Dietary Intervention Trial Design in Patients With an Ileoanal Pouch: Lessons From a Randomized, Double-Blind, Placebo-Controlled Feeding Study

回肠肛管吻合术患者的饮食干预试验设计:一项随机、双盲、安慰剂对照喂养研究的经验教训

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Abstract

PURPOSE: The aims of this study were to assess the effects of a whole diet strategy, a Monash Pouch Diet (MPD), on pouch-related symptoms, inflammation, quality of life, and stool characteristics in a cohort of patients with symptomatic pouches and a history of pouchitis compared with a typical Australian pouch diet. METHODS: In this randomized, double-blind, placebo-controlled dietary feeding trial, patients with ileoanal pouches received either a Monash Pouch diet or a typical Australian diet for 7 weeks. Clinical scores (Pouch Disease Activity Index, PDAI), pouch symptoms, tolerability, fecal calprotectin, and quality of life were measured pre- and post-intervention. The primary outcome consisted of the proportion of patients achieving symptomatic remission (clinical PDAI ≤ 2). RESULTS: All patients on the MPD experienced worsening symptoms, and the trial was terminated early. The majority of the participants reported partial adherence (50%-80%) and poor tolerability (median: 40 mm). Quality of life outcomes were highly variable across dietary arms, and fecal indices showed no consistent trends related to diet. CONCLUSION: This double-blinded, placebo-controlled, dietary feeding trial failed to determine the effect of the Monash Pouch Diet on pouchitis but suggests that the design of dietary trials for pouch patients requires careful consideration.

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