Oral Food Challenge for Food Intolerance

(INFINITY Trial)

Recruiting at 1 trial location

Overseen By Joseline Cruz Vazquez, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Systemic steroids, Biologic drugs

Disqualifiers: Severe FPIES, Eosinophilic disorders, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

72 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications for 7 days before the screening visit and throughout the study, unless they are needed as rescue medications.

What data supports the effectiveness of the treatment At-Home Low-Dose Oral Food Challenge, Supervised High-Dose Oral Food Challenge, Supervised Low-Dose Oral Food Challenge for food intolerance?

Oral food challenges are effective for diagnosing food allergies and intolerances, as they help determine if a person can safely consume certain foods. Studies show that low-dose oral food challenges are generally safe and can help manage food allergies by confirming whether a food can be reintroduced into the diet without causing adverse reactions. ^{1 2 3 4 5}

Is the oral food challenge generally safe for humans?

Oral food challenges are generally safe, with reactions being mild and self-limited. They are conducted under supervision to diagnose food allergies, and negative results allow the reintroduction of foods into the diet. ^{1 2 5 6 7}

How does the Oral Food Challenge treatment for food intolerance differ from other treatments?

The Oral Food Challenge treatment is unique because it involves a controlled process to diagnose food intolerance by gradually introducing the suspected food under medical supervision, which helps determine the specific food causing the reaction and the threshold dose that triggers symptoms. Unlike other treatments, it provides a direct and personalized assessment of food tolerance, allowing for accurate dietary recommendations. ^{1 7 8 9 10}

Research Team

Anna Nowak-Wegrzyn, MD, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals aged 1-60 with suspected or confirmed food protein-induced enterocolitis syndrome (FPIES), a condition causing digestive distress after eating certain foods. Details on who can't join are not provided.

Inclusion Criteria

I am between 1 and 60 years old.

Suspected or confirmed FPIES diagnosis

Reported convincing FPIES reaction within specified time frames

Exclusion Criteria

IgE-mediated food allergies where the trigger has not been identified

Inability to discontinue prohibited medications for specified duration

I have been diagnosed with high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline

Participants complete a baseline gastrointestinal symptom diary

1 day

1 visit (in-person)

Low Dose Oral Food Challenge

Participants undergo a supervised Low Dose OFC to their FPIES trigger

1 day

1 visit (in-person)

Home Challenge

Participants who do not react at the Day 1 Low Dose OFC continue with a daily home challenge

6 days

Daily monitoring (home-based)

High Dose Oral Food Challenge

Participants who tolerated the home challenges undergo a High Dose OFC

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the challenges

4 weeks

Treatment Details

Interventions

• At-Home Low-Dose Oral Food Challenge
• Supervised High-Dose Oral Food Challenge
• Supervised Low-Dose Oral Food Challenge

Trial Overview The study tests different ways to diagnose FPIES using oral food challenges: high-dose and low-dose supervised in a clinic, and low-dose at home. It aims to find the safest and most effective dose for these tests.

Participant Groups

Group I: Cohort 3 Experimental Treatment 3 Interventions

Participants will be sequentially enrolled into 3 cohorts of 24 each. Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.

Group II: Cohort 2 Experimental Treatment 3 Interventions

Participants will be sequentially enrolled into 3 cohorts of 24 each. Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.

Group III: Cohort 1 Experimental Treatment 3 Interventions

Participants will be sequentially enrolled into 3 cohorts of 24 each. The first cohort will undergo Low Dose OFC to 300 mg food protein. Following interim analysis of Low Dose OFC outcomes in cohort 1, the Low Dose OFC serving size may be amended or continued at 300 mg food protein for cohort 2 \& 3 based on pre-specified criteria.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

Oral food challenges are essential procedures performed by allergists to accurately diagnose food allergies, taking into account patient history, skin prick tests, and specific IgE levels.

The results of these challenges guide dietary decisions: a negative result allows the reintroduction of the food into the diet, while a positive result confirms the need to avoid the food, ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Work Group report: oral food challenge testing. Nowak-Wegrzyn, A., Assa'ad, AH., Bahna, SL., et al.[2022]

In a study involving 25 patients with a history of food allergies, 71 oral food challenges resulted in 12 positive reactions, confirming the patients' adverse reactions to specific foods, while all 12 placebo challenges were negative.

Follow-up after 10 to 12 months showed that 6 out of 9 patients with negative challenges were able to safely reintroduce the challenge food into their diet, indicating that some patients may outgrow their food sensitivities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of immediate adverse reactions to foods in adult patients. II. A detailed analysis of reaction patterns during oral food challenge. Atkins, FM., Steinberg, SS., Metcalfe, DD.[2019]

A study of 108 children undergoing low-dose oral food challenges (OFC) for eggs, milk, and wheat in a general hospital found that nearly half (49%) experienced allergic reactions, but all were mild to moderate, with no severe reactions or fatalities reported.

The results suggest that low-dose OFCs can be safely conducted in a general hospital setting without allergy specialists, highlighting their importance in managing food allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Low-Dose Oral Food Challenges for Hen's Eggs, Cow's Milk, and Wheat: Report from a General Hospital without Allergy Specialists in Japan. Nakanishi, K., Okafuji, I., Kihara, T., et al.[2023]

In a study of 365 children undergoing food challenges, 40% tested positive for food allergies, with 7% reacting to as little as 1 mg of protein, indicating that early responses can occur and highlighting the need for careful monitoring during testing.

The study found that achieving the recommended cumulative dose of 3,500 mg of allergen protein was not feasible for most children using the gingerbread matrix, suggesting that lower cumulative doses could be effective without increasing the risk of false negatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Reaction Thresholds of Double-Blind, Placebo-Controlled Peanut and Nut Food Challenges Using Gingerbread Matrix. van de Vorst-van der Velde, K., Andela, P., de Groot, H., et al.[2023]

Oral food challenges, particularly open challenges supervised by trained personnel, are effective and relatively safe methods for diagnosing food allergies, especially in infants and young children.

While double-blind, placebo-controlled food challenges provide definitive results, they are often impractical due to their complexity and cost, making open challenges a more feasible option in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral food challenges in children. Yum, HY., Yang, HJ., Kim, KW., et al.[2021]

A study involving 114 patients with peanut allergy demonstrated that a three-level stepwise oral food challenge (OFC) using peanut butter is safe, with only one participant requiring adrenaline during the highest dose.

The OFC showed positive reactions in 52% of participants at the lowest dose (0.1g), decreasing to 20% at the highest dose (3g), indicating that reactions are more common at lower doses, which is important for assessing allergy severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[SAFETY OF A THREE-LEVEL STEPWISE ORAL FOOD CHALLENGE FOR PEANUT ALLERGY]. Nihei, M., Sato, T., Horino, S., et al.[2019]

Oral food challenges are important for diagnosing food intolerances, particularly in children, but they can also pose risks, especially when testing for food additives and drugs.

These challenges should be conducted alongside other diagnostic methods, such as skin tests and in vitro tests, to ensure safety and accuracy in identifying allergens like cow's milk, eggs, and fish.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral provocation tests (OPT) in the skin pathology of children]. Sayag, J., Lagrange, B.[2006]

Oral food challenges are essential for diagnosing and managing food allergies, helping to confirm adverse reactions, determine individual threshold doses, and track progress in desensitization during immunotherapy.

To ensure accurate results, the food used in these challenges is carefully prepared to mask the allergenic component, preventing bias from sensory detection by patients or observers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of Blinded Food Matrixes for Clinical Oral Challenges. Nordlee, JA., Baumert, JL., Taylor, SL.[2023]

In a study of 584 oral food challenges conducted over 7 years, 43% resulted in allergic reactions, with the majority being cutaneous (78%) and gastrointestinal (43%) symptoms, but no severe cardiovascular reactions were reported.

All reactions were manageable with treatments like antihistamines and epinephrine, and importantly, no children required hospitalization, indicating that while there are risks, they can be effectively managed in a controlled environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of oral food challenges. Perry, TT., Matsui, EC., Conover-Walker, MK., et al.[2022]

Food allergies in children are common, but only a small number have clinically relevant allergies, primarily to foods like cow's milk, eggs, peanuts, and tree nuts.

The double-blind, placebo-controlled food challenge remains the gold standard for diagnosing food allergies, despite the need for improved standardization in its procedure to ensure accurate results and avoid unnecessary dietary restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of food allergy in children: toward a standardization of food challenge. Niggemann, B., Beyer, K.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Work Group report: oral food challenge testing. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of immediate adverse reactions to foods in adult patients. II. A detailed analysis of reaction patterns during oral food challenge. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

Safety of Low-Dose Oral Food Challenges for Hen's Eggs, Cow's Milk, and Wheat: Report from a General Hospital without Allergy Specialists in Japan. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Reaction Thresholds of Double-Blind, Placebo-Controlled Peanut and Nut Food Challenges Using Gingerbread Matrix. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Oral food challenges in children. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

[SAFETY OF A THREE-LEVEL STEPWISE ORAL FOOD CHALLENGE FOR PEANUT ALLERGY]. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Oral provocation tests (OPT) in the skin pathology of children]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Preparation of Blinded Food Matrixes for Clinical Oral Challenges. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Risk of oral food challenges. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Diagnosis of food allergy in children: toward a standardization of food challenge. [2017]