Allergy and Immunology

Study for Children, Teens and Adults 12 to 60 Years Old with Eosinophilic Gastritis

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to test the effectiveness of a drug called Benralizumab in people diagnosed with Eosinophilic Gastritis (EG). Benralizumab is approved by the FDA for treatment of adolescents and adults with eosinophilic asthma but not other types of eosinophilic diseases.

Who can participate?

Children, teens and adults 12 to 60 years old with EG or with Eosinophilic Gastroenteritis (EGE) may be eligible to participate. EG and EGE are inflammatory diseases involving a combination of gastrointestinal locations including the esophagus, stomach, and small intestine. Involvement of the stomach (EG) is required to participate.

What will happen in the study?

There are three phases to the study. Each phase involve visits to Cincinnati Children’s Hospital Medical Center (CCHMC).

Screening phase: Involves one visit. The screening phase is to make sure you are eligible to take part in the study. It will involve an endoscopy to determine how your EG is doing.

Treatment phase: Involves four visits. You will be assigned by chance (like the flip of a coin) to receive Benralizumab or placebo. A placebo is an inactive substance. Neither you nor your study doctor will know whether you are receiving study drug (Benralizumab) or placebo. In the case of an emergency, you and your doctor will be able to know if you have been on drug or placebo. The study drug will be given as a subcutaneous injection (an injection under the skin) once every 4 weeks for 2 months (3 total injections). An endoscopy will be done at the end of this treatment phase.

Open Label phase: Upon completion of the treatment phase, you may choose to participate in the Open Label extension phase, in which you will receive treatment with Benralizumab for an additional 24 weeks. Open Label means that there is no placebo; all participants will receive the active drug in this part of the study. There are seven visits in the Open Label phase. The first visit will include an endoscopy at CCHMC and an injection of the study drug. Three additional visits will occur at CCHMC where you will receive the study drug. Two other visits will occur over the phone. The final visit will take place at CCHMC and will include an endoscopy.

Will I need to change my diet or other medications during the study?

Throughout the study you should follow the same diet that you were following before starting the study. You may continue to take the medications that you were taking before starting the study, but try not to take any new medications or change the dose of the medications that you are taking, if possible. If there are changes to your diet or medication at any time, you should contact a study staff member.

What are the good things that can happen from this research?

We hope to learn that the study drug Benralizumb is an effective treatment for EG and EGE. It has already been determined to be effective in the treatment of eosinophilic asthma.

What are the bad things that can happen from this research?

Possible risks and discomforts will be discussed with parents or guardians interested in learning more about the study.

Will you/your child be paid to be in this research study?

You will be paid for your time and travel expenses incurred throughout the study. You will receive $50 for each study visit including visits that take place over the phone. You will receive $100 for the visit that occurs at the end of the treatment phase. The total for completion of all study visits is $600. If the doctor requests any additional visits, you will be paid $50 for each of them. Additional compensation for travel is available to partially cover expenses for hotels and/or airfare.

Who should I contact for more information?

Tal Cohen 513-517-1074 tal.cohen@cchmc.org Cincinnati Center for Eosinophilic Disorders The Division of Allergy and Immunology Cincinnati Children’s Hospital Medical Center 3333 Burnet Ave. Cincinnati, OH 45229-3039

Study Doctor:

Marc Rothenberg MD Cincinnati Children’s Hospital Medical Center  

Where can I find additional information?

ClinicalTrials.gov 

Peanut Allergies: Adults 18 to 55 Years Old
Investigational Peanut Vaccine Study Drug Research Study 

What 
We want to learn more about the safety and tolerability of an investigational peanut vaccine study drug for adults with non-severe peanut allergies. We want to see if the peanut vaccine study drug will train the immune system not to have an allergic reaction when the body comes in contact with peanut proteins. 
 
Who 
Adults, 18 to 55 years old, with a physician-diagnosed, non-severe peanut allergy or a history of peanut allergy, may be eligible to participate. 
 
What’s Involved 
The study has up to 13 visits over a period of 8 1/2 months. Participants will have 6 weeks of study drug treatment (and receive either 4 doses of vaccine study drug or placebo, which contains no active ingredient) and 6 months of follow-up. 
 
Pay 
Participants will receive up to $1300 for their time and travel. 
 
Contact 
For more information, please email jennifer.jennings2@cchmc.org or call 1-513-636-7085.  
 
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Cincinnati Children’s Peanut Vaccine Study (ages 18-55)

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 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?

Amy Tasco, 513 517-2108, amy.tasco@cchmc.org

Where can I find additional information?

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

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?

Kara Kliewer, 513-636-4821, Kara.Kliewer@cchmc.org

Where can I find additional information?

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

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

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 ccedresearch@cchmc.org

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Eosinophilic Esophagitis Medication Study (PDF)

Needed: 4 to 55 Year Olds with Multiple Food Allergies

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.

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Cincinnati Children's Multiple Food Allergies Study (ages 4-55) (PDF)

Needed: 4 to 26 Year Olds with a Peanut Allergy

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.

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Cincinnati Children's Peanut Allergy Study (ages 4-26) (PDF)

Do You or a Loved One Have a Peanut Allergy?

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

Read More

Cincinnati Children's Peanut Allergy Study (ages 6-55) (PDF)

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

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:

AND

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

Investigational Asthma Medication Research Study

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

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Cincinnati Children's Moderate to Severe Asthma Study 

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

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.

Read More

Cincinnati Children's Severe Asthma Medication Research Study (PDF)