Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota & Oxidative

Status Completed

Clinical Trial Summary

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 premature infants.

Clinical Trial Description

While breast milk provides complete nutrition for full term infants, supplementation with human milk fortifiers (HMF) is required to achieve optimal weight gain in very low birthweight (VLBW) preterm neonates. Traditionally, HMF have been derived from bovine milk. Bovine-based infant formula has been shown to cause dysbiosis of the infant gut microbiome (Azad et al 2013) and increased oxidative stress in preterm neonates (Friel et al 2011). Microbiome dysbiosis and oxidative stress have been implicated in numerous inflammatory conditions, including both acute (eg. necrotizing enterocolitis, NEC) and long-term (eg. asthma, metabolic syndrome) sequela of preterm birth (Torrazza et al 2013, Goulet et al 2015, Flora et al 2007, Perrone et al 2014). Recent studies show that new human-derived HMF (H2MF) are superior to standard bovine HMF for nourishing VLBW preterm infants and preventing NEC (Sullivan et al 2010, Cristofalo et al 2013). However, the biological basis for these clinical benefits is unknown, which limits our ability to inform and improve feeding strategies for VLBW preterm infants. This will be the first study to evaluate the impact of H2MF on gut microbiota and oxidative stress in preterm infants.

Specific Objectives:

1. To evaluate the effect of H2MF vs. HMF on gut microbiota composition in premature infants born <1250 gr between 26 and 30 weeks of gestational age.

2. To evaluate the effect of H2MF vs. HMF on fecal and urinary biomarkers of oxidative stress in premature infants born <1250 gr between 26 and 30 weeks of gestational age. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03214822
Study type	Interventional
Source	University of Manitoba
Contact
Status	Completed
Phase	N/A
Start date	August 1, 2017
Completion date	July 30, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03255187` - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution	N/A
Completed	`NCT04136821` - The Long-term Effects of Oceanix™ on Resistance Training Adaptations	N/A
Recruiting	`NCT03790345` - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics	Phase 2/Phase 3
Completed	`NCT03358524` - Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia	Phase 4
Recruiting	`NCT05327348` - Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery	Phase 3
Completed	`NCT03288623` - The Effects of Dark Chocolate Implementation in Elite Athletes	N/A
Completed	`NCT04419025` - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease	Phase 2
Completed	`NCT04597983` - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists	N/A
Not yet recruiting	`NCT06159543` - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes	N/A
Enrolling by invitation	`NCT03030456` - Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders	N/A
Completed	`NCT02256254` - SIMOX - Induction of Oxidative Stress	Phase 2
Not yet recruiting	`NCT02202239` - Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients	Phase 4
Recruiting	`NCT02048592` - Impact of Immunonutrition on the Patients With Cystic Fibrosis	Phase 4
Completed	`NCT01942460` - Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients	Phase 4
Completed	`NCT02463318` - The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects	N/A
Completed	`NCT02177383` - Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance	N/A
Completed	`NCT01990391` - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities	N/A
Completed	`NCT00845130` - Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes	N/A
Completed	`NCT00607893` - Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea	N/A
Active, not recruiting	`NCT00247507` - The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms