Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of the Neonatal Gut Microbiota. (MICROBIOTA-SO)
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|ClinicalTrials.gov Identifier: NCT02212002|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is influenced by several factors, such as mode of delivery, gestational age, maternal intestinal and vaginal microbiota, type of feeding, hospitalization after birth and use of antibiotics and probiotics.
Gut microbiota of term infants, vaginally delivered and exclusively breastfed, shows a low count of C. difficile and E. coli and a high number of Bifidobacteria and Lactobacilli, which positively influence the host's immunity processes; hence, is considered to be ideally healthy.
Group B Streptococcus (GBS) represents one of the most important causes of neonatal infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process from maternal vagina, cervix or rectum, where it resides in 10-20% of pregnant women. In the last decade, the incidence of early-onset GBS sepsis is significantly reduced, due to the introduction of GBS universal screening during late pregnancy and consequent intrapartum antibiotic prophylaxis (IAP) in GBS-positive women.
The use of antibiotics in early life is shown to alter the commensal gut microbiota, thereby impairing the balance between health and disease later in life. The effect of IAP on bacterial colonization of the infant's gut, however, has not been largely investigated. The investigators have previously evaluated the effect of IAP in a relatively small sample of exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at 7 days of life there were several differences in microbiota composition between infants IAP-exposed and not exposed.
This observational prospective study thus aims to evaluate these differences in further detail, expanding the initial sample to formula-fed term infants and following up infants until one month of age. By including formula-fed infants, the investigators additionally aim to evaluate the influence of feeding type on the neonatal microbiota composition.
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||84 participants|
|Observational Model:||Case Control|
|Official Title:||Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of Neonatal Gut Microbiota|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||August 2014|
Control group: infants born to GBS-negative mothers, who thus did not receive any antibiotic treatment before/at delivery.
IAP group: infants born to GBS-positive mothers who have received adequate intrapartum antibiotic prophylaxis (IAP). According to the Institutional treatment protocol for GBS prophylaxis (derived from CDC guidelines), intravenous ampicillin is given every 4 hours until delivery (first dose 2 g, following doses 1 g each). IAP is considered adequate when the mother received at least two doses of ampicillin before delivery.
maternal IAP, consisting of intravenous ampicillin given every 4 hours until delivery (first dose 2 g, following doses 1 g each).
- Faecal bacterial count [ Time Frame: One month ]Reduction in the faecal bacterial count (Bifidobacterium spp., Lactobacillus spp. and Bacteroides fragilis), assessed in term and vaginally delivered infants, in relation to IAP exposition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212002
|Nursery, S.Orsola-Malpighi Hospital|
|Bologna, Italy, 40138|