Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
NCT ID: NCT05945017
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
233 participants
INTERVENTIONAL
2014-01-01
2027-12-31
Brief Summary
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Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Daily dose of 6x109 UFC Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) from 7 days of life until reaching a postmenstrual age of 34 weeks or discharge
Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Control
Untreated control group
No interventions assigned to this group
Interventions
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Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Eligibility Criteria
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Inclusion Criteria
* Born at BCNatal Hospital Clínic between years 2014-2019.
Exclusion Criteria
* Infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)
32 Weeks
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Principal Investigators
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Benjamin James Baucells, MD
Role: PRINCIPAL_INVESTIGATOR
Neonataology Service, BCNatal Hospital Clínic
Giorgia Sebastiani
Role: PRINCIPAL_INVESTIGATOR
Neonatology Service, BCNatal Hospital Clínic
Locations
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Neonataology Service, BCNatal Hospital Clinic Seu Maternitat
Barcelona, , Spain
Countries
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References
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Sjogren YM, Jenmalm MC, Bottcher MF, Bjorksten B, Sverremark-Ekstrom E. Altered early infant gut microbiota in children developing allergy up to 5 years of age. Clin Exp Allergy. 2009 Apr;39(4):518-26. doi: 10.1111/j.1365-2222.2008.03156.x. Epub 2009 Feb 9.
O'Reilly H, Johnson S, Ni Y, Wolke D, Marlow N. Neuropsychological Outcomes at 19 Years of Age Following Extremely Preterm Birth. Pediatrics. 2020 Feb;145(2):e20192087. doi: 10.1542/peds.2019-2087. Epub 2020 Jan 10.
Food and Agricultural Organization of the United Nations and World Health Organization. Health and nutritional properties of probiotics in food including powder milk with live lactic acid bacteria. World Health Organization, (2001).
Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243.
Mai V, Young CM, Ukhanova M, Wang X, Sun Y, Casella G, Theriaque D, Li N, Sharma R, Hudak M, Neu J. Fecal microbiota in premature infants prior to necrotizing enterocolitis. PLoS One. 2011;6(6):e20647. doi: 10.1371/journal.pone.0020647. Epub 2011 Jun 6.
Underwood MA, Sohn K. The Microbiota of the Extremely Preterm Infant. Clin Perinatol. 2017 Jun;44(2):407-427. doi: 10.1016/j.clp.2017.01.005. Epub 2017 Mar 22.
Thomas JP, Raine T, Reddy S, Belteki G. Probiotics for the prevention of necrotising enterocolitis in very low-birth-weight infants: a meta-analysis and systematic review. Acta Paediatr. 2017 Nov;106(11):1729-1741. doi: 10.1111/apa.13902. Epub 2017 Jun 9.
Baucells BJ, Mercadal Hally M, Alvarez Sanchez AT, Figueras Aloy J. [Probiotic associations in the prevention of necrotising enterocolitis and the reduction of late-onset sepsis and neonatal mortality in preterm infants under 1,500g: A systematic review]. An Pediatr (Barc). 2016 Nov;85(5):247-255. doi: 10.1016/j.anpedi.2015.07.038. Epub 2015 Nov 21. Spanish.
Bi LW, Yan BL, Yang QY, Li MM, Cui HL. Which is the best probiotic treatment strategy to prevent the necrotizing enterocolitis in premature infants: A network meta-analysis revealing the efficacy and safety. Medicine (Baltimore). 2019 Oct;98(41):e17521. doi: 10.1097/MD.0000000000017521.
van den Akker CHP, van Goudoever JB, Shamir R, Domellof M, Embleton ND, Hojsak I, Lapillonne A, Mihatsch WA, Berni Canani R, Bronsky J, Campoy C, Fewtrell MS, Fidler Mis N, Guarino A, Hulst JM, Indrio F, Kolacek S, Orel R, Vandenplas Y, Weizman Z, Szajewska H. Probiotics and Preterm Infants: A Position Paper by the European Society for Paediatric Gastroenterology Hepatology and Nutrition Committee on Nutrition and the European Society for Paediatric Gastroenterology Hepatology and Nutrition Working Group for Probiotics and Prebiotics. J Pediatr Gastroenterol Nutr. 2020 May;70(5):664-680. doi: 10.1097/MPG.0000000000002655.
