Digestive Enzyme Formulation in Irritable Bowel Syndrome Patients Previously Responding to Mediterranean Low FODMAP Diet: Single-Arm Clinical Trial

What this Trial Is About

Irritable bowel syndrome (IBS) is a common chronic digestive disorder causing abdominal pain, bloating, gas, and changes in bowel habits without clear structural or biochemical 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 explore if this enzyme treatment can help when symptoms return after one year. Participants will receive a jar or sachets with digestive enzymes in powder form to use daily for one month, following manufacturer instructions and based on their meal intake. To reduce placebo effects, patients will be told that half may receive a placebo, though all receive the enzyme formulation. Compliance will be monitored by measuring the remaining powder. Training will be provided through personal sessions, videos, and leaflets to ensure correct usage. During the study, patients will report their symptoms through questionnaires such as the IBS Severity Scoring System (IBS-SSS), the Gastrointestinal Symptom Rating Scale for IBS, SF-12 health survey, and IBS quality of life assessments over the one-month period. Researchers will track symptom changes from the start to the end of treatment and monitor adherence by weighing returned product. The total participation time spans about one month after initial enrollment.

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