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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 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

1200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Bielefeld, Allemagne, 33617
        • Recrutement
        • University Hospital OWL, Bielefeld University, Department for Pediatrics
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 seconde à 2 semaines (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Longitudinal gut microbiome development (composition and diversity) in children
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Short-term changes in the gut microbiome composition and diversity in children after antibiotic exposure
Délai: 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.
Délai: 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
Délai: 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
Délai: 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.
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1-6 years (annually)

Number of health care visits, hospitalizations, or disease diagnoses per year.
1-6 years (annually)
Body Weight
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Maternal gut microbiome composition and diversity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bielefeld University

Collaborateurs

Maastricht University Medical Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2024

Achèvement primaire (Estimé)

1 mars 2036

Achèvement de l'étude (Estimé)

1 mars 2037

Dates d'inscription aux études

Première soumission

6 octobre 2026

Première soumission répondant aux critères de contrôle qualité

6 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • LittleOwls_2022-600-f-S
  • 03LW0567K (Autre subvention/numéro de financement: BMFTR, German Federal Ministry of Research, Technology and Space)

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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