Clinical trials: GI Tract Disorders
Traumatic Brain Injury
Long-term Recovery and Microbiota-Gut-Brain Axis Disruption After Traumatic Brain Injury
The OVERCOME-TBI project aims to collect multimodal data approximately 1-4 and 11-14 years after an earlier well-documented traumatic brain injury (TBI) and examine factors that influence disease progression in order to gain new…
- Trial name
- OVERCOME-TBI (NCT06927063)
- Testing
- blood-based protein biomarker assessments, blood-based metabolomic/lipidomic biomarker assessments, Diffusion-weighted magnetic resonance imaging (brain)
- Volunteers
- 160 people
- Sponsor
- Turku University Hospital
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Amniotic Fluid & the Preterm Gut
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations.
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset
- Trial name
- AMFIBIE (NCT07152106)
- Where
- 2 sites in Netherlands
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Diabetes Mellitus, Diabetes Mellitus, Type 2
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
- Trial name
- NCT04213651
- Testing
- No intervention
- Where
- United States
- Sponsor
- ProgenaBiome
Very Low Birth Weight Baby, Premature Birth
Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants
This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and urinary biomarkers of oxidative stress in…
- Conditions
- Very Low Birth Weight Baby, Premature Birth, Microbial Colonization, Oxidative Stress
- Trial name
- NCT03214822
- Testing
- H2MF
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
Colic, Infantile, Probiotic
NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants
Infant colics represent a clinical condition in childhood, characterized by an uncontrollable crying that occurs without any apparent organic cause.1 They can be associated with face redness, closed fists, thighs flexion…
- Conditions
- Colic, Infantile, Probiotic, Gut Microbiome, Bifidobacterium Breve
- Trial name
- NEOBIFI (NCT03219931)
- Testing
- Bifidobacterium breve BR03 and Bifidobacterium breve B632
- Where
- Italy
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
Microbial Colonization, Gut Microbiota
Diet Supplementation With Prebiotics to Improve Gut Health in Egyptian Children
The study described herein seeks to assess the extent to which diet supplementation of young Egyptian children, one of the most vulnerable groups to the risk of diarrhea, with prebiotic fiber can improve their gut health.
- Trial name
- NCT06561724
- Testing
- Biscuits maltodextrin, Biscuits includes prebiotics tartoufa inulin, Biscuits includes prebiotics chicory inulin
- Where
- Egypt
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- National Research Centre, Egypt
Cystic Fibrosis
Gut Imaging for Function & Transit in CF - GIFT-CF 3
An observational study of patients with cystic fibrosis (CF) starting treatment with Kaftrio (Elexacaftor / Tezacaftor / Ivacaftor) as part of routine clinical care, following EMA licensing (approved end of Aug 2020).
- Trial name
- GIFT-CF3 (NCT04618185)
- Testing
- Magnetic Resonance Imaging (MRI)
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- Nottingham University Hospitals NHS Trust
Influenza
The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine
This is a single-center, randomized, open-label trial designed to explore the interaction between mucosal microbiota colonization in the nasal cavity and gut and the immune response to an intranasal live attenuated influenza…
- Trial name
- NCT06609811
- Testing
- Intranasal Influenza Live Attenuated Vaccine
- Where
- China
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Overweight and Obesity
Effect of Diet Supplementation With Amaranth Protein on Mexican Children With Overweight and Obesity
The state of San Luis Potosí comprises several municipalities with diverse environmental conditions, ranging from semi-tropical to very arid zones. Arid zones have a high rate of childhood with obesity.
- Trial name
- AmProtObes (NCT07583043)
- Testing
- AmProt (amaranth protein isolate)
- Where
- Mexico
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Instituto Potosino De Investigacion Cientifica Y Tecnologica AC
Cognitive Performance, Inflammation
Peanut Consumption on Cognitive, Weight, and Inflammation
A multi-school, two-arm parallel cluster-randomized controlled trial will be conducted in 200 healthy young adolescents from Barcelona (Spain) to evaluate the effect of peanut consumption on cognitive performance, weight…
- Conditions
- Cognitive Performance, Inflammation, Weight Change, Body, Adolescents
- Trial name
- PEANUTY (NCT06127511)
- Testing
- Food (peanut)
- Where
- Spain
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- University of Barcelona
Autism Spectrum Disorder
Intestinal Microbiota, Tryptophan and Autism
Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation.
- Trial name
- MTA (NCT03751930)
- Testing
- Samples
- Where
- 2 sites in France
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- University Hospital, Tours
Obesity
Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern
Obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide.
- Trial name
- NCT05459675
- Testing
- Very low-calorie diet, Bariatric surgery
- Where
- Thailand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mahidol University
T-cell Lymphoma, NK-Cell Lymphoma
A Registry for People With T-cell Lymphoma
The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma.
- Conditions
- T-cell Lymphoma, NK-Cell Lymphoma, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocytic Leukemia
- Trial name
- NCT05978141
- Testing
- Optional Blood Sample and Nail Sample
- Where
- 26 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Childhood Obesity
Effect of Polysaccharide-based Complex Administration on the Gut Microbiome and Cardio-Metabolic Profile in Children With Obesity and Metabolic Syndrome.
Childhood obesity is a growing public health concern and is associated with long-term health issues. Changing lifestyle habits, especially improving diet and maintaining these changes over time, can be challenging for children…
- Trial name
- Polymets (NCT07321184)
- Testing
- Polysaccharide-based complex
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- University of Milan
Epilepsy
The Role of Gut Microbiota in Children With Epilepsy Following Ketogenic Diet
The role of human microbiota in neurological disorders via the "microbiota-gut-brain axis" is recently gaining increased attention due to the knowledge that gut microorganisms are involved in multiple gut and brain functions and…
- Trial name
- NCT05898438
- Where
- Greece
- Volunteers
- 20 people
- Sponsor
- Attikon Hospital
NEC - Necrotizing Enterocolitis, NEC
Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants.
- Conditions
- NEC - Necrotizing Enterocolitis, NEC, Preterm Babies, Preterm Infant Health
- Trial name
- MAGPIE-2 (NCT07191678)
- Where
- United Kingdom
- Volunteers
- 270 people
- Sponsor
- Imperial College Healthcare NHS Trust
Primary Sclerosing Cholangitis, Autoimmune Hepatitis
"Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"
Based upon the possible implication of microbiota and abnormal microbial metabolites such as altered bile acids, in the pathogenesis of PSC, emerging data suggests that oral antibiotics, such as vancomycin and metronidazole, may…
- Conditions
- Primary Sclerosing Cholangitis, Autoimmune Hepatitis, Overlap Syndrome
- Trial name
- NCT03069976
- Testing
- Metronidazole
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Obesity, Childhood, Metabolic Syndrome
Gut Microbiome and Obesity
Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases.
- Trial name
- MATOMS (NCT04451148)
- Testing
- Obese with or without metabolic syndromesubjects
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- Federico II University
Infant Colic, Gut Microbiota
Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics
The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal…
- Trial name
- DISIC (NCT07017244)
- Testing
- Verum, Active comparator
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Healthy, Metabolism
Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.
This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in…
- Conditions
- Healthy, Metabolism, Microbiome
- Trial name
- NCT05738460
- Testing
- antibiotics
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Zhujiang Hospital