Inuline Supplement in Patients With Irritable Bowel Syndrome

NCT03174561 | Unknown

• 1 other identifier: STCL009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Inuline, Choline and Silymarin + Diet

OTHER

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

Diet restriction

OTHER

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

Interventions

Inuline, Choline and Silymarin DIETARY_SUPPLEMENT

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.

Also known as: Stoptoxin plicuri

Inuline, Choline and Silymarin + Diet

diet restriction OTHER

diet restriction for 28 days

Diet restriction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SC Fiterman Pharma SRL: lead

Study Sites (1)

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

Iași, Romania

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Choline; Silymarin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Vasile L Drug, Lecturer

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

  PRINCIPAL INVESTIGATOR

• Ioan Chirila, Consultant

  National Institute of public Health

  STUDY CHAIR

Central Study Contacts

Vasile L Drug, Lecturer

CONTACT

+40745589065; vasidrug@email.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: May 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: April 30, 2018
• Last Updated: June 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)