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Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320369
Recruitment Status : Completed
First Posted : October 25, 2017
Results First Posted : September 28, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Rare Diseases (ORD)
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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

Condition or disease Intervention/treatment Phase
Eosinophilic Gastroenteritis Other: Elemental Diet Therapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : October 5, 2019


Arm Intervention/treatment
Treatment
Elemental formula Intervention: Elemental Diet Therapy
Other: Elemental Diet Therapy
Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320369


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Rare Diseases (ORD)
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Nirmala Gonsalves, M.D. Northwestern University
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Study Protocol  [PDF] September 10, 2019
Statistical Analysis Plan  [PDF] May 1, 2020

Additional Information:
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03320369    
Other Study ID Numbers: 2017-2766
U54AI117804 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2017    Key Record Dates
Results First Posted: September 28, 2020
Last Update Posted: October 27, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastroenteritis
Eosinophilic Esophagitis
Enteritis
Gastritis
Eosinophilia
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Esophageal Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Intestinal Diseases
Stomach Diseases