A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- improvement of IBS symptoms and quality of life
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- 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,
Arms & Interventions
placebo
patients receiving similar capsules but no active ingredients
Intervention: Placebo (Dietary Supplement)
treatment with study drug
patients receiving study drug for 4 weeks. 3 capsules a day of coltect
Intervention: coltect (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- change in bacterial stool flora(10 weeks)
Investigators
NAFTALI TIMNA
MD
Meir Medical Center