Irritable Bowel SyndromePhase 2NCT00587860
A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
A Phase 2 study testing St. John's wort in people with Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- St. John's wort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Eligibility criteria:
- Established diagnosis of IBS
- 18-70 years of age
- 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- St. John's wort, Placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. John's wortDrug
Also called Latin name: Hypericum perforatum L., Common name: St. John's Wort
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
PlaceboDrug
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| St. John's Wort | Active comparator | Not described Receives: Drug: St. John's wort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 12 weeks of treatment
Secondary outcomes (7)
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.
Measured: 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startFeb 2006
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Yuri A. Saito Loftus, M.D. M.P.H., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587860
- Sponsor's protocol ID
- 132-06
- Status last verified
- Mar 2010
- First submitted
- 27 Dec 2007
- Last updated
- 9 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00587860
- Acronym / sponsor ID
- 132-06
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Posted 1 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Established diagnosis of IBS
- 18-70 years of age
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| St. John's Wort | Active comparator | Drug: St. John's wort |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (38 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| St. John's wortAlso: Latin name: Hypericum perforatum L., Common name: St. John's WortDosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day | Drug | St. John's Wort |
| PlaceboDosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day | Drug | Placebo |
Primary outcome
Overall Bowel Symptom Scores (BSS)
Time frame: After 12 weeks of treatment
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.
7 secondary outcomes
Bowel Symptom Score (BSS) Amongst Subgroups
Time frame: 12 weeks
Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy
Time frame: Last 4 weeks of therapy
Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score
Time frame: 12 weeks of treatment
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Time frame: 12 weeks
IBS Symptoms Moderately or a Lot Better
Time frame: 24 weeks
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Time frame: 24 weeks
Bowel Symptom Score (BSS) at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
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Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuri A. Saito Loftus, M.D. M.P.H. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing St. John's wort in people with Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Bowel Symptom Scores (BSS) (time frame: After 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2010.