Clinical trials: Pediatric Inflammatory Bowel Diseases
Crohn Disease
Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease.
The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential…
- Trial name
- NCT06324513
- Testing
- Mediterranean Crohn's Disease Exclusion Diet (Med-CDED), Crohn's disease exclusion diet (CDED)
- Where
- 3 sites in Italy
- Volunteers
- 120 people
- Sponsor
- Meyer Children's Hospital IRCCS
Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Inflamatory Bowel Disease
Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease
Pediatric inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic condition associated not only with intestinal inflammation but also with reduced physical fitness, fatigue, impaired…
- Trial name
- PAFIT-IBD (NCT07484620)
- Testing
- Physical Activity Intervention
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Universidad Complutense de Madrid
IBD
Biofeedback in Pediatric Inflammatory Bowel Disease
This prospective, randomized, longitudinal, controlled project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to…
- Trial name
- NCT04269720
- Testing
- Biofeedback
- Sponsor
- Ross Maltz
Acute Kidney Injury, Sepsis
Novel Biomarkers for Early Renal Injury in Children With Sepsis
Toxicosis often leads to multiple organ failure (MODS), with the kidney being the primary target organ due to its sensitivity to infection and ischemia.
- Conditions
- Acute Kidney Injury, Sepsis, Gout Flare
- Trial name
- NCT06197828
- Testing
- This study is an observational studie which have no intervention
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Crohns Disease, Colitis, Ulcerative
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile…
- Conditions
- Crohns Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile
- Trial name
- TRILOGY (NCT06663332)
- Testing
- Guselkumab
- Where
- 51 sites in United States, Argentina and 15 more
- Volunteers
- 196 people
- Sponsor
- Janssen Research & Development, LLC
Mental Health Issue, Inflammatory Bowel Diseases
RxWell in Pediatric IBD for Disease Management and Transition Readiness
Evaluate the feasibility and acceptability of adapted coached RxWell for patients ages 16-25. Adapt and beta test the modified RxWell product to include chronic disease management and transition readiness.
- Trial name
- NCT05461014
- Testing
- dCBI
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Pittsburgh
Crohn Disease, Ulcerative Colitis
Transcutaneous VNS to Treat Pediatric IBD
The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect.
- Trial name
- STIMIBD (NCT03863704)
- Testing
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Northwell Health
Ulcerative Colitis, Crohn Disease
Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents
The purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering…
- Conditions
- Ulcerative Colitis, Crohn Disease, Depression, Sleep
- Trial name
- Ex-CED (NCT02264275)
- Testing
- Aerobic Exercise Training
- Where
- 3 sites in Switzerland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Basel
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
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
Ulcerative Colitis
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
- Trial name
- NCT02632175
- Testing
- Adalimumab
- Where
- 16 sites in United States, Japan and 4 more
- Volunteers
- 59 people
- Sponsor
- AbbVie
Crohn Disease
Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease
The purpose of this study is to observe pediatric Crohn's Disease response to sargramostim in patients with or without steroid therapy at two possible dosage levels.
- Trial name
- NCT00206661
- Testing
- Sargramostim (Leukine)
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- Genzyme, a Sanofi Company
Crohn's Disease
Nutritional Therapy Study in Pediatric Crohn's Disease
The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Crohn's Disease (CD).
- Trial name
- NCT02610101
- Testing
- Traditional SCD Diet, Modified SCD Diet, Whole foods diet
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Seattle Children's Hospital
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
Crohn Disease, Ulcerative Colitis
Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric…
- Conditions
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- Trial name
- NCT04522271
- Testing
- Resistant Starch
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Children's Hospital of Eastern Ontario
Ulcerative Colitis
Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab
This is a multicenter, double-blind, randomized study to compare the safety, effectiveness and immunogenicity (antibodies against drug) of two biological drugs administered intravenously - vedolizumab (a drug not registered in…
- Trial name
- VEDI-UC (NCT06614387)
- Testing
- Infliximab
- Volunteers
- 60 people
- Sponsor
- JAROSLAW KIERKUS
Crohn's Disease, Protein Metabolism
Protein and Energy Metabolism in Pediatric Crohn's Disease
The metabolic response to Crohn's disease, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer.
- Conditions
- Crohn's Disease, Protein Metabolism, Energy Metabolism
- Trial name
- NCT00583232
- Testing
- Stable isotope infusions
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Indiana University
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin…
- Trial name
- NCT06100289
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 54 sites in United States, Belgium and 14 more
- Volunteers
- 70 people
- Sponsor
- Takeda
Inflammatory Bowel Diseases
Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease
Objectives: To assess the predictive value of IUS in children with IBD. Design: A prospective longitudinal cohort study. Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital.
- Trial name
- SPIBDUS (NCT03026582)
- Testing
- Intestinal ultra-sound monitoring
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Schneider Children's Medical Center, Israel
Pediatric Crohns Disease
TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease
This clinical trail intends to evaluate interventions based on the Infliximab trough levels for an individualized therapy adaption for pediatric IBD-patients undergoing anti-TNF-alpha-therapy.
- Trial name
- TOPIT (NCT02522169)
- Testing
- Infliximab
- Volunteers
- 120 people
- Sponsor
- Klinikum Westbrandenburg GmbH