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

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00779493
First received: October 22, 2008
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Dietary Supplement: curcumin
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Title: Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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. [ Time Frame: at 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: end of observation and the end of treatment periods ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Curcumin 900mg twice daily by mouth
Dietary Supplement: curcumin
curcumin 900mg twice daily by mouth
Other Name: Swanson vitamins-curcumin
Placebo Comparator: B
Placebo capsule to be made by Swanson Vitamins to simulate the capsule.
Dietary Supplement: placebo
placebo capsule to simulate 900mg curcumin capsule
Other Name: Swanson curcumin placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779493

Locations
United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: chris n conteas, md Kaiser Permanente
  More Information

No publications provided

Responsible Party: Chris Nicholas Conteas, MD, Kaiser Permanente-Southern California
ClinicalTrials.gov Identifier: NCT00779493     History of Changes
Other Study ID Numbers: 4893
Study First Received: October 22, 2008
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
irritable bowel syndrome
constipation
diarrhea
gas
bloating
abdominal pain
disturbance of defecation
irritable colon

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Curcumin
Vitamins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014