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Inuline Supplement in Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Inuline, Choline and Silymarin
diet restriction
Sponsored by
SC Fiterman Pharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Inuline, Choline and Silymarin + Diet

Diet restriction

Arm Description

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

Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions for 28 days. After the first month the patients are crossed between groups.

Outcomes

Primary Outcome Measures

IBS symptoms severity score
visual analogue scale for IBS symptoms severity will be used
number of bowel movements
number of bowel movements/week

Secondary Outcome Measures

Full Information

First Posted
May 31, 2017
Last Updated
June 1, 2017
Sponsor
SC Fiterman Pharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03174561
Brief Title
Inuline Supplement in Patients With Irritable Bowel Syndrome
Official Title
Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SC Fiterman Pharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inuline, Choline and Silymarin + Diet
Arm Type
Other
Arm Description
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
Arm Title
Diet restriction
Arm Type
Other
Arm Description
Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions for 28 days. After the first month the patients are crossed between groups.
Intervention Type
Dietary Supplement
Intervention Name(s)
Inuline, Choline and Silymarin
Other Intervention Name(s)
Stoptoxin plicuri
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
diet restriction
Intervention Description
diet restriction for 28 days
Primary Outcome Measure Information:
Title
IBS symptoms severity score
Description
visual analogue scale for IBS symptoms severity will be used
Time Frame
the last 10 days
Title
number of bowel movements
Description
number of bowel movements/week
Time Frame
the last 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vasile L Drug, Lecturer
Phone
+40745589065
Email
vasidrug@email.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasile L Drug, Lecturer
Organizational Affiliation
Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ioan Chirila, Consultant
Organizational Affiliation
National Institute of public Health
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"
City
Iasi
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasile L Drug, Lecturer
Email
vasidrug@email.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inuline Supplement in Patients With Irritable Bowel Syndrome

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