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NCT06300697

Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from University of Michigan

Track this trial

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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 2027 to Mar 2028
    • Eligibility criteria expanded, about 12 words
  2. Site contact updatedv3
  3. Start date changed from estimate of Mar 2024 to Feb 15, 2024v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Anaphylaxis occurrence rates in each group
Timeframe: Approximately 4 hours (Day 1 during the food challenge)

Secondary (3)

Anaphylaxis severity in each group
Reaction rates in each group
Anaphylaxis likelihood in each group based on the Brighton score

Arms and interventions

Control group AdultOther

Participation will be approximately 14 days after enrollment.

Food allergy-only groupOther

Participation will be approximately 14 days after enrollment.

Food allergy plus atopic dermatitis groupOther

Participation will be approximately 14 days after enrollment.

Atopic dermatitis without food allergy groupOther

Participation will be approximately 14 days after enrollment.

Control Group less than 18 years oldOther

Participation will be approximately 14 days after enrollment.

Other: Data and biospecimen collection, Skin biopsies, Oral Food Challenge (OFC) procedures

Sites

1 site in 1 country

  • University of MichiganAnn Arbor, Michigan, United States