The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome

Phase 2

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: coltect

• Registration Number: NCT01167673
• Lead Sponsor: NAFTALI TIMNA

Brief Summary

Irritable bowel syndrome (IBS) causes many symptoms, including abdominal pain, irregular bowel movements and bloating. It may be caused by loe degree inflammation of the intestine. The ingredients of coltect which contains green tea, selenium, and curcumin have been proven very safe and have anti inflammatory and anti oxidant activity. The aim of the study is to see whether the use of Coltect can improve symptoms in IBS patients.

Detailed Description

The etiology of Irritable bowel syndrome is unknown but some evidence suggests it may be caused by a certain degree of inflammation, another theory is that intestinal flora has an influence on IBS. Coltect combines 3 ingredients: green tea, selenium and curcumin, all of which have been shown to have anti inflammatory and anti oxidant activity. the aim of the study is to investigate if use of coltect can improve symptoms in IBS patients

Study Timeline

• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Study Start: 2011-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-14
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• IBS as defined by the Rome III criteria
• for those above age 40 a colonoscopy within the last 5 years
• no new treatment in the last 2 weeks
• not receiving any antibiotics in the last 2 weeks

Exclusion Criteria

• any large abdominal operation (such as colectomy) in the past
• a known disease of the gastrointestinal tract
• any significant debilitating disease such as sever heart failure, un controlled diabetes,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	patients receiving similar capsules but no active ingredients
treatment with study drug	coltect	patients receiving study drug for 4 weeks. 3 capsules a day of coltect

Primary Outcome Measures

Name	Time	Method
improvement of IBS symptoms and quality of life	10 weeks	improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.

Secondary Outcome Measures

Name	Time	Method
change in bacterial stool flora	10 weeks	stool tests to investigate change in intestinal flora during the study.

Trial Locations

Locations (1)

Gastroenterology institute Meir Hospital; 🇮🇱 Kfar Saba, Israel