Trial document
DRKS00013197
Trial Description
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
Trial Acronym
primalstudy
URL of the Trial
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.
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.
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
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- yes
- Approved
- 17-130, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
Secondary IDs
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Health Condition or Problem studied
- K63.8 - Other specified diseases of intestine
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
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist, caregiver, assessor
- Placebo
- Prevention
- Parallel
- N/A
- N/A
Primary Outcome
Determination of intestinal dysbiosis on day 28-30 using stool sample
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.
Countries of Recruitment
- Germany
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
Recruitment
- Actual
- 2018/04/01
- 654
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 28 Weeks of pregnancy
- 32 Weeks of pregnancy
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.
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.
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-sponsorstart of 1:1-Block address contact primary-sponsor- 0451 500 42801
- 0451 500 43064
- christoph.haertel at uksh.de
- http://uksh.de
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-contactstart of 1:1-Block address contact scientific-contact- 0451 500 42801
- 0451 500 43064
- christoph.haertel at uksh.de
- http://uksh.de
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-contactstart of 1:1-Block address contact public-contact- 0451 500 42801
- 0451 500 43064
- christoph.haertel at uksh.de
- http://uksh.de
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.bmbf.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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