Inuline Supplement in Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Inuline, Choline and Silymarin
* Other: diet restriction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inuline, Choline and Silymarin + Diet<br>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<br>* 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.<br>* Other names: Stoptoxin plicuri;|
| Other: Diet restriction<br>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<br>* diet restriction for 28 days<br>|

What is the study measuring?
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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 |