Trial document



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  DRKS00013197

Trial Description

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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

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Trial Acronym

primalstudy

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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/

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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.

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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.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013197
  •   2018/03/23
  •   [---]*
  •   yes
  •   Approved
  •   17-130, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K63.8 -  Other specified diseases of intestine
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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
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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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.

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Countries of Recruitment

  •   Germany
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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 
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Recruitment

  •   Actual
  •   2018/04/01
  •   654
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   28   Weeks of pregnancy
  •   32   Weeks of pregnancy
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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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof. Dr. med.  Christoph  Härtel 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof. Dr. med.  Christoph  Härtel 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof. Dr. med.  Christoph  Härtel 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn (Projektträger DLR, Heinrich-Konen-Str. 1, 53227 Bonn)
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.