Back to resultsThe Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
coltect
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring irritable bowel syndrome, selenium, curcumin, green tea
Eligibility 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,
Sites / Locations
- Gastroenterology institute Meir HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
treatment with study drug
placebo
Arm Description
patients receiving study drug for 4 weeks. 3 capsules a day of coltect
patients receiving similar capsules but no active ingredients
Outcomes
Primary Outcome Measures
improvement of IBS symptoms and quality of life
improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.
Secondary Outcome Measures
change in bacterial stool flora
stool tests to investigate change in intestinal flora during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01167673
Brief Title
The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
NAFTALI TIMNA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
irritable bowel syndrome, selenium, curcumin, green tea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment with study drug
Arm Type
Active Comparator
Arm Description
patients receiving study drug for 4 weeks. 3 capsules a day of coltect
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
patients receiving similar capsules but no active ingredients
Intervention Type
Dietary Supplement
Intervention Name(s)
coltect
Intervention Description
green tea 250 mg, selenium 100 micro gram, curcumin 500 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
improvement of IBS symptoms and quality of life
Description
improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
change in bacterial stool flora
Description
stool tests to investigate change in intestinal flora during the study.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AYA Oren, MD
Phone
972-9-7471017
Email
aya.oren@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timna Naftali, MD
Organizational Affiliation
Meir MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology institute Meir Hospital
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aya oren, Mrs
Phone
972-9-7471017
Email
aya.oren@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Timna Naftali, MD
Phone
972-9-7472580
Email
timna.naftali@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Timna Naftali, MD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome
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