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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 14, 2016
June 1, 2016
6.7 years
July 21, 2010
June 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
change in bacterial stool flora
10 weeks
Study Arms (2)
treatment with study drug
ACTIVE COMPARATORpatients receiving study drug for 4 weeks. 3 capsules a day of coltect
placebo
PLACEBO COMPARATORpatients receiving similar capsules but no active ingredients
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NAFTALI TIMNAlead
Study Sites (1)
Gastroenterology institute Meir Hospital
Kfar Saba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timna Naftali, MD
Meir MC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 22, 2010
Study Start
April 1, 2011
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
June 14, 2016
Record last verified: 2016-06