Clinical trials: Pediatric Inflammatory Bowel Diseases
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.
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.
Clostridium Difficile, Inflammatory Bowel Disease
Fecal Microbiome Transplant
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD) The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric…
- Conditions
- Clostridium Difficile, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- Trial name
- NCT02636517
- Testing
- Fecal Microbiota Transplant
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Judith Kelsen
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
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention.
- Trial name
- AMAY (NCT05509777)
- Testing
- Mirikizumab
- Where
- 81 sites in United States, Austria and 14 more
- Volunteers
- 90 people
- Sponsor
- Eli Lilly and Company
Inflammatory Bowel Diseases
Ganglioside and IBD
Context. Inflammatory bowel disease (IBD) is a chronic and debilitating disorder. Novel treatment strategies aimed to resolve intestinal inflammation and induce disease remission are necessary.
- Trial name
- NCT04782544
- Testing
- Buttermilk Powder, Anhydrous Milk Fat
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Children's Hospital of Orange County
Crohn's Disease
The ImageKids Study: Developing the pMEDIC and the PICMI
The overall objectives of this study are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's disease by means of Magnetic Resonance Imaging with…
- Trial name
- NCT01881490
- Testing
- MRE
- Where
- Israel
- Volunteers
- 240 people
- Sponsor
- Shaare Zedek Medical Center
Crohn Disease
Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease
To evaluate the clinical manifestations, treatment options, and improved clinical outcomeof children with Crohn's disease in real-world Settings: (1) analysis of clinical manifestations; (2) probability of using the same…
- Trial name
- CD (NCT06673134)
- Testing
- enteral nutrition, Immunotherapy, biological agents
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
Inflammatory Bowel Diseases
Therapeutic Monitoring of Infliximab and Adalimumab
Anti tumor necrosis factor (TNF agents), particularly infliximab and adalimumab, changed the way chronic inflammatory bowel disease (IBD) refractory to conventional therapies is treated, including in pediatric patients.
- Trial name
- NCT06033469
- Testing
- Infliximab, Adalimumab
- Where
- 3 sites in Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Burlo Garofolo
Inflammatory Bowel Diseases
Treating IBD With Inulin
The purpose of this study is to see how the prebiotic inulin changes the gut bacteria (microbiome) of children and young adults with IBD and determine if this dietary intervention can help reduce disease activity.
- Trial name
- TII (NCT03653481)
- Testing
- Oligofructose-enriched Inulin OI, Maltodextrin
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Children's Hospital of Philadelphia
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
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The study is an extension of two parent studies (MLN0002-3024 [NCT04779307] and MLN0002-3025 [NCT04779320]). Participants must have participated in one of the previous studies.
- Trial name
- NCT05442567
- Testing
- Vedolizumab IV, No Intervention
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 240 people
- Sponsor
- Takeda
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
Crohn Disease
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is…
- Trial name
- STELARA (NCT02968108)
- Testing
- Ustekinumab
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 45 people
- Sponsor
- Janssen Research & Development, 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)
Ulcerative Colitis
Bleach and Urine Color in UC Patients Using 5ASA
The aim of this study is to evaluate the effect on urine color by adding household bleach to fresh urine sample among pediatric UC subjects treated with 5ASA
- Trial name
- Asableach (NCT06013696)
- Testing
- Adding household bleach to urine sample
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Meir Medical Center
Crohn's Disease, Osteopenia
Zoledronate for Osteopenia in Pediatric Crohn's
Background: Up to 30% of children and adolescents with Crohn's disease have decreased bone strength, or decrease bone density, called osteopenia.
- Conditions
- Crohn's Disease, Osteopenia, Osteoporosis
- Trial name
- NCT00798473
- Testing
- zoledronic acid, IV saline infusion
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Pediatric Crohn's Disease, Pediatric Ulcerative Colitis
Mission is Remission®: How Can a Disease Self-management Website Change Care?
Crohn's disease and ulcerative colitis, known together as inflammatory bowel disease (IBD), are chronic inflammatory conditions of the gastrointestinal tract.
- Trial name
- NCT02694042
- Testing
- Mission is Remission®
- Volunteers
- 39 people
- Sponsor
- IWK Health Centre
Crohn's Disease, Ulcerative Colitis
Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA
The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the…
- Trial name
- NCT06856135
- Testing
- Vedolizumab IV
- Where
- 3 sites in United States
- Sponsor
- Takeda
Crohn Disease
Fecal Microbiota Transplantation in Pediatric Crohn's Disease
This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment
- Trial name
- FMT (NCT05321745)
- Testing
- Standardized FMT
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Biao Zou