Inuline Supplement in Patients With Irritable Bowel Syndrome

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: diet restriction; Dietary Supplement: Inuline, Choline and Silymarin

• Registration Number: NCT03174561
• Lead Sponsor: SC Fiterman Pharma SRL

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-01
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-02
• Last Update Posted: 2017-06-02
• Primary Completion: 2018-02-28
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients aged 18-75 years, diagnosed with Irritable Bowel Syndrome using Roma IV criteria

Exclusion Criteria

• Patients with IBS with predominant diarrhea or mixt symptoms
• Patients with known hypersensitivity to any of the ingredients of the dietary supplement
• Patients who used prebiotic, probiotic or laxative products in the last 10 days
• Pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diet restriction	diet restriction	Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions for 28 days. After the first month the patients are crossed between groups.
Inuline, Choline and Silymarin + Diet	Inuline, Choline and Silymarin	Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions together with a dietary supplement. Intervention: Dietary Supplement, a combination of Inuline, Silymarin and Choline The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days

Primary Outcome Measures

Name	Time	Method
IBS symptoms severity score	the last 10 days	visual analogue scale for IBS symptoms severity will be used
number of bowel movements	the last 7 days	number of bowel movements/week

Trial Locations

Locations (1)

Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"; 🇷🇴 Iasi, Romania