Reference no: EM133759154

Question

Provide a script regarding the methodology: Study design and patients We performed a 2 × 2 factorial design, single-center, randomized trial with a 12-week dietary intervention for the first part of the study (2013-2015) and proceeded to conduct a randomized, double-blind, placebo-controlled trial for the second part of the study. The study consisted of a 12-week restricted diet combined with placebo or probiotics for patients (recruited from 2016 to 2019) with an IBS-D diagnosis. Patients were recruited from the gastroenterology clinic of the First Affiliated Hospital of Harbin Medical University. Although Rome IV was published in 2016, the diagnostic criteria of Rome III were applied to both parts of the study to maintain consistency. Inclusion criteria: (1) female or male 18-65 years of age; (2) IBS-D diagnosis by the Rome III criteria; and (3) positivity for food-specific serum antibody. Exclusion criteria: (1) unable to follow the research plan; (2) report of an IgE-mediated food allergy; (3) continued use of other medications, probiotics or ongoing restrictive exclusion diet; and (4) major medical conditions such as gastrointestinal surgery, diabetes, or inflammatory bowel disease. Clinical characteristics (age, gender, body mass index, smoking, and symptom duration), 3-day food diary.