Inuline Supplement in Patients With Irritable Bowel Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Inuline, Choline and Silymarin; Other: diet restriction

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vasile L Drug, Lecturer; Phone Number: +40745589065; Email: vasidrug@email.com

Study Locations

• Romania
  • Iasi, Romania
    • Recruiting
    • Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"
    • Contact: Vasile L Drug, Lecturer; Email: vasidrug@email.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inuline, Choline and Silymarin + Diet; 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	Dietary supplement: Inuline, Choline and Silymarin; Combination of one sachet: Inuline (5000 mg), Silybum marianum seed extract (50 mg), Choline (37 mg) The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days. Diet restriction is consider together with dietary supplement intake.; Other Names: Stoptoxin plicuri
Other: 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.	Other: diet restriction; diet restriction for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS symptoms severity score	visual analogue scale for IBS symptoms severity will be used	the last 10 days
number of bowel movements	number of bowel movements/week	the last 7 days

Collaborators and Investigators

• Sponsor: SC Fiterman Pharma SRL
• Investigators: Principal Investigator: Vasile L Drug, Lecturer, Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi; Study Chair: Ioan Chirila, Consultant, National Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): February 28, 2018
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Protective Agents; Hypolipidemic Agents; Lipid Regulating Agents; Antioxidants; Nootropic Agents; Lipotropic Agents; Choline; Silymarin
• Other Study ID Numbers: STCL009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No