Eosinophilic Gastroenteritis
Conditions
Brief summary
The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis
Detailed description
This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis
Interventions
OTHERElemental Diet Therapy
Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete
Sponsors
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 Sciences (NCATS)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants in Complete Histologic Remission | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants in Partial Histologic Remission | 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. |
| Mean Change From Baseline in Maximum Eosinophil Count | 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. |
| Change From Baseline in Total Gastric Endoscopic Reference Score | 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. |
| Change From Baseline in Symptoms of Dyspepsia (SODA) | 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. |
| Change From Baseline in Promis Anxiety | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Elemental formula Intervention: Elemental Diet Therapy
Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 4 / 18 |
| serious Total, serious adverse events | 1 / 18 |
Outcome results
Primary
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))
Time frame: 6 weeks after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percent of Participants in Complete Histologic Remission | 100 percentage of participants |
Secondary
Change From Baseline in Promis Anxiety
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.
Time frame: Baseline, 6 weeks after treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment | Change From Baseline in Promis Anxiety | Baseline Anxiety | 52.6 T-score |
| Treatment | Change From Baseline in Promis Anxiety | Change in Anxiety | -2.7 T-score |
Secondary
Change From Baseline in Symptoms of Dyspepsia (SODA)
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.
Time frame: Baseline, 6 weeks after treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment | Change From Baseline in Symptoms of Dyspepsia (SODA) | Baseline Pain | 21.8 score on a scale |
| Treatment | Change From Baseline in Symptoms of Dyspepsia (SODA) | Baseline Non Pain | 15.7 score on a scale |
| Treatment | Change From Baseline in Symptoms of Dyspepsia (SODA) | Baseline Satisfaction | 9.2 score on a scale |
| Treatment | Change From Baseline in Symptoms of Dyspepsia (SODA) | Change in Pain | -6.9 score on a scale |
| Treatment | Change From Baseline in Symptoms of Dyspepsia (SODA) | Change in Non Pain | -1.6 score on a scale |
| Treatment | Change From Baseline in Symptoms of Dyspepsia (SODA) | Change in Satisfaction | 6.1 score on a scale |
Secondary
Change From Baseline in Total Gastric Endoscopic Reference Score
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.
Time frame: Baseline, 6 weeks after treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment | Change From Baseline in Total Gastric Endoscopic Reference Score | Baseline Endoscopic Score | 5 score on a scale |
| Treatment | Change From Baseline in Total Gastric Endoscopic Reference Score | Change in Endoscopic Score | -3 score on a scale |
Secondary
Mean Change From Baseline in Maximum Eosinophil Count
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.
Time frame: Baseline, 6 weeks after treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment | Mean Change From Baseline in Maximum Eosinophil Count | Baseline | 63.1 eosinophil counts per high power field |
| Treatment | Mean Change From Baseline in Maximum Eosinophil Count | Change | -46.9 eosinophil counts per high power field |
p-value: <0.001t-test, 2 sided
Secondary
Percent of Participants in Partial Histologic Remission
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.
Time frame: 6 weeks after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percent of Participants in Partial Histologic Remission | 93 percentage of participants |