Irritable Bowel Syndrome
Conditions
Keywords
irritable bowel syndrome, constipation, diarrhea, gas, bloating, abdominal pain, disturbance of defecation, irritable colon
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTcurcumin
curcumin 900mg twice daily by mouth
DIETARY_SUPPLEMENTplacebo
placebo capsule to simulate 900mg curcumin capsule
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed