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The LITTLE OWLS Study (in German: "Kleine Eulen OWL"): Exploring the Early-life Microbiome Development and Physical and Mental Health Outcomes During Childhood. (LITTLE OWLS)

6. november 2026 opdateret af: Univ.-Prof. Dr. med. Eckard Hamelmann, Bielefeld University

LITTLE OWLS Children's Health Study

The LITTLE OWLS study is a prospective, longitudinal birth cohort study investigating early-life microbiome development and its association with physical and mental health outcomes during childhood. Recruitment began in 2024, enrolling families from late pregnancy through the child's first 6 years of life, with a target of at least 1000- 1200 children and their families.

The study characterizes longitudinal microbiome trajectories-including resilience and dysbiosis-and their relationship to common chronic diseases. Data are collected via online surveys, symptom and medication diaries, annual clinical exams, and repeated biological sampling of the child, mother, father/partner, siblings, and household environment. Findings are intended to support future diagnostics, prevention, and therapy for common chronic physical and mental diseases.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Detaljeret beskrivelse

Chronic physical and mental diseases in childhood are increasingly linked to early alterations in the human microbiome, yet the temporal dynamics of microbiome establishment across different body sites, family members, and environmental contexts remain incompletely understood. The LITTLE OWLS study addresses this gap through a prospective, longitudinal birth cohort design that follows families from late pregnancy through the child's sixth year of life.

Data collection:

  • Online surveys at 12 time points, capturing child and family health, medical history, and social, environmental, and lifestyle factors
  • Continuous symptom and medication diaries, allowing fine-grained tracking of the child's health trajectory between survey waves
  • Annual clinical examinations, providing standardized clinical assessments

Biological sampling:

  • Child: repeated sampling of the gut, skin, oral, nasal, and respiratory microbiome to capture developmental trajectories at multiple body sites
  • Mother: vaginal and gut microbiome samples, and lactation-related samples (e.g., human milk), which may inform understanding of microbial transmission from mother to child
  • Father/partner and siblings: biological samples from participating family members
  • Household environment: environmental samples (e.g., house dust)

Study objectives:

  • Characterize both stable (resilient) and disrupted (dysbiotic) patterns of microbiome development
  • Examine the temporal association between these patterns and the emergence of common chronic diseases
  • Identify microbial and environmental markers linked to disease risk
  • Help clarify the potential causal role of these markers in health outcomes Beyond its immediate research aims, the cohort is intended to serve as a long-term resource for the field, providing a foundation for the development of improved diagnostic approaches, prevention strategies, and targeted therapies for common chronic physical and mental diseases affecting children.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
1200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Tyskland
      • Bielefeld, Tyskland, 33617
        • Rekruttering
        • University Hospital OWL, Bielefeld University, Department for Pediatrics
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

1 sekund til 2 uger (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

1000-1200 children born in Bielefeld (Germany) and surrounding area (≤ 40 km) and their families (mothers, optional: fathers, siblings).

Beskrivelse

Participation of both mother and child (newborn) is mandatory; participation of the father and siblings is optional.

Inclusion Criteria:

  • mothers age ≥18 years at the time of enrollment
  • newborn age: max. 14 days after birth at the time of enrollment
  • sufficient proficiency in the study language (German)
  • residence ≤ 40 km from Bielefeld city center, to ensure feasibility of long-term follow-up

Exclusion Criteria:

  • no written study consent
  • no ability to participate in the study (incl. self-sampling, online-questionnaires, study visits) according to the investigator´s instructions

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Longitudinal gut microbiome development (composition and diversity) in children
Tidsramme: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily: 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Longitudinal gut metabolome development in children
Tidsramme: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Fecal metabolome analysis using targeted/ untargeted mass-spectrometry methods.
2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Longitudinal skin microbiome development (composition and diversity) in children
Tidsramme: 2-14 days, 1-6 years (annually)

Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
2-14 days, 1-6 years (annually)
Longitudinal oral microbiome development (composition and diversity) in children
Tidsramme: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Analysis of microbiota composition and diversity using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Longitudinal respiratory microbiome development (composition and diversity) in children
Tidsramme: 1-6 years (annually)

Analysis of microbiota composition and diversity using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
1-6 years (annually)
Longitudinal nasal microbiome development (composition and diversity) in children
Tidsramme: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Analysis of microbiota composition and diversity using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Short-term changes in the gut microbiome composition and diversity in children after antibiotic exposure
Tidsramme: during medication (up to last day of medication) - 4 weeks after medication (when occurring between birth- 6 years)

Changes in gut microbiome composition, diversity, (function) following perturbations by antibiotic use analyzed by next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
during medication (up to last day of medication) - 4 weeks after medication (when occurring between birth- 6 years)
Short-term changes in the gut microbiome composition and diversity in children after gastrointestinal infections.
Tidsramme: during infection (up to 7 days) - 4 weeks after infection (when occurring between birth- 6 years)

