Mixed Flora; Infection Clinical Trial
— PINGUOfficial title:
Gut Microbiome Study in Preterm Infants - a Norwegian Multi Centre Study
| NCT number | NCT02197468 |
| Other study ID # | 2014/930 (REK) |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2015 |
| Est. completion date | November 2015 |
| Verified date | June 2016 |
| Source | University Hospital of North Norway |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 12 Months |
| Eligibility |
Inclusion Criteria: - Preterm infants with gestational age 24-27 weeks/birth weight < 1000 g, treated with probiotics (target number 26) - Preterm infants with gestational age 29-31 weeks/birth weight 1000-1500 g, not treated with probiotics (target number 26) - Term infants (target number 10) Exclusion Criteria: - Extremely preterm infants with gestational age below 24 weeks - Preterm infants (24-31 weeks) with life threatening complications during 1 week of age - Infants with congenital malformations |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Haukeland Universtiy Hospital | Bergen | |
| Norway | Ahus University Hospital | Oslo | |
| Norway | Oslo University Hospital, Rikshospitalet | Oslo | |
| Norway | Oslo University Hospital, Ullevaal | Oslo | |
| Norway | Stavanger University Hospital | Stavanger | |
| Norway | University Hospital of North Norway | Tromsø | |
| Norway | St Olavs Hospital, Trondheim University Hospital | Trondheim |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of North Norway | Haukeland University Hospital, Helse Stavanger HF, Oslo University Hospital, St. Olavs Hospital, Ullevaal University Hospital, University of Tromso |
Norway,
Berrington JE, Stewart CJ, Cummings SP, Embleton ND. The neonatal bowel microbiome in health and infection. Curr Opin Infect Dis. 2014 Jun;27(3):236-43. doi: 10.1097/QCO.0000000000000061. Review. — View Citation
Stewart CJ, Marrs EC, Magorrian S, Nelson A, Lanyon C, Perry JD, Embleton ND, Cummings SP, Berrington JE. The preterm gut microbiota: changes associated with necrotizing enterocolitis and infection. Acta Paediatr. 2012 Nov;101(11):1121-7. doi: 10.1111/j.1651-2227.2012.02801.x. Epub 2012 Aug 31. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Cross contamination of probiotic bacteria in a NICU | Detection of probiotic bacterial microbiome profiles in children not receiving probiotics | 7 days of age and 4 weeks of age | |
| Primary | To assess gut microbiome composition (meta genome sequencing) of preterm infants receiving probiotics versus preterm infants not receiving probiotics | Stools samples from preterm infants and term infants (control) | 4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age | |
| Secondary | Impact of antibiotic exposure on gut microbiome | Stool samples from preterm and term infants | 4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age |