Clinical trials: Gastrointestinal Tract
- Condition Gastrointestinal Tract
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Diphtheria, Tetanus
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT04073459
- Testing
- DTwP-HepB-Sabin IPV-Hib, Pentavalent vaccine and Salk IPV
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- LG Chem
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Cystic Fibrosis
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P.
- Trial name
- NCT03905642
- Testing
- Arikayce™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 49 people
- Sponsor
- Insmed Incorporated
Viral Hepatitis Vaccines, Hepatitis A
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.
- Conditions
- Viral Hepatitis Vaccines, Hepatitis A, Cytomegalovirus, Varicella-Zoster Virus
- Trial name
- NCT01160081
- Testing
- Serum sample
- Where
- Mexico
- Volunteers
- 3,658 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Cystic Fibrosis
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109…
- Trial name
- NCT02544451
- Testing
- LUM/IVA
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 246 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy Young Adults
Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™
The purpose of this study is to evaluate changes in self-reported wellbeing outcomes in adolescents. Bifidobacterium longum, 1714™ has previously been associated with beneficial effects on stress-related outcomes, sleep quality…
- Trial name
- NCT07752342
- Testing
- Bifidobacterium longum, 1714™
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Novonesis
Cystic Fibrosis
Mannitol Dose Response Study in Cystic Fibrosis
Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology…
- Trial name
- NCT00251056
- Testing
- mannitol
- Where
- 12 sites in Argentina, Canada
- Volunteers
- 48 people
- Sponsor
- Syntara
Cystic Fibrosis
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
- Trial name
- NCT00103714
- Testing
- denufosol tetrasodium (INS37217)
- Volunteers
- 72 people
- Sponsor
- Merck Sharp & Dohme LLC
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the…
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Trial name
- NCT01427712
- Testing
- Pancrelipase
- Where
- 21 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Mylan Inc.
Gut Microbiota
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
A multi-centre, randomized, parallel-group, double-blind, controlled, exploratory clinical trial is conducted to assess the positive effect of feeding a formula containing synbiotics (pre- and probiotics) on the composition of…
- Trial name
- GOLF-CS (NCT04991792)
- Testing
- Intervention Group 1: Infant Formula with synbiotics, Intervention Group 2: Infant Formula with prebiotics, Control Group 1 and 2: Infant Formula without synbiotics
- Where
- Bulgaria
- Volunteers
- 486 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Digestive System Diseases, Pancreatic Disease
Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients <= 2 years of age.
- Conditions
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Trial name
- NCT00663975
- Testing
- DCI 1020
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Digestive Care, Inc.
Cystic Fibrosis
Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.
- Trial name
- NCT00060801
- Testing
- BIIL 283 BS (Amelubent)
- Where
- 35 sites in United States
- Volunteers
- 420 people
- Sponsor
- Boehringer Ingelheim
Intestinal Growth of Young Children
A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children
The aim of the study is to examine the intervening effects of N1115 Probiotic Supplement (containing Junlebao Lp. N1115) on gut development in young children at the age of 6 month to 3 years by the way of a randomised…
- Trial name
- N1115Baby (NCT03416595)
- Testing
- N1115 Probiotic Supplement
- Where
- Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Junlebao Dairy Group Co., Ltd.
Cystic Fibrosis, Pancreatic Insufficiency
Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis
The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis…
- Trial name
- NCT00432861
- Testing
- PANCRECARB® (pancrelipase)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Digestive Care, Inc.
Melanoma, Solid Tumor
Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
This is a subprotocol of Master Protocol DAY101-102 and is a Phase 1b/2, multi-center, open label subprotocol of participants ≥12 years of age, with recurrent or progressive solid tumors with alterations in the key proteins of…
- Conditions
- Melanoma, Solid Tumor, Pilocytic Astrocytoma, Non Small Cell Lung Cancer
- Trial name
- NCT07121829
- Testing
- Tovorafenib, Tovorafenib Drug: Pimasertib
- Where
- 10 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Human Gut Microbiome Development
Phages Dynamics and Influences During Human Gut Microbiome Establishment
Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology.
- Trial name
- METAKIDS (NCT03296631)
- Testing
- collection of diapers with fresh stools
- Where
- 2 sites in France
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Pancreatic Insufficiency, Cystic Fibrosis
Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
- Conditions
- Pancreatic Insufficiency, Cystic Fibrosis, Digestive System Diseases, Lung Diseases
- Trial name
- NCT01710644
- Testing
- Burlulipase
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- Nordmark Arzneimittel GmbH & Co. KG