Changes in gut microbiome composition, diversity, (function) following perturbations by gastrointestinal infections analyzed by next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
during infection (up to 7 days) - 4 weeks after infection (when occurring between birth- 6 years)
Number of children with allergic diseases
Tidsramme: 1-6 years (annually)

Physician-diagnosed allergy (wheeze, allergic rhinitis, food allergy). From 2-years of age allergic symptoms are further recorded during the annual study examinations using the ISAAC questionnaire.
1-6 years (annually)
Number of children with atopic dermatitis/ eczema
Tidsramme: 1-6 years (annually)

Physician-diagnosed atopic dermatitis/ eczema. From 1-year of age the skin status of each study child is further screened based on SCORAD (SCORing Atopic Dermatitis). The score evaluates three distinct areas: extend, intensity, subjective symptoms. The overall score ranges from 0 to 103: < 25: Mild Atopic Dermatitis, 25 - 50: Moderate Atopic Dermatitis, > 50: Severe Atopic Dermatitis.
1-6 years (annually)
Number of children with asthma.
Tidsramme: 1-6 years (annually)

Physician-diagnosed asthma. From 2-years of age, asthmatic symptoms are further recorded during the annual study examinations using the International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire (calculating the percentage frequencies of wheezing, eczema, and rhinitis symptoms over the last 12 month).
1-6 years (annually)
Number of children with overweight/ obesity (BMI-calculation)
Tidsramme: 1-6 years (annually)

Physician-diagnosed overweight or obesity. Further the Body Mass Index (kg/m²) is calculated for each study child (annually) as weight (kg) divided by the square of length or height (in meters).
1-6 years (annually)
Number of children with functional gastrointestinal disorders
Tidsramme: 1-6 years (annually)

Physician-diagnosed functional gastrointestinal disorders (like chronic constipation, diarrhea or irritable bowel syndrome (IBS). From 1-year of age, functional gastrointestinal symptoms are further recorded during the annual study examinations using the R4PDQ questionnaires (Rome foundation) according to the Rome IV criteria (1-3 years; 4 years +). The R4DQ uses a mix of Likert-type scales, yes/no, and multiple-choice questions to assess symptom severity and frequency. Scoring varies by module, with no universal cut-off scores.
1-6 years (annually)
Infection rate of the study child
Tidsramme: 1-6 years (annually)

Number of respiratory, gastrointestinal, ear/ eye or urinary tract infections per year
1-6 years (annually)
Bowel habits of the study child
Tidsramme: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Bowel habits measured by stool frequency, stool consistency and stool colour. Bowel habit information and Bristol Stool Scale scores are documented with each fecal sample collection (Type 1-7, hard-watery).
2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
General health status of the study child
Tidsramme: 1-6 years (annually)

Number of health care visits, hospitalizations, or disease diagnoses per year.
1-6 years (annually)
Body Weight
Tidsramme: Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Weight in kg.
Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Growth
Tidsramme: Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Height in cm
Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Head Circumference
Tidsramme: Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Head circumference in cm
Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Child developmental milestones
Tidsramme: 1-6 years (annually)

Child developmental milestones are examined during the annual study visits using pediatric questionnaires (German: "Grenzsteine der kindlichen Entwicklung") for cognitive, motor, socio-emotional and verbal development.
1-6 years (annually)
Bonding between mother and child
Tidsramme: 4 weeks

Mother-infant bonding is assessed at 4 weeks after birth using the Postpartum Bonding Questionnaire (PBQ). The PBQ uses a 6-point Likert scale (0 = Always to 5 = Never), yielding a maximum total score of 125. High scores indicate greater bonding difficulties, while low scores indicate a healthy mother-infant relationship.
4 weeks
Infant temperament
Tidsramme: 6 month

The infant temperament development of the child is examined using the Infant Behavior Questionnaire (IBQ) at 6 month of age. Parents rate behaviors observed over the past week or two on a 7-point Likert scale (from 1 = never to 7 = always, plus a "does not apply" option). Scale scores are calculated as the mean score of all applicable items answered (excluding "does not apply" choices). Scores are independently rated for each of the 6 Core Temperament Dimensions: Activity Level, Soothability, Fear, Distress to Limitations, Smiling and Laughter, Duration of Orienting. Higher mean scores indicate a greater frequency of that specific behavioral temperament trait.
6 month
Infant crying behaviour
Tidsramme: 6 month

