Trial document




drksid header

  DRKS00013197

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

primalstudy

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.gesundheitsforschung-bmbf.de/de/klinische-studie-uber-die-wirksamkeit-von-probiotika-zur-vermeidung-einer-ungunstigen-7527.php https://primal-studie.de/

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Aim: Gut dysbiosis is associated with acute and long-term health problems. Probiotics are widely used to prevent dysbiosis in extremely preterm infants. Yet, the evidence from studies is inconclusive and focused on short term effects. We aim to define the potential of probiotics for modulating both the intestinal microbiota and the developing immune system in preterm infants.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Gut dysbiosis, defined as a significant deviation of the gut microbiome from a healthy state (eubiosis), is associated with long-term health problems, specifically in vulnerable populations such as preterm infants. It appears that the developing flora of the newborn infant is particularly sensitive to disturbances, which may lead to long term dysbiosis. Specific diseases, such as sepsis and necrotizing enterocolitis, are associated with gut dysbiosis and immunological dysregulation. Dysbiosis might be ameliorated with probiotics and aggravated as a side effect of antibiotic treatment, which is administered to > 50% of preterm infants. However, multi-center, randomized-controlled studies in a well-defined cohort of VPI are few, focus on acute outcomes like necrotizing enterocolitis, and none has directly assessed the effects of probiotics and other interventions on the microbiome at high resolution and with respect to comprehensive immunophenotyping.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013197
  •   2018/03/23
  •   [---]*
  •   yes
  •   Approved
  •   17-130, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K63.8 -  Other specified diseases of intestine
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Lactobacillus acidophilus and Bifidobacterium longum and Bifidobacterium infantis, 1 /day p.o. (capsule), for 28 days
  •   Placebo, 1 /day p.o. (capsule), for 28 Tage
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/04/01
  •   654
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   28   Weeks of pregnancy
  •   32   Weeks of pregnancy
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof. Dr. med.  Christoph  Härtel 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof. Dr. med.  Christoph  Härtel 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof. Dr. med.  Christoph  Härtel 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn (Projektträger DLR, Heinrich-Konen-Str. 1, 53227 Bonn)
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.