Irritable Bowel SyndromePhase 2NCT01167673
The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome
A Phase 2 study testing coltect in people with Irritable Bowel Syndrome, run by NAFTALI TIMNA at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- coltect
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Gastroenterology institute Meir Hospital
Kfar Saba
aya oren, Mrs, 972-9-7471017, aya.oren@clalit.org.il
Timna Naftali, MD, 972-9-7472580, timna.naftali@clalit.org.il
About this study
Official title: A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome
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.
Read the 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
- Conditions
- Irritable Bowel Syndrome
- Being tested
- coltect, Placebo
- Keywords
- irritable bowel syndrome, selenium, curcumin, green tea
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coltectDietary supplement
green tea 250 mg, selenium 100 micro gram, curcumin 500 mg
PlaceboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| treatment with study drug | Active comparator | patients receiving study drug for 4 weeks. 3 capsules a day of coltect Receives: Dietary Supplement: coltect |
| placebo | Placebo comparator | patients receiving similar capsules but no active ingredients Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of IBS symptoms and quality of life
improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.
Measured: 10 weeks
Secondary outcomes (1)
change in bacterial stool flora
stool tests to investigate change in intestinal flora during the study.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startApr 2011
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NAFTALI TIMNA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NAFTALI TIMNA, Meir Medical Center
- Investigators
- Timna Naftali, MD, Principal investigator, Meir MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167673
- Sponsor's protocol ID
- bp004
- Status last verified
- Jun 2016
- First submitted
- 21 Jul 2010
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01167673
- Acronym / sponsor ID
- bp004
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, selenium, curcumin, green tea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NAFTALI TIMNAUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment with study drug | Active comparator | Dietary Supplement: coltectpatients receiving study drug for 4 weeks. 3 capsules a day of coltect |
| placebo | Placebo comparator | Dietary Supplement: Placebopatients receiving similar capsules but no active ingredients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coltectgreen tea 250 mg, selenium 100 micro gram, curcumin 500 mg | Dietary supplement | treatment with study drug |
| Placeboplacebo | Dietary supplement | placebo |
Primary outcome
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.
1 secondary outcome
change in bacterial stool flora
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
Related trials for Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Not yet recruiting
Effects of Epetôme on Gastrointestinal Function, Inflammation and Wellbeing in Adults With IBS-like Symptoms (EPEGUT)
IBS - Irritable Bowel Syndrome, Gastrointestinal Motility Disorder
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timna Naftali, MD principal investigator
Meir MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing coltect in people with Irritable Bowel Syndrome, run by NAFTALI TIMNA at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AYA Oren, MD (972-9-7471017, aya.oren@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of IBS symptoms and quality of life (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.