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)

November 6, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Bielefeld, Germany, 33617
        • Recruiting
        • University Hospital OWL, Bielefeld University, Department for Pediatrics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Longitudinal gut microbiome development (composition and diversity) in children
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short-term changes in the gut microbiome composition and diversity in children after antibiotic exposure
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 1-6 years (annually)

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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal gut microbiome composition and diversity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bielefeld University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LittleOwls_2022-600-f-S
  • 03LW0567K (Other Grant/Funding Number: BMFTR, German Federal Ministry of Research, Technology and Space)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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