Clinical trials: Ulcerative Colitis, Pediatric
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
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
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
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
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab.
- Trial name
- SHINE-1 (NCT04004611)
- Testing
- Mirikizumab
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
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
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
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
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
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
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
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 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
Inflammatory Bowel Disease (IBD)
Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure.
- Trial name
- GMT (NCT01560819)
- Testing
- Gut Microbial Transplantation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Corewell Health West
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.
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
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
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