Feasibility StudiesNCT07852182
Study on the Association Between the Introduction of Complementary Feeding and Infant Gut Microbiome Composition
An observational study of Feasibility Studies and Microbiome Composition, run by University Children's Hospital, Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies, Microbiome Composition, Complementary Feeding
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants recruited from a pediatric practice and a University Children's Hospital.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the detailed description
Patient and Public Involvement and Engagement (PPIE) is embedded throughout the planning, conduct and dissemination of this observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of complete questionnaire data collection
Percentage of questionnaires completed by recruited families (feasibility target: ≥ 80 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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.
Measured: 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.
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.
Measured: At study completion, approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852182
- Sponsor's protocol ID
- 2026-01319
- Other IDs
- 2026__SG_293
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FamilyFeedBiome Pilot Project: Observational Study on the Association Between the Introduction of Complementary Feeding and the Composition of the Gut Microbiome in Infants
- ClinicalTrials.gov ID
- NCT07852182
- Acronym / sponsor ID
- 2026-01319
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patient and Public Involvement and Engagement (PPIE) is embedded throughout the planning, conduct and dissemination of this observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants recruited from a pediatric practice and a University Children's Hospital.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of complete questionnaire data collection
Time frame: At study completion, approximately 5 months
Percentage of questionnaires completed by recruited families (feasibility target: ≥ 80 %).
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 %).
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 %).
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 %).
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 %).
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Feasibility Studies and Microbiome Composition, run by University Children's Hospital, Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of complete questionnaire data collection (time frame: At study completion, approximately 5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.