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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01167673

Enrollment

Registered

2010-07-22

Start date

2011-04-30

Completion date

2018-06-30

Last updated

2016-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome, selenium, curcumin, green tea

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

Interventions

DIETARY_SUPPLEMENTcoltect

green tea 250 mg, selenium 100 micro gram, curcumin 500 mg

DIETARY_SUPPLEMENTPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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,

Design outcomes

Primary

Measure	Time frame	Description
improvement of IBS symptoms and quality of life	10 weeks	improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.

Secondary

Measure	Time frame	Description
change in bacterial stool flora	10 weeks	stool tests to investigate change in intestinal flora during the study.

Countries

Israel

Contacts

Primary ContactAYA Oren, MD

aya.oren@clalit.org.il972-9-7471017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026