Clinical trials: Short Bowel
Short Bowel Syndrome
A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
The main aims of the study are to check for side effects from teduglutide. Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks.
- Trial name
- NCT05027308
- Testing
- Teduglutide
- Where
- 6 sites in Japan
- Volunteers
- 3 people
- Sponsor
- Takeda
Short Bowel Syndrome
Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous…
- Trial name
- NCT03663582
- Testing
- Teduglutide, Syringe, Needle
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Shire
Short Bowel Syndrome
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS.
- Trial name
- NCT02340819
- Testing
- Teduglutide
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Shire
Short Bowel Syndrome
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on…
- Trial name
- NCT02682381
- Testing
- Teduglutide 0.05mg/kg, Teduglutide 0.025 mg/kg, Standard of Care
- Where
- 27 sites in United States, Belgium and 5 more
- Volunteers
- 59 people
- Sponsor
- Shire
Short Bowel Syndrome
Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period.
- Trial name
- NCT02949362
- Testing
- Teduglutide, SOC
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 29 people
- Sponsor
- Shire
Short Bowel Syndrome
Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.
- Trial name
- NCT03571516
- Testing
- Teduglutide, Standard Medical Therapy, Syringe
- Where
- 8 sites in Finland, France and 2 more
- Volunteers
- 10 people
- Sponsor
- Shire
Arthritis, Juvenile Rheumatoid, Crohn Disease
Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
The investigators hypothesize that the anabolic effects of Genotropin (somatropin) will improve the height and weight of children with inflammatory based chronic illness who have failed to grow despite receiving adequate…
- Trial name
- NCT00511329
- Testing
- somatropin [rDNA origin] for injection
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Nationwide Children's Hospital
Short Bowel Syndrome
An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed…
- Trial name
- NCT03596164
- Testing
- Teduglutide, Syringe, Needle
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Takeda
Short Bowel Syndrome
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS).
- Trial name
- NCT02954458
- Testing
- TED, SOC, Syringe
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 61 people
- Sponsor
- Shire
Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome
Cholestasis Reversal: Efficacy of IV Fish Oil
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
- Conditions
- Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome, Gastrointestinal Disease
- Trial name
- Reversal (NCT00910104)
- Testing
- Omegaven®
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Mark Puder
Short Bowel Syndrome
Safety and Efficacy Study in Infant With SBS
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection
- Trial name
- GIFT (NCT02865122)
- Testing
- NTRA-9620
- Where
- 8 sites in United States
- Volunteers
- 2 people
- Sponsor
- Elgan Pharma Ltd.
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Central Line Complication, Central Line Infection
Innovative Central Line Securement Device in the Pediatric Population
This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a…
- Conditions
- Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis
- Trial name
- NCT04522778
- Testing
- Wearable Central Line Securement Device (Vest), Traditional Securement Dressing
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Ryan St. Pierre-Hetz
Short Bowel Syndrome
rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome
The primary research question is, in patients with short bowel syndrome requiring central venous access device (CVAD) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtPA) lock…
- Trial name
- NCT02355743
- Testing
- rtPA lock therapy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Lynn Malec
Short Bowel Syndrome
Use of Pancreatic Enzymes in Short Bowel Syndrome
Patients with short bowel syndrome have a high mortality rate that is mainly attributed to complications from central lines and long-term intravenous (IV) nutrition.
- Trial name
- SBS (NCT03097029)
- Testing
- Pancreatic Enzyme
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Children's Hospital of Philadelphia
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Short Bowel Syndrome
Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .
- Trial name
- NCT03105362
- Testing
- Enterade® oral rehydration solution
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Boston Children's Hospital
Short Gut Syndrome
Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure
Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods.
- Trial name
- NCT04604275
- Testing
- Sucrase
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- University of Miami
Short Bowel Syndrome
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive…
- Trial name
- NCT01952080
- Testing
- teduglutide
- Where
- 19 sites in United States, United Kingdom
- Volunteers
- 42 people
- Sponsor
- Shire