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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03174561
Other study ID # STCL009
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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