Health TrialsbyHealthPanel

Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

ConditionFood Protein-Induced Enterocolitis Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-60
SponsorNYU Langone Health

About this trial

This is a phase I multicenter clinical trial that aims to find the optimal dose for conducting a novel low-dose, multi-day oral food challenge (OFC) protocol for diagnosing food protein-induced enterocolitis syndrome (FPIES). Individuals ages 1-60 years with a history of suspected or confirmed FPIES will be eligible for enrollment. Recruitment is expected to occur over 3 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of appropriate consent and/or assent

Age 1-60 years

Suspected or confirmed FPIES diagnosis

Reported convincing FPIES reaction (per criteria in 2017 FPIES guidelines) within: (Children <18 years of age: The past 6-36 months) (Adults age >18 years: The past 6 months-10 years)

Disqualifiers

Past severe FPIES defined as hospitalization due to an acute FPIES reaction with neurological compromise or requiring life support

Acute FPIES reaction in the past 6 months

Frequent gastrointestinal symptoms: nausea, abdominal pain, reflux, heartburn, emesis, diarrhea, constipation per participant or guardian report or as evidenced by FPIES Symptoms Score (FPIES-SS)

Current active eosinophilic gastrointestinal disorders, inflammatory bowel disease, gastroesophageal reflux disease, or any other chronic gastrointestinal condition

Trial design

Design model

Sequential

Treatments tested in this trial

  • Supervised Low-Dose Oral Food Challenge (OFC)

    Other intervention

    All participants will undergo a supervised Low Dose OFC (300 mg food protein or amended) on Day 1.

  • At-Home Low-Dose Oral Food Challenge (OFC)

    Other intervention

    Participants who tolerate the Day 1 Low Dose OFC will undergo a daily Low-Dose OFC (300 mg food protein or amended) at home on Days 2-7.

  • Supervised High-Dose Oral Food Challenge (OFC)

    Other intervention

    Participants who tolerate the Days 1-7 Low Dose OFC will undergo a supervised High Dose OFC (maximum 3000 mg food protein) on Day 8.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 3 interventions
Group B: Cohort 2Experimental treatment 3 interventions
Group C: Cohort 3Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

The proportion of individuals with active FPIES who develop FPIES symptoms during the optimal Low Dose multi-day OFC (Days 1-7)

Time frame
Up to Day 7

Secondary outcomes

1

Percentage of participants who meet criteria for intravenous fluid (IVF) resuscitation among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)[Time Frame: Up to Day 7]

Time frame
Up to Day 7
2

Percentage of participants treated with oral ondansetron among those who develop FPIES symptoms during Low Dose multi-day OFC

Time frame
Up to Day 7
3

Percentage of participants treated with parenteral ondansetron among those who develop FPIES symptoms during Low Dose multi-day OFC

Time frame
Up to Day 7
4

Percentage of participants with hypotension among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)

Hypotension defined as: a systolic blood pressure (mmHg): age 1-10: Systolic \<70+(age in years x 2); 11 years or older: \<90 mmHg.

Time frame
Up to Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov
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