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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.
Eligibility criteria:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| St. John's Wort | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| St. John's wort | Drug | Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Bowel Symptom Scores (BSS) | The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain. | After 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Symptom Score (BSS) Amongst Subgroups | Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain. | 12 weeks |
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Inclusion Criteria:
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:
Recent or current use (within past 30 days) of drugs that interact with SJW:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Yuri A. Saito Loftus, M.D. M.P.H. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
For this study, there was a 2-week screening and enrollment phase. During this period, participants were screened, a symptom questionnaire was completed, and there was a physician exam. After the in-person screening visit, a phone call was made prior to mailing the study materials to ensure the participant was still willing to participate.
Participants were identified through community, institutional advertisement, clinicaltrials.gov, through the IFFGD webpage as well as through the outpatient clinics beginning in February 2006. Participants who participated in previous IBS studies were also mailed a recruitment letter to ask if they would be interested in participating.
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| ID | Title | Description |
|---|---|---|
| FG000 | St. John's Wort | St. John's Wort, 450 mg twice a day |
| FG001 | Placebo | Placebo, twice a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | St. John's Wort | St. John's Wort, 450 mg twice a day |
| BG001 | Placebo | Placebo, twice a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Bowel Symptom Scores (BSS) | The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain. | Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values. | Posted | Median | Full Range | Scores on a scale | After 12 weeks of treatment |
|
Study duration
Patients will be evaluated on a bi-weekly basis by phone interview and paper questionnaire. During these queries, subjects will be asked to report study medication compliance and side effects or adverse events (AE). Adverse events will be categorized into Serious Adverse Events (SAE) and Non-serious Adverse Events (NAE).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | St. John's Wort | St. John's Wort, 450 mg twice a day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuri A. Saito Loftus, M.D., M.P.H. | Mayo Clinic | 507-284-5010 | saito.yuri@mayo.edu |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C422326 | Hypericum extract LI 160 |
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| Placebo | Drug | Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day |
|
| Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy | Participants who reported "yes" or "no" to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy. | Last 4 weeks of therapy |
| Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score | The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. | 12 weeks of treatment |
| Center for Epidemiologic Studies Depression Scale (CES-D) Score | We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | 12 weeks |
| IBS Symptoms Moderately or a Lot Better | Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks. | 24 weeks |
| Center for Epidemiologic Studies Depression Scale (CES-D) Score | We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | 24 weeks |
| Bowel Symptom Score (BSS) at 24 Weeks | The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis. | 24 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Bowel Symptom Score (BSS) | The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis. | Median | Full Range | Units on a scale |
|
| Center for Epidemiologic Studies Depression Scale (CES-D) score | We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | Median | Full Range | Units on a scale |
|
| Irritable Bowel Syndrome - Quality of Life (IBS-QoL) | The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. | Median | Full Range | Units on a scale |
|
St. John's Wort, 450 mg twice a day
| OG001 | Placebo | Placebo, twice a day |
|
|
| Secondary | Bowel Symptom Score (BSS) Amongst Subgroups | Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain. | Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values. | Posted | Median | Full Range | Scores on a scale | 12 weeks |
|
|
|
| Secondary | Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy | Participants who reported "yes" or "no" to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy. | Posted | Number | Percentage of Participants | Last 4 weeks of therapy |
|
|
|
| Secondary | Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score | The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. | Posted | Median | Full Range | Units on a scale | 12 weeks of treatment |
|
|
|
| Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) Score | We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | Posted | Median | Full Range | Units on a scale | 12 weeks |
|
|
|
| Secondary | IBS Symptoms Moderately or a Lot Better | Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks. | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) Score | We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | Posted | Median | Full Range | Units on a scale | 24 weeks |
|
|
|
| Secondary | Bowel Symptom Score (BSS) at 24 Weeks | The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis. | Posted | Median | Full Range | Units on a scale | 24 weeks |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo | Placebo, twice a day | 0 | 35 | 0 | 35 |
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| D004066 | Digestive System Diseases |
| BSS for pain subgroup |
|
| BSS for bloating subgroup |
|
| Missing |
|
| Missing |
|