Clinical trials: Gastrointestinal Tolerance, open to volunteers
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Gastrointestinal Tolerance, Gastrointestinal Symptoms
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life
- Trial name
- MESK-2 (NCT07342972)
- Testing
- Goat milk-based infant formula, Cow's milk-based infant formula
- Where
- Saudi Arabia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Ovarian Neoplasms, Peritoneal Neoplasms
Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer
The purpose of this study is to evaluate the tolerance, safety, efficacy, and pharmacokinetics of pressurized intraperitoneal aerosol chemotherapy (PIPAC) with paclitaxel in patients with platinum-resistant recurrent ovarian…
- Trial name
- NCT07273396
- Testing
- Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel
- Volunteers
- 53 people
- Sponsor
- Seoul National University Hospital
Refeeding Syndrome, Malnutrition
Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome
Introduction: Refeeding syndrome (RS) is a life-threatening metabolic complication of nutritional support. Prolonged fasting, frequently observed in malnourished patients referred for percutaneous endoscopic gastrostomy (PEG)…
- Trial name
- NCT07674589
- Where
- Portugal
- Volunteers
- 15 people
- Sponsor
- Hospital Garcia de Orta
Lactose Intolerance, Adult Type, Intestinal Permability
Lactose Intolerance and Intestinal Permability
"This study evaluates the interplay between lactose intolerance, intestinal barrier function (zonulin), and intestinal inflammation (fecal calprotectin) in adults, aiming to clarify their independent contributions to symptom…
- Conditions
- Lactose Intolerance, Adult Type, Intestinal Permability, IBS (Irritable Bowel Syndrome)
- Trial name
- LI (NCT07424898)
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people
- Sponsor
- Bezmialem Vakif University
Non-Alcoholic Fatty Liver Disease
Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
This clinical trial aims to investigate the effects of TOTUM-448, a mix of 5 plant extracts and choline, consumed at the daily regimen of two times per day, on liver fat content, cardiometabolic risk factors and gut microbiota…
- Trial name
- CARDIO-LIVER (NCT06704321)
- Testing
- TOTUM-448
- Where
- Canada
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Valbiotis
Acute Pancreatitis (AP), Enhancing Enteral Nutrition Tolerance
Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis
The goal of this study is to learn if Relizorb, a fat-digesting enzyme, can improve tolerance of tube feeds in adult patients with moderate to severe pancreatitis.
- Trial name
- NCT07583342
- Testing
- RELiZORB digestive enzyme (immobilized lipase) cartridge
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Northwell Health
Gastroparesis, Shock
Gastric Emptying and Enteral Nutrition Tolerance According to Vasopressor Dose in ICU Patients
This study investigates whether the dose of vasopressor medications (drugs that maintain blood pressure in shock) affects gastric emptying during tube feeding in the intensive care unit (ICU).
- Conditions
- Gastroparesis, Shock, Critical Illness, Gastric Emptying
- Trial name
- NCT07802379
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
Chronic Hepatitis B
Targeting ANKRD11 Reverses HBV-Specific CD8+ T Cell Dysfunction and Tolerance
Achieving a functional cure for chronic hepatitis B (CHB) is largely hindered by the irreversible functional exhaustion and immune tolerance of hepatitis B virus (HBV)-specific CD8 positive T (CD8+ T) cells.
- Trial name
- NCT07777250
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Beijing Municipal Administration of Hospitals
Critical Illness, Gastro Intestinal Surgery
Undiluted and Diluted Nutrition
Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial. Each patient will be fed via the gastrointestinal tract.
- Conditions
- Critical Illness, Gastro Intestinal Surgery, Enteral Feeding Intolerance, Gastro-Intestinal Disorder
- Trial name
- NCT07352150
- Testing
- Enteral fluid, Intravenous fluid
- Where
- 2 sites in Poland
- Volunteers
- 80 people
- Sponsor
- John Paul II Catholic University of Lublin
Traumatic Brain Injury, Neurocritical Care
Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.
Study Objective This clinical trial primarily aims to investigate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI) and to evaluate its impact…
- Conditions
- Traumatic Brain Injury, Neurocritical Care, Enteral Feeding Intolerance
- Trial name
- SEMINAR (NCT07092423)
- Testing
- Semi-elemental formula, Standard formula
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tang-Du Hospital
Liver Failure
TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation
The unmet medical need in solid organ transplantation is to eliminate the lifelong requirement of powerful immune suppression drug combinations with their attendant side effects, and to prevent immune mediated rejection of the…
- Trial name
- TEMPO-LT (NCT07634562)
- Testing
- Anti-Thymocyte Globulin, ATG (Rabbit), Total lymphoid irradiation
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Colorectal Cancer, Gastro Esophageal Junctional Cancer
IKS04 Regimen in Advanced Solid Tumors That Express CA242
This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further…
- Conditions
- Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma
- Trial name
- NCT07738939
- Testing
- IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Iksuda Therapeutics Ltd.
Liver Fat, Liver Fibrosis
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease…
- Conditions
- Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes
- Trial name
- Ertu-NASH (NCT05644717)
- Testing
- Ertugliflozin 5 mg, 15mg
- Where
- Pakistan
- Volunteers
- 164 people
- Sponsor
- Getz Pharma
Paediatric
Vegetarian Tube Feed Study
This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.
- Trial name
- Tube feed (NCT07378111)
- Testing
- paediatric tube feed
- Volunteers
- 25 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cystic Fibrosis-related Diabetes, Cystic Fibrosis
Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis
Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes.
- Trial name
- NCT06560463
- Testing
- Access to Dexcom G7 CGM Data
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Medical College of Wisconsin
Gastrointestinal Disease, Inflammatory Bowel Disease (IBD)
Elemental 028 Extra Case Studies
Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to…
- Conditions
- Gastrointestinal Disease, Inflammatory Bowel Disease (IBD), Short Bowel, Malabsorption
- Trial name
- E028E (NCT06877923)
- Testing
- Elemental 028 Extra
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
Necrotizing Enterocolitis, Death
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely…
- Conditions
- Necrotizing Enterocolitis, Death, Sepsis Newborn, Feeding Disorder Neonatal
- Trial name
- PEPS (NCT05604846)
- Testing
- ProPrems
- Where
- Sweden
- Volunteers
- 1,600 people
- Sponsor
- Region Stockholm
Breast Cancer, Gastric Cancer
IKS014 in Advanced Solid Tumors That Express HER2
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate…
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal-junction Cancer
- Trial name
- NCT05872295
- Testing
- IKS014
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 165 people
- Sponsor
- Iksuda Therapeutics Ltd.
Gastrointestinal Cancer
Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer
The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastrointestinal cancer in adults.
- Trial name
- NCT07329894
- Testing
- XH001 injection, Tumor vaccine-induced specific T-cell injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Beijing GoBroad Hospital