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Completed

NCT Number: NCT03320369

Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

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

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Key information

Conditions

Eosinophilic Gastroenteritis Eosinophilic enteropathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60208, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Elemental Diet Therapy

Other

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

Primary outcomes

  1. Percent of Participants in Complete Histologic Remission

    Time frame: 6 weeks after treatment

    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))

Secondary outcomes

  1. Percent of Participants in Partial Histologic Remission

    Time frame: 6 weeks after treatment

    Percent of participants in partial histologic remission. Partial remission is defined as 50% or more reduction in the maximum of gastric and duodenal peak eosinophil count.

  2. Mean Change From Baseline in Maximum Eosinophil Count

    Time frame: Baseline, 6 weeks after treatment

    The maximum between gastric and duodenal eosinophil counts per high power field were obtained at baseline and 6 weeks. Mean change in count is defined as maximum eosinophil count per high power field (hpf) at 6 weeks minus maximum eosinophil count per hpf at baseline. A reduction (negative change from baseline) in eosinophil count per hpf indicates improvement. Eosinophil counts per hpf from gastric and duodenal biopsies were assessed by research pathologists at 400X magnification.

  3. Change From Baseline in Total Gastric Endoscopic Reference Score

    Time frame: Baseline, 6 weeks after treatment

    The gastric endoscopic reference score utilizes standardized criteria for the presence and degree of major endoscopic features. Overall scores range from 0 - 10. Endoscopic features were assessed at baseline and 6 weeks. Change in overall endoscopic reference score is defined as overall score at 6 weeks minus overall score at baseline. A reduction (negative change) in score indicates improvement.

  4. Change From Baseline in Symptoms of Dyspepsia (SODA)

    Time frame: Baseline, 6 weeks after treatment

    The SODA questionnaire captures symptoms associated with gastric dyspepsia including symptoms associated with "pain" and "non-pain" as well as general satisfaction with present symptoms. The scores range from 0 to 47 for pain; 0 to 35 for non-pain, and 0 to 23 for satisfaction. Higher scores indicate more frequent and/or severe symptoms for pain and non-pain. Higher scores indicate greater satisfaction. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline. A reduction (negative change) indicates improvement in pain and non-pain. An increase (positive change) indicates improvement in satisfaction.

  5. Change From Baseline in Promis Anxiety

    Time frame: Baseline, 6 weeks after treatment

    The Promis 29 questionnaire was used to assess anxiety. The range of scores for the anxiety sub-domain is 4 - 20 (raw score) with T-scores ranging from 40 to 82. A higher T-score indicates greater anxiety. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Office of Rare Diseases (ORD)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2017
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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