Trial Outcomes & Findings for Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis (NCT NCT03320369)

NCT ID: NCT03320369

Last Updated: 2020-10-27

Results Overview

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))

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 6 weeks after treatment
• Results posted on: 2020-10-27

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Baseline characteristics by cohort

Measure	Treatment n=18 Participants 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
Age, Continuous	37.8 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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))

Outcome measures

Measure	Treatment n=15 Participants 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
Percent of Participants in Complete Histologic Remission	100 percentage of participants Interval 78.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=15 Participants 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
Percent of Participants in Partial Histologic Remission	93 percentage of participants Interval 68.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=15 Participants 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
Mean Change From Baseline in Maximum Eosinophil Count Baseline	63.1 eosinophil counts per high power field Interval 50.6 to 75.5
Mean Change From Baseline in Maximum Eosinophil Count Change	-46.9 eosinophil counts per high power field Interval -59.1 to -34.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=15 Participants 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
Change From Baseline in Total Gastric Endoscopic Reference Score Baseline Endoscopic Score	5 score on a scale Interval 4.0 to 5.0
Change From Baseline in Total Gastric Endoscopic Reference Score Change in Endoscopic Score	-3 score on a scale Interval -3.0 to -2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=15 Participants 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
Change From Baseline in Symptoms of Dyspepsia (SODA) Baseline Pain	21.8 score on a scale Interval 16.1 to 27.5
Change From Baseline in Symptoms of Dyspepsia (SODA) Baseline Non Pain	15.7 score on a scale Interval 13.8 to 17.7
Change From Baseline in Symptoms of Dyspepsia (SODA) Baseline Satisfaction	9.2 score on a scale Interval 6.1 to 12.3
Change From Baseline in Symptoms of Dyspepsia (SODA) Change in Pain	-6.9 score on a scale Interval -11.3 to -2.6
Change From Baseline in Symptoms of Dyspepsia (SODA) Change in Non Pain	-1.6 score on a scale Interval -3.1 to -0.1
Change From Baseline in Symptoms of Dyspepsia (SODA) Change in Satisfaction	6.1 score on a scale Interval 3.7 to 8.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=15 Participants 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
Change From Baseline in Promis Anxiety Baseline Anxiety	52.6 T-score Interval 47.2 to 58.0
Change From Baseline in Promis Anxiety Change in Anxiety	-2.7 T-score Interval -7.0 to 1.6

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=18 participants at risk 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
Metabolism and nutrition disorders Hyponatremia	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks

Other adverse events

Measure	Treatment n=18 participants at risk 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
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks
Infections and infestations Urinary Tract Infection	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks
General disorders Common Cold	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks
Injury, poisoning and procedural complications Skin laceration	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks
Skin and subcutaneous tissue disorders Urticaria	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • From informed consent to cessation of treatment which is approximately 8 weeks

Additional Information

Nirmala Gonsalves

Northwestern University

Phone: 312-695-4054

Email: n-gonzalves@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place