Clinical trials: Intestinal Inflammation
Severe Malnutrition, Enteritis
Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM)
Children with complicated severe acute malnutrition (SAM), such as inability to take adequate feeds, infection and diarrhoea, require in-patient management.
- Trial name
- SAM (NCT02639416)
- Testing
- Polymeric formula, Elemental formula, Standard management
- Where
- Malawi
- Volunteers
- 95 people
- Sponsor
- Liverpool School of Tropical Medicine
ASD
Evaluate the Efficacy and Safety of DHA in the Adjuvant Treatment of Children With ASD.
In the etiopathogenesis of autistic spectrum disorder (ASD) several hypotheses have been described that include inflammation, metabolic alterations, activation of oxidative stress, changes in the intestinal microbiota and in the…
- Trial name
- NCT03620097
- Testing
- EuPoly-3 DHA Infant
- Volunteers
- 60 people
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Malnutrition (Calorie), Infant Nutrition Disorder
Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed.
- Conditions
- Malnutrition (Calorie), Infant Nutrition Disorder, Growth Flatering, Gut Microbiome
- Trial name
- GMDFA (NCT07225153)
- Testing
- GMDFA, Undiluted Goat Milk
- Where
- Pakistan
- Volunteers
- 15 people
- Sponsor
- Aga Khan University
Necrotizing Enterocolitis, Sepsis
Human Milk Fortification in Extremely Preterm Infants
This is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely…
- Conditions
- Necrotizing Enterocolitis, Sepsis, Mortality
- Trial name
- N-forte (NCT03797157)
- Testing
- H2MF, Bovine milk-based fortifier
- Where
- 5 sites in Sweden
- Volunteers
- 229 people
- Sponsor
- Thomas Abrahamsson, MD, PhD
Anemia, Iron Deficiency
Iron and Prebiotics Fortification in Kenyan Infants
Iron deficiency and anemia are health issues affecting mainly infants and women in developing countries. Iron deficiency in infancy can have long-lasting impact on cognitive and motor development of the child.
- Conditions
- Anemia, Iron Deficiency, Diarrhea, Malaria
- Trial name
- Iro'n'Pre (NCT02118402)
- Testing
- Fortified maize porridge
- Where
- Kenya
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Swiss Federal Institute of Technology
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Gut Inflammation
A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children
This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed, cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to compare the effects on gut inflammation…
- Trial name
- NCT03081845
- Testing
- Oral consumption of milk A1 in study phase 1, Oral consumption of milk A2 in study phase 1, Oral consumption of milk A1 in study phase 2
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Crohn's Disease, Active, Crohn's Disease (CD)
Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease
The purpose of this study is to test the effect of an anti-inflammatory diet tailored for patients living in the United States with Crohn's Disease (CD) on clinical symptoms and disease inflammation and to identify biomarkers of…
- Conditions
- Crohn's Disease, Active, Crohn's Disease (CD), Diet Interventions
- Trial name
- NCT07671872
- Testing
- Catered Anti-Inflammatory Diet, Diet Guidance for Usual Diet
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- University of Miami
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London
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
Serious Systemic Infections, Necrotizing Enterocolitis
Metronidazole Pharmacokinetics (PK) in Premature Infants
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis.
- Trial name
- PTN_METRO (NCT01222585)
- Testing
- Metronidazole
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Michael Cohen-Wolkowiez
Cystic Fibrosis
Probiotics on Intestinal Inflammation in Cystic Fibrosis
Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and…
- Trial name
- NCT01961661
- Testing
- Lactobacillus rhamnosus GG
- Where
- Italy
- Volunteers
- 22 people
- Sponsor
- Federico II University
Inflammatory Bowel Diseases
The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)
The goal of this study is to prospectively test the hypothesis that specific dietary modification can improve patient symptoms by promoting beneficial changes in the composition of the microbiome that, in turn, alter the immune…
- Trial name
- IBD-AID (NCT04757181)
- Testing
- The IBD-AID
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Massachusetts, Worcester
Gut Microbiome, Body Composition
Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study
Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health.
- Conditions
- Gut Microbiome, Body Composition, Adherence, Metabolites
- Trial name
- MUNCHIES (NCT07309536)
- Testing
- Mediterranean Diet Nutrition Program, Standard Diet Education Program
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of New Brunswick
IBD (Inflammatory Bowel Disease), Colon Cancer
Microbiota: Its Role in Chronic Inflammation, IDB and Risk of Colorectal Cancer. Evaluation of a Predictive Prognostic Model With Therapeutic Implications
The gut microbiome is emerging as a crucial factor in several intestinal diseases, contributing to the etiopathogenesis of inflammatory disorders.
- Trial name
- NCT07106463
- Where
- Italy
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Messina
Malnourished Children
Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District
The goal of this clinical trial is to learn if intervention with channa striata extract or inbumin forte sachet as a food supplement can improve intestinal damage and nutritional status in malnourished children aged 1.5-5 years.
- Trial name
- Striatin1 (NCT06933862)
- Testing
- Striatin
- Where
- 2 sites in Indonesia
- Volunteers
- 122 people
- Sponsor
- Universitas Indonesia
Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development.
- Conditions
- Feeding Intolerance, Necrotizing Enterocolitis, Postnatal Growth, Late-Onset Neonatal Sepsis
- Trial name
- FortiColos-Ⅱ (NCT03822104)
- Testing
- Bovine Colostrum, FM85
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Per Torp Sangild