K63.8
Conditions
Interventions
Group 1: Lactobacillus acidophilus and Bifidobacterium longum and Bifidobacterium infantis, 1 /day p.o. (capsule), for 28 days
Group 2: Placebo, 1 /day p.o. (capsule), for 28 Tage
Sponsors
Universitätsklinikum Schleswig-Holstein
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria for participating in the PRIMAL trial in the first 48 hours of life are: 1. Patients (or as appropriate whose legal guardian) have been informed about the study procedures and interventions and have given written informed consent; 2. Female or male preterm infants born between 28 0/7 to 32 6/7 gestational weeks of any ethnic background, who are admitted to of the listed study sites within the first 48h of life.
Exclusion criteria
Exclusion criteria: 1. Infants with lethal malformations or severe gastrointestinal malformations, which preclude appropriate enteral feeding or require surgery within the primary observational time of 28 days. 2. Infants who primarily present with NEC (Bell´s stage = 1B) or with any medical condition that is likely to be lethal in the first 48 h of life.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of intestinal dysbiosis on day 28-30 using stool sample | — |
Secondary
| Measure | Time frame |
|---|---|
| In both groups significant deviations of the microbiome are determined. Further secondary endpoints are assumed symptoms or consequences of intestinal dysbiosis a) infection-related and b) metabolism. | — |
Countries
Germany
Contacts
Public ContactChristoph Härtel
Universitätsklinikum Schleswig-Holstein
Outcome results
None listed