*Effect of addition of elemental nutrition to an elimination diet on esophageal inflammation in adult eosinophilic esophagitis (EoE) patients: A randomized controlled trial

*Effect of addition of elemental nutrition to an elimination diet on esophageal inflammation in adult eosinophilic esophagitis (EoE) patients: A randomized controlled trial - Supplemental Elemental trial (SET)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48882

Enrollment

Registered

2017-10-10

Start date

2017-11-29

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic esophagitis Idiopathic eosinophilic esophagitis

Interventions

Standard elimination diet or elimination diet with addition of elemental nutrition.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Active EoE at baseline i.e. presence of >15 eosinophilic granulocytes per high power field (HPF) in mid or proximal esophageal biopsies before the start of any therapy - Currently experiencing dysphagia - Written informed consent - Age above 18 years

Exclusion criteria

Exclusion criteria: Patients: - Inability to stop topical corticosteroids - Use of systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the month preceding the study - Use of anticoagulants at study entry - Recent history of GI cancer - History of major GI tract surgery - ASA class IV or V

Design outcomes

Primary

Measure	Time frame
Change in peak eosinophil count, measured as maximum number of eosinophils per HPF. Response is defined as complete if the reduction of absolute number of eosinophils per HPF is decreased to	—

Secondary

Measure	Time frame
Clinical / endoscopic parameters: - Questionnaires: o o Patient acceptation of and adherence to the diet will be checked by means of an appointment at the dietitian after 2 and 4 weeks to evaluate the diet. Feasibility of the diet will be measured using the likert scoring system. o Patient reported symptoms (Reflux Disease Questionnaire (RDQ), and Straumann Dysphagia Index (SDI))) (baseline and after diet) o Quality of life (EoE-QoL-A) (baseline and after diet) o Esophageal endoscopic signs measured with the Endoscopic Reference Score (EREFS) - Nutritional monitoring: o Body Mass Index (BMI) to measure weight loss o Nutrition intake will be calculated at baseline and after 4 weeks of elimination diet using 3-day food diaries Laboratory investigations: - Expression of genes encoding for the esophageal inflammation and barrier function (IL-1, IL-4, IL-6, IL-8, IL10, IL12, IL-13, IL-15, Thymic Stromal Lymphopoietin (TSLP), Eotaxin (CCL26), desmoglein-1 (DSG1) and filaggrin (FLG)) - Immunohistochemical analyses of esophageal material to assess expression and localization of proteins involved in barrier function. - Transcriptional analyses: microarray or focused qPCR. Genes to be analyzed by qPCR involve: o Activity markers of EoE (IL-5, IL-13, eotaxin-3, TSLP) o Barrier integrity proteins (filaggrin, desmoglein)	—

Measure

Time frame

Clinical / endoscopic parameters: - Questionnaires: o o Patient acceptation of and adherence to the diet will be checked by means of an appointment at the dietitian after 2 and 4 weeks to evaluate the diet. Feasibility of the diet will be measured using the likert scoring system. o Patient reported symptoms (Reflux Disease Questionnaire (RDQ), and Straumann Dysphagia Index (SDI))) (baseline and after diet) o Quality of life (EoE-QoL-A) (baseline and after diet) o Esophageal endoscopic signs measured with the Endoscopic Reference Score (EREFS) - Nutritional monitoring: o Body Mass Index (BMI) to measure weight loss o Nutrition intake will be calculated at baseline and after 4 weeks of elimination diet using 3-day food diaries Laboratory investigations: - Expression of genes encoding for the esophageal inflammation and barrier function (IL-1, IL-4, IL-6, IL-8, IL10, IL12, IL-13, IL-15, Thymic Stromal Lymphopoietin (TSLP), Eotaxin (CCL26), desmoglein-1 (DSG1) and filaggrin (FLG)) - Immunohistochemical analyses of esophageal material to assess expression and localization of proteins involved in barrier function. - Transcriptional analyses: microarray or focused qPCR. Genes to be analyzed by qPCR involve: o Activity markers of EoE (IL-5, IL-13, eotaxin-3, TSLP) o Barrier integrity proteins (filaggrin, desmoglein)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)