Irritable Bowel Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTInuline, 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.
OTHERdiet restriction
diet restriction for 28 days
Sponsors
SC Fiterman Pharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS symptoms severity score | the last 10 days | visual analogue scale for IBS symptoms severity will be used |
| number of bowel movements | the last 7 days | number of bowel movements/week |
Countries
Romania
Contacts
Primary ContactVasile L Drug, Lecturer
Outcome results
None listed