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.
Healthy infants
Formula or breastfed
Born at term (≥ 37 weeks gestation)
Parents/caregivers willing and able to collect stool samples and complete questionnaires
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
Infants recruited from a pediatric practice and a University Children's Hospital.
Cohort
Prospective
Not listed
Feasibility of complete questionnaire data collection
Percentage of questionnaires completed by recruited families (feasibility target: ≥ 80 %).
Feasibility of high-quality questionnaire data collection
Percentage of families for whom no contradictory or inconsistent information is identified across the three questionnaires (feasibility target: ≥ 80 %).
Feasibility of adherence to questionnaire timepoints
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 %).
Feasibility of adherence to stool sample collection timepoints
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 %).
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.
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.
Preliminary data on the association between complementary feeding and gut microbiome composition
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.
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