Irritable Bowel Syndrome Clinical Trial
Official title:
Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome
The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study.
In this study patients diagnosed using Rome IV criteria with irritable bowel syndrome with
constipation are included. The study was approved by the Ethic Committee of the University
of Medicine and Pharmacy "Gr. T Popa" Iasi to be conducted at the Institute of
Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi. The
patients are assigned after a randomized scheme to one of the groups: diet restriction
scheme or diet restriction scheme plus a product with inuline, choline and silymarin. After
28 days the patients are crossed between the groups and followed for additional 28 days diet
scheme with or without inuline, choline and silymarin supplementation. All the patients are
evaluated initially, in the day 28 and in the day 57 for the stool habits, stool
characteristics using Brystol Scale and symptoms severity (abdominal pain, frequency of
abdominal pain, bloating severity, patients satisfaction in relation with stool frequency
and the impact of IBS on daily activity) as appreciated by the patients for the last 10
days.
The acquired data will be analyzed and published.
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