The infant crying behaviour is examined using the Infant Behavior Questionnaire (IBQ) at 6 month of age. Parents rate behaviors observed over the past week or two on a 7-point Likert scale (from 1 = never to 7 = always, plus a "does not apply" option). Scale scores are calculated as the mean score of all applicable items answered (excluding "does not apply" choices). Scores are independently rated for each of the 6 Core Temperament Dimensions: Activity Level, Soothability, Fear, Distress to Limitations, Smiling and Laughter, Duration of Orienting. Higher mean scores indicate a greater frequency of that specific behavioral temperament trait.
6 month
Child coping
Tidsramme: 1-6 years (annually)

Coping behaviour of children is assessed annually using the Emotional regulation/ impulse management questionnaire (IMMA-6 short version) starting from 1 year of age. The calculation of results follows standard psychometric scoring rules for 6-point Likert-scale questionnaires. The three main scales (core dimensions) are evaluated: 1) Child's Self-Regulation (C-Scale), 2) Parental Co-Regulation (P-Scale), 3) Parental Expectations/Goals (E-Scale)
1-6 years (annually)
Child emotional regulation
Tidsramme: 1-6 years (annually)

Emotional regulation of children is assessed annually using the Pediatric Symptom Checklist (IMMA) starting from 1 year of age. The calculation of results follows standard psychometric scoring rules for 6-point Likert-scale questionnaires. The three main scales (core dimensions) are evaluated: 1) Child's Self-Regulation (C-Scale), 2) Parental Co-Regulation (P-Scale), 3) Parental Expectations/Goals (E-Scale)
1-6 years (annually)
General psychosocial functioning in children
Tidsramme: 2-6 years (annually)

General psychosocial functioning in children (and potential emotional and behavioral difficulties) is examined using the Pediatric Symptom Checklist (PSC-35). The Pediatric Symptom Checklist (PSC) is scored by assigning points to each response (0 for "never", 1 for "sometimes", and 2 for "often") calculating a total score. A total score of 24 or higher (from 3-6 years) indicates a positive screening result for psychosocial impairment. If four or more items are left blank, the questionnaire is considered invalid and cannot be scored.
2-6 years (annually)

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal gut microbiome composition and diversity
Tidsramme: 3rd trimester of pregnancy, birth; only for breast-feeding mothers: 2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)

Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily: 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing). The mothers' stool samples will continue to be collected annually after the first year of life until the end of the breastfeeding period (on an individual basis for each mother). In addition, a stool sample will be collected and analyzed 1-3 days after the last breastfeeding session and 4 weeks thereafter.
3rd trimester of pregnancy, birth; only for breast-feeding mothers: 2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)
Maternal gut metabolome
Tidsramme: 3rd trimester of pregnancy, only for breast-feeding mothers: 2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)

Fecal metabolome analysis using targeted/ untargeted mass-spectrometry methods.
3rd trimester of pregnancy, only for breast-feeding mothers: 2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)
Human milk microbiome composition and diversity
Tidsramme: 2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)

Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily: 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing). The mothers' milk samples will continue to be collected annually after the first year of life until the end of the breastfeeding period (on an individual basis for each mother).
2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)
Human milk metabolome
Tidsramme: 2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)

Human milk metabolome analysis using targeted/ untargeted mass-spectrometry methods.
2-14 days, 4 weeks, 3 month, 6 month, annually (individual, until end of lactation period, assessed up to max. 5 years)
Maternal vaginal microbiome composition and diversity
Tidsramme: 3rd trimester of pregnancy

Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily: 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
3rd trimester of pregnancy
Parental perceived stress
Tidsramme: 3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Parental mental health is analysed for perceived stress using the Perceived Stress Scale Questionnaire (PSS-10). The PSS-10 evaluates how unpredictable, uncontrollable, and overloaded a person has found their life over the past month. The final total score will range from 0 to 40. Higher point values represent a higher level of perceived stress.
3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Parental depression
Tidsramme: 3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Parental mental health is analysed for depression using the Patient Health Questionnaire (PHQ-9). The PHQ-9 scores depressive symptom severity over the past two weeks using a 0 to 27 point scale. A score of 10 or higher is generally considered the threshold for a positive screening, warranting further clinical evaluation.
3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Parental anxiety
Tidsramme: 3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Parental mental health is analysed for anxiety using the Generalized Anxiety Disorder scale (GAD-7). The GAD-7 scoring and analysis scheme calculates a single cumulative severity score ranging from 0 to 21 by summing the ratings of seven individual items. The Cut-Off of ≥ 10 serves as the standard threshold for identifying probable cases of Generalized Anxiety Disorder.
3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Bielefeld University

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Maastricht University Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. marts 2024

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. marts 2036

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. marts 2037

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
6. oktober 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
6. november 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
6. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • LittleOwls_2022-600-f-S
  • 03LW0567K (Andet bevillings-/finansieringsnummer: BMFTR, German Federal Ministry of Research, Technology and Space)

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Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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