PRIMAL Clinical Study: Efficacy of probiotics to prevent gut dysbiosis in very preterm infants (VPIs) and moderate preterm infants of 28+0 – 32+6 weeks of gestation: A randomized, placebo-controlled double-blind study

Not Applicable

Recruiting

• Conditions: K63.8; Other specified diseases of intestine

• Registration Number: DRKS00013197
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 654

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of intestinal dysbiosis on day 28-30 using stool sample

Secondary Outcome Measures

Name	Time	Method
In both groups significant deviations of the microbiome are determined.<br>Further secondary endpoints are assumed symptoms or consequences of intestinal dysbiosis a) infection-related and b) metabolism.