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Vaccination and the human intestinal microbiome (µHEAT)

Vaccination and the human intestinal microbiome (µHEAT) - µHEAT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032373
Enrollment
256
Registered
2024-02-26
Start date
2021-11-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Vaccination

Interventions

Group 1: Booster immunization against SARS-CoV-2

Sponsors

Max Planck-Institut
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Participants were adults 18-40 years of age, with no underlying health conditions, belonging to the Robert Koch priority group 4. Participants must intend to be vaccinated against COVID-19 and be able to receive their vaccination during the study timeline (~Sept 2021-Dec 2022). Any of the COVID-19 vaccinations approved by the Robert Koch Institute at the time of study participation (e.g., BioNTech/Pfizer, Moderna, Johnson & Johnson or other commercially available vaccines) will be permitted for inclusion in the study, including booster shots. Participants must be able to read and understand German or English to provide informed consent for themselves.

Exclusion criteria

Exclusion criteria: Exclusion criteria include known gastrointestinal disorders (e.g., Inflammatory Bowel Disease or Celiac Disease), recent antibiotics use (any antibiotics taken in the three months prior to study participation), and pregnancy. Any health factor which places someone at higher risk of COVID-19 disease, and therefore in a higher vaccine priority group (1-3) according to the Robert Koch Institute will also be excluded. These exclusion risk factors, as listed by the Robert Koch Institute, include diabetes mellitus, obesity (BMI>30), asthma, autoimmune diseases, neurological diseases, cancer, and diseases of the lung, heart, liver, or kidney. Immunocompromised and immunosuppressed people are also explicitly excluded. However, healthy individuals who receive vaccine prioritization for occupational reasons (for example, researchers working at the hospital campus) are not excluded from the study.

Design outcomes

Primary

MeasureTime frame
Interplay of the intestinal microbiome and fever and antibody responses to SARS-CoV-2 vaccination

Secondary

MeasureTime frame
Temporal responsiveness of the intestinal microbiome to immunisation against SARS-CoV-2

Countries

Germany

Contacts

Public ContactRuth Ley

Max Planck Institute for Biology

ruth.ley@tuebingen.mpg.de+49 (0)7071 601-449

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026