Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-26 @ 7:29 PM
Study NCT ID:
NCT02197468
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study
Sponsor:
University Hospital of North Norway
Organization:
Study Overview
Official Title:
Gut Microbiome Study in Preterm Infants - a Norwegian Multi Centre Study
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINGU
Brief Summary:
Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria may contribute to the development of NEC.
Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age \<28 weeks/birth weight \<1000g).
The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.
Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.
Study hypotheses:
* Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.
* Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.
* After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.
* A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.
Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age \<28 weeks/birth weight \<1000g).
The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.
Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.
Study hypotheses:
* Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.
* Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.
* After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.
* A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.
Detailed Description:
Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). Prematurity is the most important risk factor for NEC. The pathogenesis of NEC remains unclear, and prevention and treatment strategies are limited. It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria, is significant in the pathogenesis of NEC.
Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age (GA) \<28 weeks/birth birth weight (BW) \<1000 g).
The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.
Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity and taxonomy will be analysed using bioinformatic tools
Inclusion criteria:
* Preterm infants 24-27 weeks gestation/ birth weight \< 1000 g receiving probiotics
* Preterm infants 28-31 weeks gestation/BW 1000-1500 g not receiving probiotics
* Healthy term infants
Exclusion criteria
* Preterm infants \< 24 weeks gestation
* Preterm infants \< 32 weeks with severe lethal complication/poor prognosis around 1 week of age
* Infants with severe congenital malformations
Fecal samples will be obtained:
* 1 week of age
* 4 weeks of age
* 4 months corrected age
* 12 months corrected age
Study hypotheses:
* Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.
* Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.
* After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.
* A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.
This is an explorative study. No formal sample size assessment is possible. Sequencing costs will be substantial. We will limit the number of participants to 26 x 2 preterm infants and 10 control healthy infants.
Six Norwegian Neonatal Intensive care units wil participate in the study.
Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age (GA) \<28 weeks/birth birth weight (BW) \<1000 g).
The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.
Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity and taxonomy will be analysed using bioinformatic tools
Inclusion criteria:
* Preterm infants 24-27 weeks gestation/ birth weight \< 1000 g receiving probiotics
* Preterm infants 28-31 weeks gestation/BW 1000-1500 g not receiving probiotics
* Healthy term infants
Exclusion criteria
* Preterm infants \< 24 weeks gestation
* Preterm infants \< 32 weeks with severe lethal complication/poor prognosis around 1 week of age
* Infants with severe congenital malformations
Fecal samples will be obtained:
* 1 week of age
* 4 weeks of age
* 4 months corrected age
* 12 months corrected age
Study hypotheses:
* Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.
* Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.
* After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.
* A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.
This is an explorative study. No formal sample size assessment is possible. Sequencing costs will be substantial. We will limit the number of participants to 26 x 2 preterm infants and 10 control healthy infants.
Six Norwegian Neonatal Intensive care units wil participate in the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: