Clinical trials: Gastro-Intestinal Tolerance, open to volunteers
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
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
Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Neuroendocrine Tumor (NET)
Nutrition Intervention for Pancreatic Cancer
Patients with pancreatic cancer (pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumor (NET)) commonly experience fat malabsorption due to exocrine pancreatic insufficiency (EPI) and leads to…
- Trial name
- NCT07554560
- Testing
- Structured Lipid Medical Food
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Children's Hospital of Philadelphia
Short Gut Syndrome
Fiber Food Introduction in Pediatric 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
- NCT05432648
- Testing
- Green bean puree
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
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.
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.
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
Crohn Disease (CD)
Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study. Its design is supported by the following elements: The results of the ADICROHN pilot study (EudraCT No.
- Trial name
- ADICROHN3 (NCT07629245)
- Testing
- injection of thawed SVF
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Cervical Cancer, Anal Cancer
CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers
A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A*02:01+ Subjects HPV16 positive advanced cervical, anal, or…
- Conditions
- Cervical Cancer, Anal Cancer, Head and Neck Cancers, Other Solid Tumors
- Trial name
- NCT06358053
- Testing
- CRTE7A2-01 TCR-T cell therapy
- Volunteers
- 24 people
- Sponsor
- Corregene Biotechnology Co., Ltd
Neurogenic Bowel, Spinal Cord Injuries (SCI)
Transcutaneous Spinal Cord Stimulation for Bowel Management in Individuals with Motor Complete Spinal Cord Injury
The primary goals of this pilot trial are to understand the feasibility and safety of thoracolumbar transcutaneous spinal cord stimulation for neurogenic bowel management in individuals with new onset, traumatic, cervicothoracic…
- Trial name
- NCT06801431
- Testing
- Transcutaneous spinal cord stimulation
- Volunteers
- 5 people
- Sponsor
- Nova Scotia Health Authority
Critical Illness, Surgery
Diluted and Undiluted Enteral 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, Surgery, Enteral Feeding Intolerance, Gastro-Intestinal Disorder
- Trial name
- NCT06516835
- Testing
- Enteral fluid, Intravenous fluid
- Where
- 5 sites in Poland
- Volunteers
- 60 people
- Sponsor
- Medical University of Lublin
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
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
Colon Cancer Adenocarcinoma
A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer
This study is a phase Ib/II study to evaluate the efficacy, safety and tolerance of HLX43 combined with HLX07 or Serplulimab in patients with advanced or metastatic colorectal cancer failed or intolerance to standard first-line…
- Trial name
- NCT07358585
- Testing
- HLX43 dose 1 + HLX07, HLX43 dose 2 + HLX07, HLX43 dose 3 + Serplulimab
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Shanghai Henlius Biotech
Milk Intolerance, Milk Hypersensitivity
Goat vs. Cow Milk Digestive Tolerance
The objective of this study is to assess to what extent goat's milk is better tolerated than cow's milk among individuals who report being intolerant to cow's milk, and, if so, to understand the underlying factors.
- Conditions
- Milk Intolerance, Milk Hypersensitivity, Cow Milk Protein Sensitivity
- Trial name
- DIGIGOAT (NCT07239856)
- Testing
- Cow milk, Goat Milk
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Cerebral Palsy (CP), Oncology
Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.
- Trial name
- Blends (NCT07341464)
- Testing
- Tube feed
- Where
- 2 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Société des Produits Nestlé (SPN)
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
Breast Cancer, Lung Cancer (Non-Small Cell)
Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer
This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast…
- Conditions
- Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal Cancer, Physical Activity
- Trial name
- PREDU (NCT07502963)
- Testing
- PREDU Exercise Program, Recommendation Exercise Program
- Where
- 3 sites in Spain
- Volunteers
- 70 people
- Sponsor
- University of Vic - Central University of Catalonia
Post Bariatricsurgery, Hypoglycemia
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss.
- Trial name
- NCT00992901
- Testing
- Exendin-(9-39), Atropine, GLP-1 and GIP
- Where
- 2 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
Gastroesophageal Reflux in Children
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
- Trial name
- STELLAR (NCT04358146)
- Testing
- Experimental Infant formula, Infant formula thickened with locust bean gum
- Where
- 12 sites in Belgium, France and 2 more
- Volunteers
- 346 people
- Sponsor
- United Pharmaceuticals