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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• sibutramine (Meridia)

• verapamil (Calan or Isoptin)

• Planned surgery (especially transplant) or anesthesia exposure during trial

• Known photosensitivity or planned photodiagnostic or phototherapy procedures

• Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, and abstinence)

• Recent or current use (within 30 days) of SJW, other herbal products for IBS, investigational drug use

• Known allergy to SJW

• Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease

• Recent history of alcohol or substance dependence use or abuse

• Another household member or relative participating in the study

• Professional drivers or operators of heavy machinery

• Major cardiovascular events in the last 6 months

• Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days)