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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01167673
Recruitment Status : Unknown
Verified June 2016 by NAFTALI TIMNA, Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : July 22, 2010
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: coltect Dietary Supplement: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome
Study Start Date : April 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. change in bacterial stool flora [ Time Frame: 10 weeks ]
    stool tests to investigate change in intestinal flora during the study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01167673

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Contact: AYA Oren, MD 972-9-7471017

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Gastroenterology institute Meir Hospital Recruiting
Kfar Saba, Israel
Contact: aya oren, Mrs    972-9-7471017   
Contact: Timna Naftali, MD    972-9-7472580   
Principal Investigator: Timna Naftali, MD         
Sponsors and Collaborators
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Principal Investigator: Timna Naftali, MD Meir MC
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Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center Identifier: NCT01167673    
Other Study ID Numbers: bp004
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Keywords provided by NAFTALI TIMNA, Meir Medical Center:
irritable bowel syndrome
green tea
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases