Priming immunity at the beginning of life: PRIMAL-Klinische Studie

Overview
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Die PRIMAL-Klinische Studie untersuchte bei 622 Frühgeborenen, die in der 28. bis 33. Schwangerschaftswoche geboren wurden, ob die frühe Gabe von Probiotika (Nahrungsergänzungsmittel aus Milchsäure- und Bifidusbakterien) eine Darm-Dysbiose vermeiden und die Prägung der Immunabwehr günstig beeinflussen kann. Die multizentrische Studie wurde randomisiert, doppelt verblindet und Placebo-kontrolliert durchgeführt. Sie ist Teil des PRIMAL-Konsortiums, das das Wechselspiel zwischen Mikrobiom und Immunität auch auf zellulärer Ebene untersucht.

SEEK ID: https://ldh.uksh.imise.uni-leipzig.de/projects/4

Public web page: https://primal-studie.de/

NFDI4Health PALs: No PALs for this Project

Project created: 26th Jun 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-30000

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Priming immunity at the beginning of life: PRIMAL - Klinische Studie
Language of the title/name : English

Acronym(s) of the Project

Acronym : PRIMAL
Language of the acronym : English

Description(s) of the Project

Description : Die PRIMAL-Klinische Studie untersuchte bei 622 Frühgeborenen, die in der 28. bis 33. Schwangerschaftswoche geboren wurden, ob die frühe Gabe von Probiotika (Nahrungsergänzungsmittel aus Milchsäure- und Bifidusbakterien) eine Darm-Dysbiose vermeiden und die Prägung der Immunabwehr günstig beeinflussen kann. Die multizentrische Studie wurde randomisiert, doppelt verblindet und Placebo-kontrolliert durchgeführt. Sie ist Teil des PRIMAL-Konsortiums, das das Wechselspiel zwischen Mikrobiom und Immunität auch auf zellulärer Ebene untersucht.
Language of the description : German

Keyword(s) describing the Project

Keyword(*) : Clinical study, Dysbiosis, preterm infant, prebiotics

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitätsklinikum Schleswig-Holstein
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : info@uksh.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Universitätsklinikum Schleswig-Holstein
Address : Ratzeburger Allee 160
Web page : https://www.uksh.de/
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00013197

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Dysbiosis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : K59.9
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the digestive system (XI)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : No
Start date : Not specified
End date : Not specified
Mono- or multicentric? : Multicentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : []
Inclusion criteria : Not specified
Exclusion criteria : Not specified
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : dysbiosis
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : at 30th day of life
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Yes, there is a plan to make data available
Supporting documents available in addition to the data : Study protocol, Statistical analysis plan, Informed consent form
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-3
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Investigator, Outcomes assessor
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : No

Priming immunity at the beginning of life: PRIMAL-Klinische Studie

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