A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

This study is being done to see if St. John's wort helps people with irritable bowel syndrome, otherwise known as "IBS". St. John's wort is a herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes.

Key facts

Study ID

NCT00587860

Run by

Mayo Clinic

People needed

70

Starts

2006-02-01

Expected to finish

2008-03-01

Last updated by the study team

2010-03-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established diagnosis of IBS
• Meet Rome II diagnostic criteria for IBS
• 18-70 years of age
• U.S. resident
• English-speaking (able to provide consent and complete questionnaires)
• Able to participate in all aspects of the study

You may not qualify if…

• Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, fecal incontinence, small bowel or colonic resection, pelvic floor dysfunction, paraplegia or quadriplegia)
• Current symptoms of severe depression, as measured by Center for Epidemiological Studies Depression Scale (CES-D) score
• Mental retardation or any condition requiring a legal guardian
• Current or past history of psychotic disorder (schizophrenia, bipolar disorder)
• Recent or current use (within past 30 days) of select mood or pain or symptom-altering medications:
• benzodiazepine use
• substance abuse
• narcotic use
• antihistamine use
• barbiturates
• zaleplon (Sonata)
• Recent or current use (within past 30 days) of drugs that interact with SJW:
• antidepressants or antipsychotics
• tramadol (Ultram)
• sumatriptan (Imitrex)
• digoxin (Lanoxin)
• anticonvulsants (e.g. carbamazepine or phenytoin)
• immunosuppressants: cyclosporine and tacrolimus
• HIV protease inhibitors (e.g. indinavir), non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine)
• warfarin (Coumadin)
• theophylline
• chemotherapy
• sulfa-containing drugs
• piroxicam (Feldene)
• simvastatin (Zocor)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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