Oxidative Stress Clinical Trial
Official title:
The Impact of Human-derived Human Milk Fortifiers (H2MF) on Gut Microbiota Development and Oxidative Stress in Premature Infants
NCT number | NCT03214822 |
Other study ID # | H2MF Study |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2017 |
Est. completion date | July 30, 2019 |
Verified date | September 2019 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Days |
Eligibility |
Inclusion Criteria: - Male or female infant with birth weight <1250 grams - Gestational age between 26+0 to 30+0 weeks at birth - Able to adhere to feeding protocol - Parenteral nutrition must be started by day of life 2 - Enteral feeding >80 ml/kg/d should be reached by day of life 14 - Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations. - In the investigator's opinion, the subject's parent(s)/legal guardian(s) understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned. Exclusion Criteria: - Gestational age > 30+0 weeks at birth (to guarantee a minimum of 3 weeks H2MF treatment, since fortification ends at 33+0 AGA) - Gestational age < 26+0 weeks at birth (to minimize baseline heterogeneity, since gestational age influences gut microbiota) - Received antibiotics on the first day of specimen collection (to minimize baseline heterogeneity, since antibiotics influence gut microbiota) Note: all infants are expected to receive up to 48 hr antibiotic prophylaxis at birth according to standard NICU protocol; this criterion will exclude infants receiving extended courses of antibiotics. - Received probiotics at any time (to minimize baseline heterogeneity, since probiotics influence gut microbiota) - Unlikely to survive the study period - Presence of clinically significant congenital heart disease or other major congenital malformation - Presence prior to enrollment of intestinal perforation or stage 2 necrotizing enterocolitis (NEC) prior to tolerating fortified feeds |
Country | Name | City | State |
---|---|---|---|
Canada | Health Sciences Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Children's Hospital Foundation, Manitoba Developmental Origins of Chronic Diseases in Children Network (DEVOTION), Prolacta Bioscience |
Canada,
Azad MB, Konya T, Maughan H, Guttman DS, Field CJ, Chari RS, Sears MR, Becker AB, Scott JA, Kozyrskyj AL; CHILD Study Investigators. Gut microbiota of healthy Canadian infants: profiles by mode of delivery and infant diet at 4 months. CMAJ. 2013 Mar 19;185(5):385-94. doi: 10.1503/cmaj.121189. Epub 2013 Feb 11. — View Citation
Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, Dudell G, Rechtman DJ, Lee ML, Lucas A, Abrams S. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20. — View Citation
Flora SJ. Role of free radicals and antioxidants in health and disease. Cell Mol Biol (Noisy-le-grand). 2007 Apr 15;53(1):1-2. — View Citation
Friel JK, Diehl-Jones B, Cockell KA, Chiu A, Rabanni R, Davies SS, Roberts LJ 2nd. Evidence of oxidative stress in relation to feeding type during early life in premature infants. Pediatr Res. 2011 Feb;69(2):160-4. doi: 10.1203/PDR.0b013e3182042a07. — View Citation
Goulet O. Potential role of the intestinal microbiota in programming health and disease. Nutr Rev. 2015 Aug;73 Suppl 1:32-40. doi: 10.1093/nutrit/nuv039. Review. — View Citation
Perrone S, Tataranno ML, Santacroce A, Negro S, Buonocore G. The role of oxidative stress on necrotizing enterocolitis in very low birth weight infants. Curr Pediatr Rev. 2014;10(3):202-7. Review. — View Citation
Sullivan S, Schanler RJ, Kim JH, Patel AL, Trawöger R, Kiechl-Kohlendorfer U, Chan GM, Blanco CL, Abrams S, Cotten CM, Laroia N, Ehrenkranz RA, Dudell G, Cristofalo EA, Meier P, Lee ML, Rechtman DJ, Lucas A. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010 Apr;156(4):562-7.e1. doi: 10.1016/j.jpeds.2009.10.040. Epub 2009 Dec 29. — View Citation
Torrazza RM, Ukhanova M, Wang X, Sharma R, Hudak ML, Neu J, Mai V. Intestinal microbial ecology and environmental factors affecting necrotizing enterocolitis. PLoS One. 2013 Dec 30;8(12):e83304. doi: 10.1371/journal.pone.0083304. eCollection 2013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fecal microbiome composition at end of intervention | Relative abundance of operational taxonomic units (OTUs) determined by 16S rRNA Illumina sequencing | 33+0 weeks adjusted gestational age (end of intervention) | |
Primary | Fecal microbiome diversity at end of intervention | Shannon diversity index of microbiota, determined by 16S rRNA Illumina sequencing | 33+0 weeks adjusted gestational age (end of intervention) | |
Primary | Fecal microbiome community structure at end of intervention | Principal coordinate analysis using UniFrac distance matrices based on 16S rRNA Illumina sequencing | 33+0 weeks adjusted gestational age (end of intervention) | |
Secondary | Fecal microbiome at 1 week after intervention begins | Fecal microbiome composition, diversity and community structure from 16S rRNA Illumina Sequencing. | Study day 7 (1 week after intervention begins) | |
Secondary | Fecal microbiome at 2 weeks after intervention ends | Fecal microbiome composition, diversity and community structure from 16S rRNA Illumina Sequencing. | 35+0 weeks adjusted gestational age (2 weeks after intervention ends) | |
Secondary | Oxidative stress (urinary biomarkers) at end of intervention | F2-isoprostanes, 8-hydroxy deoxyguanine, and visfatin measured in urine. | 33+0 weeks adjusted gestational age (end of intervention) | |
Secondary | Oxidative stress (fecal calprotectin) at end of intervention | Calprotectin measured in feces | 33+0 weeks adjusted gestational age (end of intervention) | |
Secondary | Oxidative stress at 1 week after intervention begins | Fecal and urinary biomarkers of oxidative stress (fecal calprotectin, urinary F2-isoprostanes, urinary 8-hydroxy deoxyguanine, urinary visfatin). | Study day 7 (1 week after intervention begins) | |
Secondary | Oxidative stress at 2 weeks after intervention ends | Fecal and urinary biomarkers of oxidative stress (fecal calprotectin, urinary F2-isoprostanes, urinary 8-hydroxy deoxyguanine, urinary visfatin). | 35+0 weeks adjusted gestational age (2 weeks after intervention ends) |
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