Inuline Supplement in Patients With Irritable Bowel Syndrome

Fiterman Pharma

Status: Unknown

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Inuline, Choline and Silymarin; Other: diet restriction

Study type: Interventional

Funder types: Industry

Identifiers

NCT03174561

STCL009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Inuline, Choline and Silymarin + Diet

Other group

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

Treatment:

Dietary Supplement: Inuline, Choline and Silymarin

Diet restriction

Other group

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.

Treatment:

Other: diet restriction