the roles of MRE and WCE conducted in pediatric patients have been retrospective with the main goal of making a diagnosis in patients with suspected IBD.
- Trial name
- CE (NCT02182947)
- Testing
- Capsule endoscopy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Children's Mercy Hospital Kansas City
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 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
Inflammatory Bowel Diseases
Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease
In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies.
- Trial name
- NCT02150551
- Testing
- Allogeneic bone marrow-derived mesenchymal stromal cells
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Catherine Bollard
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
Crohn's Disease
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
- Trial name
- NCT00409682
- Testing
- Adalimumab
- Where
- 45 sites in United States, Belgium and 6 more
- Volunteers
- 192 people
- Sponsor
- Abbott
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
Inflammatory Bowel Disease, Crohn's Disease
Bacteriotherapy in Pediatric Inflammatory Bowel Disease
In this study, the investigators want to see if Bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with Inflammatory Bowel Disease (IBD).
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, CD
- Trial name
- NCT01757964
- Testing
- Bacteriotherapy
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- David Suskind
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
Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD)
Fecal Microbiota Transplantation in Pediatric Patients
A disturbance in the diversity of gut bacterial composition could be linked to several immune mediated diseases including inflammatory bowel diseases (IBD).
- Conditions
- Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD), Ulcerative Colitis (UC)
- Trial name
- FMT (NCT02108821)
- Testing
- Fecal Microbiota Transplantation (FMT)
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
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
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
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohn's disease (CD) and to gather…
- Trial name
- NCT00686374
- Testing
- Adalimumab
- Volunteers
- 100 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Inflammatory Bowel Disease
The Pediatric Intermed: A New Clinical Decision Making Tool
The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth.
- Trial name
- NCT01781481
- Where
- Canada
- Volunteers
- 148 people
- Sponsor
- Children's Hospital of Eastern Ontario
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
Inflammatory Bowel Diseases, Ulcerative Colitis
Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30…
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- Trial name
- NCT02330653
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Stacy A. Kahn