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CEGIR 7809: Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Study Purpose

The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participant must be able to understand and provide informed consent 2. Males and Females ≥18 to 65 years of age; 3. Have diagnosis of EG/EGE 4. Have histologically confirmed active disease > 30 eosinophils/hpf 5. Symptomatic (have experienced symptoms within the last one months prior to enrollment). 6. Female subjects of childbearing potential must have a negative pregnancy test upon study entry 7. Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study-specific methods may be listed, if applicable

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol 2. Secondary causes of gastrointestinal and peripheral eosinophilia 3. Eosinophilic infiltration isolated to the esophagus. 4. Pregnancy 5. Immunodeficiency states 6. Have been treated with topical swallowed steroids within the last 6 weeks or systemic steroids within the last 2 months unless repeat endoscopy is performed and shows active inflammation on these therapies in which case these medications will be allowed to be continued without dose escalation. 7. 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. 8. Have been on an elemental diet previously for six weeks with follow up endoscopy completed. 9. Have participated in any investigative drug study within 6 weeks prior to study entry. 10. Unable to complete study procedures including endoscopy. 11. Past or 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 the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03320369
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Medical Center, Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nirmala Gonsalves, M.D.
Principal Investigator Affiliation Northwestern University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIHNIHNIHNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Gastroenteritis
Study Website: View Trial Website
Additional Details

This prospective interventional study will investigate the effect of a six week elemental diet in adult patients with Eosinophilic Gastroenteritis

Arms & Interventions

Arms

Other: Treatment

Treatment Phase will evaluate the effectiveness of elemental diet Intervention: Elemental Diet Therapy

Interventions

Other: - elemental diet therapy

elemental formula

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60208

Site Contact

Angelika Zalewski

angelika.zalewski@northwestern.edu

312-695-4054

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