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

June 13, 2016 updated by: NAFTALI TIMNA

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Gastroenterology institute Meir Hospital
        • Principal Investigator:
          • Timna Naftali, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: treatment with study drug
patients receiving study drug for 4 weeks. 3 capsules a day of coltect
Dietary supplement: coltect
green tea 250 mg, selenium 100 micro gram, curcumin 500 mg
Placebo Comparator: placebo
patients receiving similar capsules but no active ingredients
Dietary supplement: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of IBS symptoms and quality of life
Time Frame: 10 weeks
improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in bacterial stool flora
Time Frame: 10 weeks
stool tests to investigate change in intestinal flora during the study.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NAFTALI TIMNA

Investigators

  • Principal Investigator: Timna Naftali, MD, Meir MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bp004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe