Clinical trials: Short Gut Syndrome
Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
- Conditions
- Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome
- Trial name
- EAGLE (NCT02953223)
- Testing
- Free amino acid infant formula
- Where
- 29 sites in United States
- Volunteers
- 144 people
- Sponsor
- Société des Produits Nestlé (SPN)
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
SBS - Short Bowel Syndrome
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE 203799 in 8 patients with SBS. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 once weekly for 4 consecutive weeks…
- Trial name
- NCT03408132
- Testing
- FE203799
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- GlyPharma Therapeutics
Short Bowel Syndrome
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support.
- Trial name
- NCT02980666
- Testing
- Teduglutide
- Where
- 5 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Shire
Short Bowel Syndrome
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
- Trial name
- NCT00081458
- Testing
- Teduglutide 0.05 mg/kg/d, Teduglutide 0.1 mg/kg/d
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 84 people
- Sponsor
- Shire
Healthy
Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval).
- Trial name
- NCT01028924
- Testing
- Teduglutide
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Nycomed
Metabolic Syndrome
Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.
The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC.
- Trial name
- NCT06183801
- Testing
- Probiotics 1, Probiotics 2, Probiotics 3
- Where
- Taiwan
- Volunteers
- 82 people
- Sponsor
- Glac Biotech Co., Ltd
Short Bowel Syndrome
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.
- Trial name
- EASE SBS 5 (NCT07197944)
- Testing
- Glepaglutide
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 90 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome, Malabsorption Syndromes
Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)
A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC)…
- Conditions
- Short Bowel Syndrome, Malabsorption Syndromes, Short Gut Syndrome, Post-Op Complication
- Trial name
- CRO-SBS-IF (NCT06904872)
- Testing
- Crofelemer Powder for Oral Solution
- Where
- 8 sites in Germany, Italy
- Volunteers
- 18 people
- Sponsor
- Napo Therapeutics, S.p.A.
Short Bowel Syndrome
A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease
The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).
- Trial name
- NCT04877431
- Where
- Argentina
- Volunteers
- 45 people
- Sponsor
- Takeda
Enteric Hyperoxaluria
Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome.
- Trial name
- NCT05377112
- Testing
- SYNB8802v1
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Synlogic
Short Bowel Syndrome
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
- Trial name
- EASE SBS 2 (NCT03905707)
- Testing
- glepaglutide
- Where
- 27 sites in United States, Belgium and 7 more
- Volunteers
- 150 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome
A Phase 2 Trial Testing ZP1848 in Patients With SBS
A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
- Trial name
- glepaglutide (NCT02690025)
- Testing
- ZP1848
- Where
- Denmark
- Volunteers
- 18 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome, Short Gut Syndrome
A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the symptoms of Short Bowel Syndrome and reduce the…
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Bowel
- Trial name
- NCT02242656
- Testing
- Opium Tincture USP Deodorized
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
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
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS).
- Trial name
- EASE SBS 4 (NCT04991311)
- Testing
- Glepaglutide
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
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
Short Bowel Syndrome, Short Gut Syndrome
A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
MP-101 will be evaluated in this study to see if it is safe and tolerable.
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Gut
- Trial name
- NCT02246816
- Testing
- 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
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
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral…
- Trial name
- NCT06973304
- Testing
- Teduglutide
- Where
- 4 sites in China
- Volunteers
- 13 people
- Sponsor
- Takeda