BridgeMD
New treatment option for Food Protein-Induced Enterocolitis Syndrome
Official title Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
ClinicalTrials.gov ID: NCT06683521
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 60
You may be able to join if
- 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: The past 6 months-10 years)
- Individuals of childbearing potential practicing sexual abstinence or using effective methods of contraception during study participation
You likely can't join if
- 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...
- Current active eosinophilic gastrointestinal disorders, inflammatory bowel disease, gastroesophageal reflux disease, or any other chronic...
- Poorly controlled atopic dermatitis at screening per PI discretion
- Poorly controlled or severe asthma/wheezing at screening, defined by at least one of the following criteria: 1: History of two or more systemic...
See the full eligibility criteria
- 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: The past 6 months-10 years)
- Individuals of childbearing potential practicing sexual abstinence or using effective methods of contraception during study participation
- English-speaking
- 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
- Poorly controlled atopic dermatitis at screening per PI discretion
- Poorly controlled or severe asthma/wheezing at screening, defined by at least one of the following criteria: 1: History of two or more systemic corticosteroid courses within six months of screening or one course of...
- IgE-mediated food allergies where the trigger has not been identified
- Inability to discontinue prohibited medications for 7 days prior to the screening visit and lasting for the duration of study participation unless indicated for use as rescue medication
- Personal or family history of prolonged QT syndrome
- Personal history of arrhythmia
- Current diagnosis of arterial hypertension
- Current diagnosis of cardiovascular disease
- Current diagnosis of any chronic autoimmune disease
- Current diagnosis of liver disease
- Primary or secondary immunodeficiency
- Phenylketonuria (PKU) (ondansetron tablets may contain phenylalanine)
- Use of systemic steroids within 30 days of screening
- Chemotherapy, radiotherapy, or any systemic immunosuppressive drugs in the past 12 months
- Use of biologic drugs or allergen-specific immunotherapy by any route in the past 12 months
- Inability to defer routine immunizations or passive immunization with immune globulin for the duration of participation in the study
- Allergy to any of the following medications: ondansetron (Zofran), dolasetron (Azemet), granisetron (Kytril), or palonosetron (Aloxi)
- Pregnancy or breastfeeding
- Current or past medical problems or findings from the physical examination or screening evaluation not listed above, which, in the opinion of the investigator(s), may pose additional risks from study participation...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.