Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial

Study Overview
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Brief Summary
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Evidence exists to support low-grade inflammation as the inciting factor leading to visceral hypersensitivity and alteration in motility in irritable bowel syndrome.In the medical literature,there is ample in vitro and in vivo evidence supporting turmeric and its derivative curcumin as an antitumor, anti-inflammatory and antioxidant agent. We propose a randomized, placebo-controlled, double blinded, parallel treatment study evaluating the effects of turmeric on the symptoms of irritable bowel syndrome.

Official Title
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Study Title: Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: curcumin
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from the hospitals and clinics of the Southern California Permanente Medical Group who conform to the Rome III criteria and Age 18 years and above, Male or female, Able to give consent and follow the treatment plan and be able to answer surveys. Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study. Exclusion Criteria: Any of the following: diabetes, HIV disease, use of anticoagulants or antiplatelet medication, abnormal coagulation or thrombocytopenia, biliary obstruction, inflammatory bowel, symptomatic gallstones, celiac disease, ongoing use of medications known to cause or exacerbate symptoms of IBS and chronic, daily users of IBS medications. Use of scheduled IBS medications for 4 weeks prior to and during the treatment period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Curcumin 900mg twice daily by mouth | Dietary Supplement: curcumin<br>* curcumin 900mg twice daily by mouth<br>* Other names: Swanson vitamins-curcumin;|
| Placebo Comparator: B<br>Placebo capsule to be made by Swanson Vitamins to simulate the capsule. | Dietary Supplement: placebo<br>* placebo capsule to simulate 900mg curcumin capsule<br>* Other names: Swanson curcumin placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease severity will be assessed using the irritable bowel severity score (IBSS) which utilizes a visual analog scale (VAS) (28). The primary outcome will be defined as at least 50% reduction in IBSS. |  | at 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bowel movement frequency, consistency, frequency of as-needed medication use and bloating as measured by the VAS, and improvement SF-36 Quality of Life survey. |  | end of observation and the end of treatment periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irritable bowel syndrome, constipation, diarrhea, gas, bloating, abdominal pain, disturbance of defecation, irritable colon