Clinical trials: Intestinal Failure, open to volunteers
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
Intestinal Failure
Spectral Lighting and Metabolism
The goal of this exploratory n-of-1-study is to compare markers of metabolism in infants in a Level IV Neonatal Intensive Care Unit (NICU) between two lighting environments.
- Trial name
- NCT06094504
- Testing
- Spectral Lighting
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Choline Deficiency, Liver Injury
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
TARA-001-301 is a Phase 2b/3 randomized Open-Label Dose-Selection study with an Open-Label Extension and randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to investigate the safety and efficacy of…
- Trial name
- THRIVE-3 (NCT06910943)
- Testing
- Choline Chloride for Injection
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 129 people
- Sponsor
- Protara Therapeutics
Short Bowel Syndrome
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome
- Trial name
- NCT05535361
- Testing
- Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Eclipse Regenesis, Inc.
Intestinal Failure, Low Muscle Mass
Effects of Whey Protein and Resistance Training on Muscle Mass in Patients With Intestinal Failure
This single-center, prospective, four-arm randomized controlled trial will enroll 72 adults with chronic intestinal failure and low muscle mass.
- Trial name
- NCT07759271
- Testing
- Whey Protein Supplementation Group, Resistance Training Group
- Volunteers
- 72 people
- Sponsor
- Wang Xinying
Short Bowel Syndrome (SBS), SBS Associated With Intestinal Failure (SBS-IF)
A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)
This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24…
- Trial name
- STARS-2 (NCT07742735)
- Testing
- Apraglutide
- Where
- 94 sites in United States, Argentina and 20 more
- Volunteers
- 124 people
- Sponsor
- VectivBio AG
Intestinal Failure, Short Bowel Syndrome
Resting Energy Expenditure by Gastrointestinal Functional Status
This prospective, comparative interventional study will evaluate resting energy expenditure in adults with different gastrointestinal functional status.
- Trial name
- NCT07714499
- Testing
- Protocol-Defined Metabolic and Body Composition Assessment
- Where
- Slovenia
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Institute of Oncology Ljubljana
Intestinal Failure, Parenteral Nutrition
Weaning is Winning? (WeWin Study)
We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).
- Trial name
- NCT06525753
- Testing
- Weaning off Parenteral Nutrition
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- The Hospital for Sick Children
Pediatric Intestinal Failure
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children…
- Trial name
- NCT05879835
- Testing
- KiteLock 4% Sterile Catheter Lock Solution, Heparin Lock Solution
- Where
- 8 sites in United States
- Volunteers
- 124 people
- Sponsor
- SterileCare Inc.
Pediatric Intestinal Failure
Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure
This study proposes to quantify and describe the quality of life of children with intestinal failure, and to identify the medical and socio-economic factors that impact this quality of life, using data from multiple…
- Trial name
- NCT04629014
- Where
- 14 sites in United States, Canada
- Volunteers
- 750 people
- Sponsor
- Boston Children's Hospital
Intestinal Failure
The LIFT-ECHO Last Mile Project
This is a multi-site research study to evaluate the efficacy and effectiveness of the LIFT-ECHO program to improve clinical outcomes in patients and improve patient reported quality of life (PRQOL).
- Trial name
- NCT07094308
- Testing
- Learn Intestinal Failure Tele-ECHO Program, Standard of Care
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Chronic Intestinal Failure, Intestinal Failure
Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients
The purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients.
- Conditions
- Chronic Intestinal Failure, Intestinal Failure, Home Parenteral Nutrition
- Trial name
- NCT07422792
- Testing
- Intravenous Amino Acids
- Where
- Slovenia
- Volunteers
- 40 people
- Sponsor
- Institute of Oncology Ljubljana
Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment
Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients
The purpose of this prospective observational clinical cohort study is to develop a scientifically based approach to the prediction and early diagnosis of intestinal dysfunction in cardiac surgery patients.
- Conditions
- Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment, Cardiac Surgery, Cardiac Surgery in Adult Patient
- Trial name
- PREDICT-GICS (NCT07422246)
- Testing
- additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Petrovsky National Research Centre of Surgery
Intestinal Failure
AI-driven Total Parenteral Nutrition Platform
This study tests whether an artificial intelligence (AI) tool can help doctors order total parenteral nutrition (TPN) for babies in the neonatal intensive care unit (NICU).
- Trial name
- NCT07414576
- Testing
- AI-driven total parenteral nutrition (TPN)
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Takeoff41, Inc.
Short Bowel Syndrome, Intestinal Failure
Effect of Parenteral Support on FibroScan in Short Bowel Syndrome
Home Parenteral Support (HPS) is a life-sustaining treatment for patients with short bowel syndrome and intestinal failure. This study aims to investigate how administration of parenteral support affects FibroScan results in…
- Conditions
- Short Bowel Syndrome, Intestinal Failure, Liver Diseases
- Trial name
- NCT07206004
- Testing
- Fibroscan
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Hepatic Disorders, Intestinal Failure-associated Liver Disease
VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients
The goal of this observational (diagnostic validation) study is to validate imaging-based biomarkers for assessing liver involvement in pediatric patients with established or suspected liver disease.
- Conditions
- Hepatic Disorders, Intestinal Failure-associated Liver Disease, Cystic Fibrosis Liver Disease, MAFLD
- Trial name
- VALiBi-PED (NCT07202910)
- Where
- Sweden
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Sahlgrenska University Hospital
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Liver Dysfunction, Thyroid
DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice
Background: Clinical trials often include patients from large hospitals or university clinics. Information on patients cared for at offices from statutory health insurance-accredited physicians represent evidence gaps.
- Conditions
- Liver Dysfunction, Thyroid, Atherosclerosis, Heart Failure
- Trial name
- EMANCIPATE (NCT06178302)
- Volunteers
- 1,000 people
- Sponsor
- Imed19
Intestinal Failure Associated Liver Disease
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated…
- Trial name
- NCT05919680
- Testing
- NST-6179 Part A, NST-6179 Part B
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- NorthSea Therapeutics B.V.
Growth Failure, Intestinal Infection
MAL-ED Metabolic: A Follow-Up of Chronic Disease at Puberty
The concept that the roots of cardiometabolic disease start in early life was established by Dr. David Barker, who documented relationships between low birthweight (as a marker for challenges during gestation) and later…
- Conditions
- Growth Failure, Intestinal Infection, Metabolic Syndrome, Glucose Intolerance
- Trial name
- NCT05121935
- Volunteers
- 254 people
- Sponsor
- University of Virginia