Digestive Enzyme Powder Study for Irritable Bowel Syndrome Patients Who Responded to a Mediterranean Low FODMAP Diet

What this Trial Is About

Irritable bowel syndrome (IBS) is a common chronic digestive disorder causing symptoms like abdominal pain, bloating, and changes in bowel habits without clear structural causes. This research evaluates a digestive enzyme powder formulation to manage IBS symptoms in patients who previously responded to a Mediterranean low FODMAP diet. The study aims to confirm whether this enzyme formulation can help control IBS symptoms effectively, building on prior diet-based results. Participants who responded to a Mediterranean Diet Adjusted Low FODMAP diet in an earlier trial and experienced symptom recurrence after one year are eligible. Each patient will receive a jar or sachets of digestive enzyme powder to use according to manufacturer instructions for one month. Patients will be trained on proper use through personal instruction and educational materials. Compliance will be checked by measuring the remaining powder after treatment. To reduce placebo effects, patients will be informed that half may receive a placebo, although no control group is included due to sample size constraints. During the study, participants will report the average number of daily meals on three separate days, including a weekend day. Researchers will assess changes in IBS symptoms using the IBS Severity Scoring System (IBS-SSS) from baseline to one month after treatment. The study focuses on patients with moderate to severe symptoms (IBS-SSS over 175) who previously showed improvement with the diet. Total participation duration includes baseline evaluation and one month of treatment with monitoring of symptom changes and treatment adherence.

Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD