Inuline Supplement in Patients With Irritable Bowel Syndrome

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03174561
• Other study ID #: STCL009
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2017
• Last updated: June 1, 2017
• Start date: May 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2017
• Source: SC Fiterman Pharma SRL
• Contact: Vasile L Drug, Lecturer
• Phone: +40745589065
• Email: vasidrug[@]email.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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:
• diet restriction
diet restriction for 28 days

Locations

Country	Name	City	State
Romania	Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
SC Fiterman Pharma SRL

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS symptoms severity score	visual analogue scale for IBS symptoms severity will be used	the last 10 days
Primary	number of bowel movements	number of bowel movements/week	the last 7 days