Effect of amino acid-based formula added to four-food elimination in adult eosinophilic esophagitis patients: A randomized clinical trial

Abstract

Background: Elimination of key foods restricts dietary options in eosinophilic esophagitis (EoE) patients. Addition of amino acid-based formula (AAF) to an elimination diet might facilitate adherence and, therefore, enhance efficacy of dietary management.

Aim: To evaluate whether addition of AAF to a four-food elimination diet (FFED) is more effective than FFED alone in decreasing eosinophilia, endoscopic signs, and clinical outcomes.

Methods: This randomized controlled trial enrolled 41 adult patients with active EoE (≥15 eosinophils (eos) per high power field (hpf)) at baseline biopsy. Subjects were randomized (1:1 ratio) to groups given a FFED or FFED with addition of AAF providing 30% of their daily energy needs (FFED + AAF). Histological disease activity, endoscopic signs, symptoms, and disease-related quality of life (EoEQoL) were measured at baseline and after 6 weeks of intervention.

Results: Patients (60% male, age 34.5 (interquartile range (IQR) 29-42.8 years)) were randomized to FFED (n = 20) or FFED + AAF (n = 21); 40 participants completed the diet. Complete histological remission (<15 eos/hpf) was achieved in 48% of FFED + AAF subjects (n = 21) vs. 25% of FFED subjects (n = 20), respectively (p = 0.204). Peak eosinophil counts (PEC) decreased significantly in both groups between baseline and week 6, but the change in PEC between groups was not different (p = 0.130). A significant but similar endoscopic and symptomatic reduction was observed in both groups (all; p<0.05). Total EoEQoL scores significantly improved in the FFED + AAF group between baseline and week 6 (p = 0.007), and not in the FFED group.

Conclusion: The addition of AAF to a FFED did not lead to a larger decrease in PEC between baseline and 6 weeks, but may result in a significant improvement of QoL in adult EoE patients NL6014 (NTR6778).

Keywords: elemental diet; elimination diet; eosinophilic esophagitis; esophageal eosinophilia and allergy; quality of life.

FIGURE 1

| Flow chart demonstrating the number of patients who were eligible for participation, randomization, and ITT analysis. In addition, all patients who discontinued the trial or were switched to the FFED group for final PP analyses are presented. FFED, Four‐food elimination diet; ITT, Intention to treat; PP, Per protocol

FIGURE 2

| Histological outcome measures (ITT cohort): (A) peak eosinophil count (eos/hpf) pre‐/post‐treatment and between groups; and (B) post‐treatment proportion (%) of patients in complete‐/partial‐/no histological remission between groups. Complete histological remission = Rate of patients with complete histological remission at week 6 (<15 eos/hpf), partial histological remission = Rate of patients with partial histological remission at week 6 (≥50% reduction in pre‐treatment eos/hpf), and no histological remission = Rate of patients with no histological remission at week 6., eos, Eosinophils; hpf, High power field; ITT, Intention to treat

FIGURE 3

| Endoscopic and Symptom outcome measures (ITT‐cohort): (A) EREFS pre‐/post‐treatment and between groups; (B) SDI‐PRO measure score pre‐/post‐treatment and between groups; and (C) EoEQoL pre‐/post‐treatment and between groups. EREFS, Endoscopic Reference score; ITT, Intention to treat; SDI, Straumann Dysphagia Instrument