Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

NCT03320369 | Completed Results

• 2 other identifiers: 2017-2766U54AI117804
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eosinophilic Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Percent of Participants in Complete Histologic Remission

  Percent of patients who have achieved complete histologic remission. Complete histologic remission is defined as normalization of gastric mucosal eosinophilia (histology with less than the diagnostic threshold levels of mucosal eosinophilia (\<30 eosinophils per high power field (HPF))

  6 weeks after treatment

Secondary Outcomes (5)

• Percent of Participants in Partial Histologic Remission

  6 weeks after treatment

• Mean Change From Baseline in Maximum Eosinophil Count

  Baseline, 6 weeks after treatment

• Change From Baseline in Total Gastric Endoscopic Reference Score

  Baseline, 6 weeks after treatment

• Change From Baseline in Symptoms of Dyspepsia (SODA)

  Baseline, 6 weeks after treatment

• Change From Baseline in Promis Anxiety

  Baseline, 6 weeks after treatment

Study Arms (1)

Treatment

OTHER

Elemental formula Intervention: Elemental Diet Therapy

Other: Elemental Diet Therapy

Interventions

Elemental Diet Therapy OTHER

Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be able to understand and provide informed consent
• Males and Females ≥18 to 65 years of age;
• Have diagnosis of EG/EGE
• Have histologically confirmed active disease \> 30 eosinophils/hpf
• Symptomatic (have experienced symptoms within the last one months prior to enrollment).
• Female subjects of childbearing potential must have a negative pregnancy test upon study entry
• 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

You may not qualify if:

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• Secondary causes of gastrointestinal and peripheral eosinophilia
• Eosinophilic infiltration isolated to the esophagus.
• Pregnancy
• Immunodeficiency states
• 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.
• 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.
• Unable to complete study procedures including endoscopy.
• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Office of Rare Diseases (ORD): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60208, United States

Location

Related Publications (1)

• Gonsalves N, Doerfler B, Zalewski A, Yang GY, Martin LJ, Zhang X, Shoda T, Brusilovsky M, Aceves S, Thompson K, Rudman Spergel AK, Furuta G, Rothenberg ME, Hirano I. Prospective study of an amino acid-based elemental diet in an eosinophilic gastritis and gastroenteritis nutrition trial. J Allergy Clin Immunol. 2023 Sep;152(3):676-688. doi: 10.1016/j.jaci.2023.05.024. Epub 2023 Jul 18.

  PMID: 37462600 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Eosinophilic enteropathy

Results Point of Contact

• Title: Nirmala Gonsalves
• Organization: Northwestern University

n-gonzalves@northwestern.edu

312-695-4054

Study Officials

• Nirmala Gonsalves, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 25, 2017
• Study Start: September 5, 2017
• Primary Completion: September 5, 2019
• Study Completion: October 5, 2019
• Last Updated: October 27, 2020
• Results First Posted: September 28, 2020

Record last verified: 2020-09

Locations

US (1)