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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center

Tracking Information
First Submitted Date  ICMJE July 21, 2010
First Posted Date  ICMJE July 22, 2010
Last Update Posted Date June 14, 2016
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
improvement of IBS symptoms and quality of life [ Time Frame: 10 weeks ]
improvement of IBS symptoms and quality of life assesed by IBS and QOL quassionairs
Change History Complete list of historical versions of study NCT01167673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
change in bacterial stool flora [ Time Frame: 10 weeks ]
stool tests to investigate change in intestinal flora during the study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome
Official Title  ICMJE A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Dietary Supplement: coltect
    green tea 250 mg, selenium 100 micro gram, curcumin 500 mg
  • Dietary Supplement: Placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: treatment with study drug
    patients receiving study drug for 4 weeks. 3 capsules a day of coltect
    Intervention: Dietary Supplement: coltect
  • Placebo Comparator: placebo
    patients receiving similar capsules but no active ingredients
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 21, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01167673
Other Study ID Numbers  ICMJE bp004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NAFTALI TIMNA, Meir Medical Center
Study Sponsor  ICMJE NAFTALI TIMNA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timna Naftali, MD Meir MC
PRS Account Meir Medical Center
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP