Study on the Association Between the Introduction of Complementary Feeding and Infant Gut Microbiome Composition
FamilyFeedBiome Pilot Project: Observational Study on the Association Between the Introduction of Complementary Feeding and the Composition of the Gut Microbiome in Infants
The goal of this observational study is to assess the feasibility of investigating the association between the introduction of complementary feeding and gut microbiome composition in infants. The main question it aims to answer is:
Can we reach the feasibility targets for questionnaire completeness and data quality, the proportion of stool samples suitable for analysis, protocol adherence, and recruitment rate?
Parents will complete questionnaires about their infant's health and nutrition and collect stool samples from their infant at three timepoints around the introduction of complementary feeding.
Study Overview
Status
Detailed Description
Patient and Public Involvement and Engagement (PPIE) is embedded throughout the planning, conduct and dissemination of this observational study.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Infants recruited from a pediatric practice and a University Children's Hospital.
Description
Inclusion Criteria:
- Healthy infants
- Formula or breastfed
- Born at term (≥ 37 weeks gestation)
- Parents/caregivers willing and able to collect stool samples and complete questionnaires
- Written informed consent signed by parent or caregiver
- Parent/caregiver at least 18 years of age
Exclusion Criteria:
- Preterm infants (< 37 weeks gestation)
- Infants with congenital or chronic conditions affecting digestion or the immune system
- Use of antibiotics within the last 4 weeks before start of complementary feeding
- Food allergies or intolerances that would significantly restrict complementary feeding
- Parents/caregivers have insufficient proficiency in German to understand study materials and provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of complete questionnaire data collection
Time Frame: At study completion, approximately 5 months
|
Percentage of questionnaires completed by recruited families (feasibility target: ≥ 80 %). |
At study completion, approximately 5 months
|
|
Feasibility of high-quality questionnaire data collection
Time Frame: At study completion, approximately 5 months
|
Percentage of families for whom no contradictory or inconsistent information is identified across the three questionnaires (feasibility target: ≥ 80 %). |
At study completion, approximately 5 months
|
|
Feasibility of adherence to questionnaire timepoints
Time Frame: At study completion, approximately 5 months
|
Percentage of answered questionnaires that comply with the predefined data collection timepoints between start of complementary feeding (CF) and T1, T2 and T3: T1 - CF: 0 - 8 days, CF - T2: 6 - 8 days, CF - T3: 13 - 15 days (feasibility target: ≥ 80 %). |
At study completion, approximately 5 months
|
|
Feasibility of adherence to stool sample collection timepoints
Time Frame: At study completion, approximately 5 months
|
Percentage of collected stool samples that comply with the predefined data collection timepoints between start of complementary feeding (CF) and T1, T2 and T3: T1 - CF: 0 - 8 days, CF - T2: 6 - 8 days, CF - T3: 13 - 15 days (feasibility target: ≥ 80 %). |
At study completion, approximately 5 months
|
|
Feasibility of collecting analyzable stool samples
Time Frame: At study completion, approximately 5 months
|
Percentage of collected stool samples for which 16S rRNA analysis was successfully completed (feasibility target: ≥ 90 %). |
At study completion, approximately 5 months
|
|
Feasibility of study participant recruitment
Time Frame: At study completion, approximately 5 months
|
Recruitment rate will be described as number of recruited study participants per month. Reasons of withdrawal will be reported. |
At study completion, approximately 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of PPIE activities assessed by the project leader using the Public and Patient Engagement Evaluation Tool (PPEET) project questionnaire and by the PPIE participants using a modified Patient Engagement in Research Scale (PEIRS) tool.
Time Frame: At study completion, approximately 5 months
|
The level of involvement achieved will be assessed by the project leader and PPIE participants using single-choice questions in the questionnaires. PPIE activities will be considered feasible if all PPIE activities can be conducted at the predefined level of involvement. Challenges and barriers encountered during the implementation of PPIE activities and their impact on the feasibility of PPIE activities will be assessed descriptively by the project leader and PPIE participants in the questionnaires. |
At study completion, approximately 5 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preliminary data on the association between complementary feeding and gut microbiome composition
Time Frame: 7 days before introduction of complementary feeding, 7 days after introduction of complementary feeding, 14 days after introduction of complementary feeding
|
Participant's health and dietary characteristics, as well as gut microbiome composition will be summarized at each timepoint using descriptive statistics. Where appropriate, plots will be used to visualize changes over time and patterns in gut microbiome composition. Gut microbiome composition will be described based on the relative abundance of the most common bacteria, microbial diversity within individual samples (α-diversity), and differences in overall microbial community composition between timepoints (β-diversity). Any statistical analyses investigating associations between the introduction of complementary feeding and gut microbiome composition will be considered explanatory and reported using confidence internals. These analyses will not include p-values or support confirmatory conclusions. |
7 days before introduction of complementary feeding, 7 days after introduction of complementary feeding, 14 days after introduction of complementary feeding
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026-01319
- 2026__SG_293 (Other Grant/Funding Number: Graduate Campus Universität Zürich)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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