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

NAFTALI TIMNA

Status and phase: Unknown; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: coltect

Study type: Interventional

Funder types: Other

Identifiers

NCT01167673

bp004

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

treatment with study drug

Active Comparator group

Description:

patients receiving study drug for 4 weeks. 3 capsules a day of coltect

Treatment:

Dietary Supplement: coltect

placebo

Placebo Comparator group

Description:

patients receiving similar capsules but no active ingredients

Treatment:

Dietary Supplement: Placebo