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

Study Overview
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Brief Summary
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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
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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

Official Title
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A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: coltect
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment with study drug<br>patients receiving study drug for 4 weeks. 3 capsules a day of coltect | Dietary Supplement: coltect<br>* green tea 250 mg, selenium 100 micro gram, curcumin 500 mg<br>|
| Placebo Comparator: placebo<br>patients receiving similar capsules but no active ingredients | Dietary Supplement: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of IBS symptoms and quality of life | improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in bacterial stool flora | stool tests to investigate change in intestinal flora during the study. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irritable bowel syndrome, selenium, curcumin, green tea