An interventional study of Elemental Diet Therapy in Eosinophilic Gastroenteritis, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis
This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis
Exclusion Criteria:
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
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
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
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
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
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
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
| Milestone | Treatment |
|---|---|
| Started | 18 |
| Completed | 15 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 2 |
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))
| percentage of participants | Treatment |
|---|---|
| Percent of Participants in Complete Histologic Remission | 100 (78 to 100) |
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.
| percentage of participants | Treatment |
|---|---|
| Percent of Participants in Partial Histologic Remission | 93 (68 to 100) |
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.
| eosinophil counts per high power field | Treatment |
|---|---|
| Baseline | 63.1 (50.6 to 75.5) |
| Change | -46.9 (-59.1 to -34.7) |
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.
| score on a scale | Treatment |
|---|---|
| Baseline Endoscopic Score | 5 (4 to 5) |
| Change in Endoscopic Score | -3 (-3 to -2) |
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.
| score on a scale | Treatment |
|---|---|
| Baseline Pain | 21.8 (16.1 to 27.5) |
| Baseline Non Pain | 15.7 (13.8 to 17.7) |
| Baseline Satisfaction | 9.2 (6.1 to 12.3) |
| Change in Pain | -6.9 (-11.3 to -2.6) |
| Change in Non Pain | -1.6 (-3.1 to -0.1) |
| Change in Satisfaction | 6.1 (3.7 to 8.6) |
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.
| T-score | Treatment |
|---|---|
| Baseline Anxiety | 52.6 (47.2 to 58.0) |
| Change in Anxiety | -2.7 (-7.0 to 1.6) |
Collected over From informed consent to cessation of treatment which is approximately 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/18 (0%) | 1/18 (5.6%) | 4/18 (22.2%) |
| Event | Treatment |
|---|---|
| HyponatremiaMetabolism and nutrition disorders | 1/18 |
| Event | Treatment |
|---|---|
| NauseaGastrointestinal disorders | 1/18 |
| VomitingGastrointestinal disorders | 1/18 |
| Urinary Tract InfectionInfections and infestations | 1/18 |
| Common ColdGeneral disorders | 1/18 |
| Skin lacerationInjury, poisoning and procedural complications | 1/18 |
| UrticariaSkin and subcutaneous tissue disorders | 1/18 |
| SyncopeNervous system disorders | 1/18 |
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 37.8 ± 12.5 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 10 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Treatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
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Children's Hospital Medical Center, Cincinnati