Alfaleh K, Anabrees J, Bassler D, Al-Kharfi T. Probiotics for prevention of necrotizing enterocolitis in preterm infants. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD005496. doi: 10.1002/14651858.CD005496.pub3.
Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson AR. Neurologic and developmental disability after extremely preterm birth. EPICure Study Group. N Engl J Med. 2000 Aug 10;343(6):378-84. doi: 10.1056/NEJM200008103430601.
Hortensius LM, van Elburg RM, Nijboer CH, Benders MJNL, de Theije CGM. Postnatal Nutrition to Improve Brain Development in the Preterm Infant: A Systematic Review From Bench to Bedside. Front Physiol. 2019 Jul 26;10:961. doi: 10.3389/fphys.2019.00961. eCollection 2019.
Cryan JF, O'Mahony SM. The microbiome-gut-brain axis: from bowel to behavior. Neurogastroenterol Motil. 2011 Mar;23(3):187-92. doi: 10.1111/j.1365-2982.2010.01664.x.
Yang I, Corwin EJ, Brennan PA, Jordan S, Murphy JR, Dunlop A. The Infant Microbiome: Implications for Infant Health and Neurocognitive Development. Nurs Res. 2016 Jan-Feb;65(1):76-88. doi: 10.1097/NNR.0000000000000133.
Huang EJ, Reichardt LF. Neurotrophins: roles in neuronal development and function. Annu Rev Neurosci. 2001;24:677-736. doi: 10.1146/annurev.neuro.24.1.677.
Ranuh R, Athiyyah AF, Darma A, Risky VP, Riawan W, Surono IS, Sudarmo SM. Effect of the probiotic Lactobacillus plantarum IS-10506 on BDNF and 5HT stimulation: role of intestinal microbiota on the gut-brain axis. Iran J Microbiol. 2019 Apr;11(2):145-150.
Nikolaou KE, Malamitsi-Puchner A, Boutsikou T, Economou E, Boutsikou M, Puchner KP, Baka S, Hassiakos D. The varying patterns of neurotrophin changes in the perinatal period. Ann N Y Acad Sci. 2006 Dec;1092:426-33. doi: 10.1196/annals.1365.041.
Liu DY, Shen XM, Yuan FF, Guo OY, Zhong Y, Chen JG, Zhu LQ, Wu J. The Physiology of BDNF and Its Relationship with ADHD. Mol Neurobiol. 2015 Dec;52(3):1467-1476. doi: 10.1007/s12035-014-8956-6. Epub 2014 Oct 30.
Jacobs SE, Hickey L, Donath S, Opie GF, Anderson PJ, Garland SM, Cheong JLY; ProPremsStudy Groups. Probiotics, prematurity and neurodevelopment: follow-up of a randomised trial. BMJ Paediatr Open. 2017 Nov 25;1(1):e000176. doi: 10.1136/bmjpo-2017-000176. eCollection 2017.
Chou IC, Kuo HT, Chang JS, Wu SF, Chiu HY, Su BH, Lin HC. Lack of effects of oral probiotics on growth and neurodevelopmental outcomes in preterm very low birth weight infants. J Pediatr. 2010 Mar;156(3):393-6. doi: 10.1016/j.jpeds.2009.09.051. Epub 2009 Nov 14.
Romeo MG, Romeo DM, Trovato L, Oliveri S, Palermo F, Cota F, Betta P. Role of probiotics in the prevention of the enteric colonization by Candida in preterm newborns: incidence of late-onset sepsis and neurological outcome. J Perinatol. 2011 Jan;31(1):63-9. doi: 10.1038/jp.2010.57. Epub 2010 Apr 22.
Sari FN, Eras Z, Dizdar EA, Erdeve O, Oguz SS, Uras N, Dilmen U. Do oral probiotics affect growth and neurodevelopmental outcomes in very low-birth-weight preterm infants? Am J Perinatol. 2012 Sep;29(8):579-86. doi: 10.1055/s-0032-1311981. Epub 2012 May 7.
Johnson S, Hollis C, Kochhar P, Hennessy E, Wolke D, Marlow N. Psychiatric disorders in extremely preterm children: longitudinal finding at age 11 years in the EPICure study. J Am Acad Child Adolesc Psychiatry. 2010 May;49(5):453-63.e1.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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HCB/2021/0454
Identifier Type: -
Identifier Source: org_study_id
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