Clinical trials: Pediatric Crohns Disease
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, 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
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
Pediatric Crohn's Disease
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea.
- Trial name
- NCT02578238
- Volunteers
- 143 people
- Sponsor
- AbbVie
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, Complex Perianal Fistula
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
- Trial name
- NCT04701411
- Testing
- Darvadstrocel
- Where
- 22 sites in Israel, Japan and 3 more
- Volunteers
- 7 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
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
Crohn Disease
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure…
- Trial name
- UNITI Jr (NCT04673357)
- Testing
- Ustekinumab
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 101 people
- Sponsor
- Janssen Research & Development, LLC
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
Pediatric Crohn's Disease
Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with…
- Trial name
- COMBINE (NCT02772965)
- Testing
- Methotrexate
- Where
- 32 sites in United States
- Volunteers
- 306 people
- Sponsor
- University of North Carolina, Chapel Hill
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
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
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)
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
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
Crohn's Disease
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that…
- Trial name
- NCT00109473
- Testing
- growth hormone, cortecosteroid
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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