7809: Effect of Elemental Diet on Adult Patients with Eosinophilic Enteritis (ELEMENT)

Study Summary

The purpose of this study is to see if avoiding certain foods in your diet will improve your eosinophilic gastritis (EoG) or enteritis (EoN). If you take part in this study, you will be asked to complete an elemental (formula-based) diet treatment for at least 6 weeks. The elemental formula you will be drinking is an amino acid-based medical food that should not cause you to have an allergic reaction. By avoiding allergens (things that may cause allergies) in your diet, we want to see if your eosinophilic gastrointestinal disorder (EGID) gets better after at least 6 weeks of dietary treatment.

For Diseases

• Eosinophilic Gastritis
• Eosinophilic Gastroenteritis

Background

Eosinophilic Gastritis/Gastroenteritis (EoG/EoN) belong to a group of diseases that includes eosinophilic esophagitis, gastritis, enteritis, and colitis, collectively referred to as EGIDs. In individuals with EoG/EoN eosinophils, a type of white blood cell, gain access to the lining of the gastrointestinal tract and may produce symptoms such as trouble swallowing, nausea, vomiting, abdominal pain, early satiety, diarrhea, weight loss, chest pain, heartburn, regurgitation and prolonged food impaction. While treatment with elimination and elemental diets are known methods for reducing inflammation in patients with EoE, the role of food allergy in EoG/EoN has not been widely studied. The purpose of this study is to determine if avoiding food allergens will help improve EGIDs.

The research questions are:

1. Is an elemental diet an effective treatment option for adults with EoG/EoN?
2. How do EoG/EoN and the treatment for EoG/EoN affect the way a participant feels?
3. How does an elemental diet affect the clinical and histologic response in participants?
4. Can clinical and histologic markers predict treatment response?

About this Study

This is a prospective (forward-looking, observational) study of 25 individuals with EoG/EoN. Those participating in this study will be evaluated at CEGIR participating sites for at least 6 to 8 weeks. Participants between the ages of 18 and 65 that have been diagnosed with EoG/EoN will be invited to participate.

At your initial visit, you will be asked to:

• Have an endoscopy with a biopsy as part of the clinical standard of care
• Give additional gastrointestinal biopsies, stool, and saliva at the time of endoscopy for research (optional)
• Give blood
• Have a urine pregnancy test (female participants only)
• Have a physical exam and have your vital signs taken
• Meet with a dietitian to confirm your nutritional intake needs
• Fill out questionnaires to assess intake of food allergens and frequency of symptoms

After your initial visit you will be asked to:

• Drink elemental formula as your sole source of nutritional intake
• Have weekly phone calls with your dietitian
• Report your weight

After at least 6 weeks of drinking the elemental formula, you will be asked to:

• Have an endoscopy with biopsy as part of clinical standard of care
• Give additional gastrointestinal biopsies, stool, and saliva samples at the time of endoscopy for research (optional)
• Give blood
• Have a urine pregnancy test (female participants only)
• Have a physical exam and have your vital signs taken
• Complete questionnaires

Who Can Join

To be eligible to participate, you must:

• Participant must be able to understand and provide informed consent
• Males and Females ≥18 to 65 years of age
• Have a diagnosis of EoG/EoN
• Have histologically confirmed active disease ≥30 eosinophils/hpf
• Be symptomatic (have experienced symptoms within the last one month prior to enrollment).
  • Common symptoms may include:
    • abdominal pain
    • nausea
    • vomiting
    • feeling full sooner than normal or after eating less than usual
    • diarrhea
    • weight loss.
• Female participants cannot be pregnant
• Female participants must agree to use FDA approved methods of birth control for the duration of the study

You are not eligible to participate if you:

• Do not give written informed consent or follow study procedures
• Have secondary causes of gastrointestinal and peripheral eosinophilia
• Have eosinophilic infiltration only to the esophagus
• Are pregnant
• Have immunodeficiency states
• Have been treated with topical steroids within the last 6 weeks or systemic steroids within the last 2 months unless a repeat endoscopy has been performed showing active inflammation on these therapies in which case these medications will be allowed to be continued without dose escalation
• Have taken immunosuppression medication or immunomodulators within 2 months of the study unless the recent/baseline endoscopy has active histologic inflammation while on these medications. In this case, these medications will be permitted to be continued as long as the dose is not escalated during the treatment phase.
• Have been on an elemental diet previously for six weeks with follow up endoscopy completed
• Have participated in any investigative drug study within 6 weeks prior to study entry
• Are unable to complete study procedures, including endoscopy
• Have a condition called hyponatremia which is a low level of sodium in the blood
• Are at risk for fluid or electrolyte imbalances during the study. Taking high doses of diuretics, being on multiple diuretics, having clinically significant kidney insufficiency and consuming unusually high or low amounts of fluids can all put a person at risk for fluid or electrolyte imbalances.
• Have a past of current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with your ability to follow study requirements, or that may impact the quality or interpretation of the data obtained from the study.

Visit ClinicalTrials.gov to View the Study Results

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