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

Irritable Bowel Syndrome Clinical Trial

Official title:

A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01167673
• Other study ID #: bp004
• Status: Recruiting
• Phase: Phase 2
• First received: July 21, 2010
• Last updated: June 13, 2016
• Start date: April 2011
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Meir Medical Center
• Contact: AYA Oren, MD
• Phone: 972-9-7471017
• Email: aya.oren[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• coltect
green tea 250 mg, selenium 100 micro gram, curcumin 500 mg
• Placebo
placebo

Locations

Country	Name	City	State
Israel	Gastroenterology institute Meir Hospital	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
NAFTALI TIMNA

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of IBS symptoms and quality of life	improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.	10 weeks	No
Secondary	change in bacterial stool flora	stool tests to investigate change in intestinal flora during the study.	10 weeks	No