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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01167673
First received: July 21, 2010
Last updated: April 13, 2013
Last verified: April 2013
  Purpose

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: December 2013
Estimated Primary Completion Date: December 2013 (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
Other Name: Coltect
Placebo Comparator: placebo
patients receiving similar capsules but no active ingredients
Dietary Supplement: Placebo
placebo
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01167673

Contacts
Contact: Orly Mor, MD 972-9-7471017 orly.mor@clalit.org.il

Locations
Israel
Gastroenterology institute Meir Hospital Recruiting
Kfar Saba, Israel
Contact: Orly Mor, Mrs    972-9-7471017    orly.mor@clalit.org.il   
Contact: Timna Naftali, MD    972-9-7472580    timna.naftali@clalit.org.il   
Principal Investigator: Timna Naftali, MD         
Sponsors and Collaborators
NAFTALI TIMNA
Investigators
Principal Investigator: Timna Naftali, MD Meir MC
  More Information

No publications provided

Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01167673     History of Changes
Other Study ID Numbers: bp004
Study First Received: July 21, 2010
Last Updated: April 13, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Curcumin
Selenium
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 21, 2014