An observational study in Dermatitis, Atopic Dermatitis, Asthma (Diagnosis) and Eczema, sponsored by Bielefeld University. Recruiting at 1 site in Germany. Open to participants aged 0 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Bielefeld University · Observational
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Among 230 studies in Dermatitis, Atopic with a site in Germany — 19 open to participants now, 42 under way, 9 of them phase 3. Dermatitis, Atopic · Germany.
Among the 230 studies in Dermatitis, Atopic with a site in Germany, this one is the 7th largest by planned enrollment of the 21 observational ones that give a count, is one of 12 that started in 2024, is one of 21 observational ones, reaches primary completion later than 40 of the 41 other live ones, and was the 228th registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
Browse Dermatitis, Atopic studies →19 of the 230 studies in Dermatitis, Atopic with a site in Germany are open now. Recruiting first, the newest first:
Apollo Therapeutics Ltd · Sites in Germany, United States, Bulgaria and 5 more countries
Ages 18–65
Chong Kun Dang Pharmaceutical · Sites in Germany, United Kingdom
Ages 18–55 · Healthy volunteers
Pfizer · Sites in Germany, United States, Bulgaria and 6 more countries
Ages 18–64
University Hospital Schleswig-Holstein · Sites in Germany
Ages 18+
Galderma R&D · Sites in Germany, United States, United Kingdom
Ages 12+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 0 Days to 14 Days · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
230 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 86 · Phase 3 66 · Phase 4 11
First in 1998; this study’s year is marked. 12 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,200 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Median enrollment 195 across the 205 interventional studies, 634 across the 21 observational. Of the 184 that completed or were terminated, 95 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
195 of 230 have an industry lead sponsor. The 10 most frequent:
Bielefeld University is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Bielefeld University has 1 study filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
16 of the studies in Dermatitis, Atopic with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06241118Phase 3SanofiA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor | 2027-09-30 |
| NCT06395948Apogee Therapeutics, Inc.A Study Evaluating APG777 in Atopic Dermatitis | 2026-11 |
| NCT07358156Chong Kun Dang PharmaceuticalA Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants. | 2026-11-16 |
| NCT07230860Janssen Research & Development, LLCA Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis | 2026-11-19 |
| NCT05099315Charite University, Berlin, GermanyMicrobiome in Atopic Dermatitis Under Systemic Therapy | 2026-12-31 |
Add all 16 to your calendar (.ics) → With an account.
Among the 230 studies in Dermatitis, Atopic with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
Biological sampling:
Study objectives:
1000-1200 children born in Bielefeld (Germany) and surrounding area (≤ 40 km) and their families (mothers, optional: fathers, siblings).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participation of both mother and child (newborn) is mandatory; participation of the father and siblings is optional.
Inclusion Criteria:
Exclusion Criteria:
Longitudinal gut microbiome development (composition and diversity) in children
Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily: 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
Time frame: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Longitudinal gut metabolome development in children
Fecal metabolome analysis using targeted/ untargeted mass-spectrometry methods.
Time frame: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Longitudinal skin microbiome development (composition and diversity) in children
Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
Time frame: 2-14 days, 1-6 years (annually)
Longitudinal oral microbiome development (composition and diversity) in children
Analysis of microbiota composition and diversity using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
Time frame: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Longitudinal respiratory microbiome development (composition and diversity) in children
Analysis of microbiota composition and diversity using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
Time frame: 1-6 years (annually)
Longitudinal nasal microbiome development (composition and diversity) in children
Analysis of microbiota composition and diversity using next-generation sequencing (primarily 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
Time frame: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Short-term changes in the gut microbiome composition and diversity in children after antibiotic exposure
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).
Time frame: 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.
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).
Time frame: during infection (up to 7 days) - 4 weeks after infection (when occurring between birth- 6 years)
Number of children with allergic diseases
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.
Time frame: 1-6 years (annually)
Number of children with atopic dermatitis/ eczema
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.
Time frame: 1-6 years (annually)
Number of children with asthma.
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).
Time frame: 1-6 years (annually)
Number of children with overweight/ obesity (BMI-calculation)
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).
Time frame: 1-6 years (annually)
Number of children with functional gastrointestinal disorders
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.
Time frame: 1-6 years (annually)
Infection rate of the study child
Number of respiratory, gastrointestinal, ear/ eye or urinary tract infections per year
Time frame: 1-6 years (annually)
Bowel habits of the study child
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).
Time frame: 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
General health status of the study child
Number of health care visits, hospitalizations, or disease diagnoses per year.
Time frame: 1-6 years (annually)
Body Weight
Weight in kg.
Time frame: Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Growth
Height in cm
Time frame: Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Head Circumference
Head circumference in cm
Time frame: Birth, 2-14 days, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Child developmental milestones
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.
Time frame: 1-6 years (annually)
Bonding between mother and child
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.
Time frame: 4 weeks
Infant temperament
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.
Time frame: 6 month
Infant crying behaviour
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.
Time frame: 6 month
Child coping
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)
Time frame: 1-6 years (annually)
Child emotional regulation
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)
Time frame: 1-6 years (annually)
General psychosocial functioning in children
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.
Time frame: 2-6 years (annually)
Maternal gut microbiome composition and diversity
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.
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)
Maternal gut metabolome
Fecal metabolome analysis using targeted/ untargeted mass-spectrometry methods.
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)
Human milk microbiome composition and diversity
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).
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
Human milk metabolome analysis using targeted/ untargeted mass-spectrometry methods.
Time frame: 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
Analysis of microbiota composition, diversity, (function) using next-generation sequencing (primarily: 16S rRNA- amplicon sequencing; partially: ITS-amplicon sequencing, whole metagenome shotgun sequencing).
Time frame: 3rd trimester of pregnancy
Parental perceived stress
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.
Time frame: 3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Parental depression
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.
Time frame: 3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Parental anxiety
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.
Time frame: 3rd trimester of pregnancy, 4 weeks, 3 month, 6 month, 1-6 years (annually)
Plan to share: Yes
Started Mar 2024 (actual). Primary completion is estimated for Mar 2036, 144 months after the start.
Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 144 months is above that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Bielefeld University