Clinical trials: Short Bowel Syndrome (SBS)
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
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
- Trial name
- STARSnutrition (NCT04964986)
- Testing
- Apraglutide
- Where
- 2 sites in Belgium, France
- Volunteers
- 10 people
- Sponsor
- VectivBio AG
Short Bowel Syndrome
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
- Trial name
- STARS (NCT04627025)
- Testing
- apraglutide
- Where
- 68 sites in United States, Argentina and 16 more
- Volunteers
- 164 people
- Sponsor
- VectivBio AG
Short Bowel Syndrome
Specific Dietary Fibers May Enhance Colonic Adaptation in Short Bowel Syndrome Through Microbial and Metabolic Mechanisms That Drive Functional Compensation.
Ten patients with short intestines in clinical practice were intervened with dietary fiber. Serum and feces before and after the dietary fiber intervention were collected, and relevant indicators of nutrition and intestinal…
- Trial name
- NCT07186608
- Testing
- Dietary fiber intervention
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Jinling Hospital, China
Short Gut Syndrome
Successful Fiber Food Introduction in Short Bowel Syndrome
Short bowel syndrome (SBS) is a rare but challenging condition in which patients have insufficient bowel length to meet fluid, electrolyte, and nutrient requirements without parenteral support.
- Trial name
- GREENBEANS (NCT06240065)
- Testing
- Green bean puree
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Short Bowel Syndrome (SBS) in Adults
Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome
This is a multicenter, open-label, single-arm clinical trial. A total of 100 participants with short bowel syndrome (SBS) receiving parenteral nutrition (PN) support are planned to be enrolled.
- Trial name
- NCT07691125
- Testing
- rhGH injection
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Nonthyroidal Illness Syndrome, Short Bowel Syndrome
Nonthyroidal Illness Syndrome in SBS
Nonthyroidal illness syndrome (NTIS) is prevalent in critical illness; it is associated with poor outcomes. However, few studies have focused on the relationship between NTIS and short bowel syndrome (SBS).
- Trial name
- NCT04450472
- Volunteers
- 51 people
- Sponsor
- Jinling Hospital, China
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
Prematurity, Intestine Perforation
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants.
- Conditions
- Prematurity, Intestine Perforation, Necrotizing Enterocolitis (NEC), Short Bowel Syndrome (SBS)
- Trial name
- EMLFO-2 (NCT01674478)
- Testing
- Microlipid with fish oil, Microlipid
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Wake Forest University
SBS - Short Bowel Syndrome
Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives
Today, patients express a very strong need to take into account the consequences of their disease and its treatments in their therapeutic follow-up.
- Trial name
- ARTEMIS_GC (NCT04150302)
- Testing
- Exploratory interviews, Semi-directive interviews, Delphi Process
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Central Hospital, Nancy, France
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
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
SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Questionnaire (SBS QoL)
Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support.
- Trial name
- SBS DISK (NCT06771505)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Hospices Civils de Lyon
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
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
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal…
- Trial name
- NCT04775706
- Testing
- HM15912 Active
- Where
- 15 sites in United States, Belgium and 6 more
- Volunteers
- 18 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
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, 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 (SBS)
TED_ORG: Study on Short Bowel Syndrome
The goal of this clinical trial is to understand why pediatric patients with short bowel syndrome respond differently to treatment with the glucagon-like peptide-2 (GLP-2) analogue teduglutide.
- Trial name
- NCT07400783
- Testing
- Teduglutide (ALX-0600), No Treatment Added
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Meyer Children's Hospital IRCCS
Short Bowel Syndrome
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
- Trial name
- NCT00172185
- Testing
- teduglutide 0.05 mg/kg/d, teduglutide 0.10 mg/kg/d
- Where
- 21 sites in United States, Belgium and 6 more
- Volunteers
- 65 people
- Sponsor
- Shire