This is a quadruple-blinded trial. In addition to the subjects, the research investigators (AH, HS), outcome assessor (AH), and independent statistician (data analyst) will be blinded until the completion of the data analysis. The participants and their caregivers will be not informed about the characteristics of the diet being consumed (the name and description will not be provided, as in similar previous RCTs [28, 29]). The researcher will encourage the caregivers/participants not to attempt to identify the nature of the provided diet using available data sources; however, an associated bias cannot be excluded. Therefore, after completion of the follow-up period, each participant and outcome assessor will be asked whether he/she believes that active treatment was administered (these data will be published with the final results, as recommended) [15]. The dietitian (AS) will remain unblinded. The procedure was established to maintain separation between the dietitian and outcome assessor and analysts. The primary outcome will be assessed by a blinded researcher (AH). If possible, to increase the similarity of diets in the two groups, low-FODMAP substitutes will be provided in place of high-FODMAP products in the meal plans.

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