Clinical trial NCT00587860: A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
Official title: A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Eligibility criteria:

1. Established diagnosis of IBS
2. 18-70 years of age

4) U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6) Able to participate in all aspects of the study

You will be asked to do the following:

* Undergo a screening interview and physical examination
* Take a urine pregnancy test (if applicable)
* Take a study pill twice daily for 12 weeks(3 months)
* Complete daily symptom diaries and bi-weekly questionnaires for 12 weeks.
* Complete a questionnaire at 6 months after the active phase of the study is over.

Eligibility 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)

Primary outcomes:
measure: Overall Bowel Symptom Scores (BSS)
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Bowel Symptom Score (BSS) Amongst Subgroups
timeFrame: 12 weeks
measure: Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy
timeFrame: Last 4 weeks of therapy
measure: Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score
timeFrame: 12 weeks of treatment
measure: Center for Epidemiologic Studies Depression Scale (CES-D) Score
timeFrame: 12 weeks
measure: IBS Symptoms Moderately or a Lot Better
timeFrame: 24 weeks
measure: Center for Epidemiologic Studies Depression Scale (CES-D) Score
timeFrame: 24 weeks
measure: Bowel Symptom Score (BSS) at 24 Weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yuri A. Saito Loftus, M.D. M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: