Study on the Association Between the Introduction of Complementary Feeding and Infant Gut Microbiome Composition

NCT07852182 | Not Yet Recruiting

• 2 other identifiers: 2026-013192026__SG_293
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Feasibility Studies; Microbiome Composition; Complementary Feeding; Family Engagement

Outcome Measures

Primary Outcomes (6)

• Feasibility of complete questionnaire data collection

  Percentage of questionnaires completed by recruited families (feasibility target: ≥ 80 %).

  At study completion, approximately 5 months

• 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 %).

  At study completion, approximately 5 months

• 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 %).

  At study completion, approximately 5 months

• 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 %).

  At study completion, approximately 5 months

• Feasibility of collecting analyzable stool samples

  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

  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 Outcomes (1)

• 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.

  At study completion, approximately 5 months

Other Outcomes (1)

• Preliminary data on the association between complementary feeding and gut microbiome composition

  7 days before introduction of complementary feeding, 7 days after introduction of complementary feeding, 14 days after introduction of complementary feeding

Eligibility Criteria

• Age: 2 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants recruited from a pediatric practice and a University Children's Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: October 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09