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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Meir Medical Center
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center Identifier:
First received: July 21, 2010
Last updated: March 5, 2015
Last verified: March 2015
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 Intervention Phase
Irritable Bowel Syndrome
Dietary Supplement: coltect
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • improvement of IBS symptoms and quality of life [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    improvement of IBS symptoms and quality of life (QOL) assesed by IBS and QOL quassionairs

Secondary Outcome Measures:
  • change in bacterial stool flora [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    stool tests to investigate change in intestinal flora during the study.

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment with study drug
patients receiving study drug for 4 weeks
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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,
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01167673

Contact: AYA Oren, MD 972-9-7471017

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
Principal Investigator: Timna Naftali, MD Meir MC
  More Information

Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center Identifier: NCT01167673     History of Changes
Other Study ID Numbers: bp004 
Study First Received: July 21, 2010
Last Updated: March 5, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
irritable bowel syndrome
green tea

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Enzyme Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Trace Elements processed this record on May 26, 2016