Allergy and Immunology

Allergy and Immunology Clinical Trials

We at the Division of Allergy and Immunology at Cincinnati Children’s are devoted to providing the best care for our patients. Our dedicated clinical staff partner with families to improve the health and quality of life of our patients. Our involvement in human research studies, also known as clinical trials, helps us to determine what treatments and strategies work best for our patients. Our division’s clinical trials team is dedicated to bringing cutting-edge therapies to our child and adult patients.

Ongoing Clinical Trials

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CEGIR Contact Registry (Open Enrollment)

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CEGIR Contact Registry

Have you been searching for the latest research studies for Eosinophilic Gastrointestinal Disease (EGID)?

Join the Rare Diseases Clinical Research Network (RDCRN) Contact Registry today!

Have you or your child been diagnosed with EGID?

Eosinophilic Esophagitis (EoE)
Eosinophilic Gastritis (EG)
Eosinophilic Colitis (EC)

If so, you are invited to sign up for the Rare Diseases Clinical Research Network (RDCRN) Contact Registry.

What is the RDCRN Contact Registry?

The RDCRN Contact Registry is a way that patients with rare disorders, like EGID, can receive information about new research studies, eligibility for participation in clinical studies/trials, and updates on results of such studies.

Why Join the RDCRN Contact Registry?

Patients who participate in research make it possible for researchers to find new treatments, create new studies, and work for the improvement of all EGID patients. It can also help connect you with Patient Advocacy Groups (PAGs).

Find out more about the RDCRN Contact Registry, or join the registry.

CEGIR OMEGA Study (Open Enrollment)

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CEGIR OMEGA Study for Patients with Eosinophilic Esophagitis (EoE), Eosinophilic Gastritis (EG), and Eosinophilic Colitis (EC)

What is the purpose of this study?

The purpose of this observational research study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EG, and EC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.

Who can participate?

Children and adults ages 3-65 years that have been diagnosed with EoE, EG, or EC.

Details

General CEGIR OMEGA Description (PDF)
Adult (18-65 years) CEGIR OMEGA (PDF)
Pediatric (3-17 years) CEGIR OMEGA (PDF)

Who should I contact for more information?

Jonathan Kuhl, BS, 513-803-3078, Jonathan.kuhl@cchmc.org

Where can I find additional information?

https://www.rarediseasesnetwork.org/cms/CEGIR

CEGIR SOFEED Study (Open Enrollment)

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SOFEED Study for Patients with Eosinophilic Esophagitis (EoE)

What is the purpose of this study?

The purpose of this research study is to test the effects of two elimination dietary therapies—the 1 Food Elimination Diet (1FED) (Milk) vs. the 6 Food Elimination Diet (6FED) (Milk, Egg, Wheat, Soy, Peanut/tree nuts, and fish/shellfish) in patients diagnosed with EoE. This study also aims to test participant’s response to swallowed glucocorticoids (Flovent) in participants who do not respond to the 6-Food elimination diet. Flovent is a topical steroid (taken using an inhaler) approved by the FDA to treat asthma, but that is also used for patients with EoE.

Who can participate?

Adults ages 18-60 years that have been diagnosed with EoE.

Details

SOFEED Study (PDF)

Who should I contact for more information?

Jonathan Kuhl, BS, 513-803-3078, Jonathan.kuhl@cchmc.org

Where can I find additional information?

https://www.rarediseasesnetwork.org/cms/CEGIR

EoE Medication Study (Open Enrollment)

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Testing the Effectiveness of Losartan in Participants With EoE, With or Without a Connective Tissue Disorder

CCHMC IRB # 2012-0106: V2

The Cincinnati Center for Eosinophilic Disorders is conducting a research study to test whether losartan decreases the number of eosinophils in the esophagus of participants with active EoE, with or without a connective tissue disorder (CTD).

What

We are enrolling participants for a 4 month open label drug trial. This involves several visits to Cincinnati Children’s, blood draws, biopsies taken from EGD, and having vitals taken.

How

Participation will take place at Cincinnati Children’s, over the phone and through the mail.

Who

People with active EoE with or without a CTD

Contact

If you have questions or are interested in participating, contact Jonathan Kuhl at Jonathan.Kuhl@cchmc.org or 513-803-3078.

Needed: 4 to 55 Year Olds with Multiple Food Allergies

CCHMC IRB #2014-2318:V1

What

We want to learn if a drug, called omalizumab, will help children and adults with multiple food allergies be able to safely ingest the foods they are allergic to.

Omalizumab is investigational because the U.S. Food and Drug Administration (FDA) has not yet approved it for the treatment of food allergies in children and adults. It is approved for the treatment of asthma in children and adults, 12 and above.

Who

Children, teens and adults, 4 to 55 years old, who have 2 or more food allergies, may be eligible to participate. Food allergies include: peanut, milk, egg, wheat, soy, sesame seed, fish, shellfish and/or certain tree nuts (almond, cashew, walnut, hazelnut, pecan).

Anyone with an oat allergy, moderate or severe persistent asthma, and/or eosinophilic disorders will not be able to participate.

Pay

Participants may receive from $20 to $40 per visit for their time and travel.

Contact

Lisa Thornbury Clark at 513-803-3663 or foodstudies@cchmc.org.

Needed: 4 to 26 Year Olds with a Peanut Allergy

CCHMC IRB #2013-6150:V1

What

We want to find out if there is a way to help lower the risk of severe allergic reactions for children and adults with an allergy to peanuts.

Who

Children, teens and adults, 4 to 26 years old, who have a documented history of peanut allergy may be eligible to participate.

Pay

Participants may receive $50 per completed study visit for their time and travel.

Details

For more information, please contact foodstudies@cchmc.org or 513-803-FOOD.

Do You or a Loved One Have a Peanut Allergy?

CCHMC IRB #2012-1498:V1

Needed

6 to 55 Year Olds for Peanut Allergy Medication Research Study

What

This is a research study to evaluate the safety and effectiveness of the investigational medication Viaskin® Peanut for treating peanut allergy in children and adults.

Why

To date, there is no specific approved treatment for peanut allergy, which can be quite severe and life-threatening. The only management recommended for patients allergic to peanuts is strict avoidance. However, peanut is a very common ingredient in many foods and is not always reported in all ingredients.

Who

Children and adults 6 to 55 years old who have a well-documented history of peanut allergy and are currently following a strict peanut-free diet may be eligible to participate.

Compensation

Participants may receive up to $480 for travel related expenses for completing all 12 study visits ($40 per completed study visit).

Details

For more information, please email foodstudies@cchmc.org or call 1-513-803-FOOD

Recently Completed Clinical Trials

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Asthma Medication Research Study

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Do You or Your Child Have Asthma? Do You or Your Child Take an Oral Steroid Every Day for that Asthma?

CCHMC IRB #2012-2698:V1

What

This is a research study to learn more about the safety and effectiveness of a drug called mepolizumab in treating asthma. Researchers want to know if mepolizumab can lower the amount of oral steroids a person needs to take to treat their asthma.

Who

Children, teens and adults 12 years old and older who:

Have asthma

AND

Take steroid medicine by mouth (orally) every day to treat their asthma

Pay

Participants may be paid up to $465 for completing all study visits.

Details

For more information, please contact Erin Brockman at erin.brockman@cchmc.org or 513-636-7897.

Are You An Adult with Asthma?
Do You Still Use an Inhaler?

Investigational Asthma Medication Research Study

CCHMC IRB #2012-1422:V1

What

The purpose of this research study is to evaluate the safety and effectiveness of an investigational medication. The study will examine whether this medication is beneficial in improving lung function in patients with moderate to severe asthma and compare its effectiveness among certain types of patients.

Who

Adults 18 to 75 years old who:

Have been diagnosed with moderate or severe asthma
Are on an inhaled corticosteroid (like Flovent, Advair, etc.)

Pay

Participants may receive compensation for their travel and time.

Details

For more information, please email asthmastudies@cchmc.org or call 1-513-636-AZMA

Needed: Children, Teens and Adults 12 Years or Older Who Have Severe Asthma

CCHMC IRB #2012-2702:V1

What

This is a research study to learn more about the safety and effectiveness of a new drug, called mepolizumab, in treating asthma.

Researchers also want to know how the body reacts to the drug and if there is a change in the number of asthma attacks a person has while taking mepolizumab.

Who

Children, teens and adults 12 years old and older who been diagnosed with asthma AND:

Have been using a steroid inhaler for 12 months
Have been in the hospital or emergency room at least 2 times because of their asthma

Pay

Participants may receive compensation for their travel and time.

Details

For more information, contact Erin Brockman at erin.brockman@cchmc.org or 513-636-7897.

Allergy and Immunology