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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 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

1200

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Niemcy
      • Bielefeld, Niemcy, 33617
        • Rekrutacyjny
        • University Hospital OWL, Bielefeld University, Department for Pediatrics
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

1 sekunda do 2 tygodnie (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Longitudinal gut microbiome development (composition and diversity) in children
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Short-term changes in the gut microbiome composition and diversity in children after antibiotic exposure
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 1-6 years (annually)

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Maternal gut microbiome composition and diversity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Bielefeld University

Współpracownicy

Maastricht University Medical Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 marca 2024

Zakończenie podstawowe (Szacowany)

1 marca 2036

Ukończenie studiów (Szacowany)

1 marca 2037

Daty rejestracji na studia

Pierwszy przesłany

6 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 listopada 2026

Pierwszy wysłany (Rzeczywisty)

13 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • LittleOwls_2022-600-f-S
  • 03LW0567K (Inny numer grantu/finansowania: BMFTR, German Federal Ministry of Research, Technology and Space)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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