Posttraumatic Stress DisorderNCT01619384
Mindfulness-Based Stress Reduction and the Microbiome
A study testing Mindfulness-Based Stress Reduction in people with Posttraumatic Stress Disorder and Irritable Bowel Syndrome, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota, assessed 8 weeks after enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Irritable Bowel Syndrome
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- posttraumatic stress disorder
Who cannot join
- psychosis
- suicidal ideation with intent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pyrosequencing to Identify Alterations in Intestinal Microbiota Following a Stress Reduction Course
This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota, assessed 8 weeks after enrollment.
Read the detailed description
The gut microbiota is known to be integral to gastrointestinal health and disease. Psychological stress has been shown to significantly alter the gastrointestinal microbiota of rats, rhesus monkeys, and humans. These studies have consistently shown decreases in lactobacilli among other changes in species that correlate with an increase in diarrheal symptoms. While it is unclear whether stress causes diarrhea leading indirectly to a disruption in the native microbiota, or whether stress leads directly to changes in the microbiota that then lead to diarrhea; there is a growing body of evidence to support the latter. Differences in microbiota have also been shown to be present in irritable bowel syndrome (IBS) and predispose or protect against other forms of diarrhea including bacterial gastroenteritis and radiation-induced diarrhea. In addition, treatment with probiotics containing lactobacillus and other species has been shown to help alleviate IBS symptoms. Stress is hypothesized to act on the microbiota via the brain-gut axis through endocrine, immunological, and/or neurological pathways. This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) \& IBS can lead to a change in the intestinal microbiota, assessed 3 weeks after enrollment. It also seeks to determine if a change in intestinal microbiota correlates with a decrease in IBS symptoms. We propose to use broad-range bacterial 16S rRNA gene PCR with 454 pyrosequencing to characterize the fecal microbiota and correlate changes in bacterial communities to IBS symptoms at baseline and after completion of an 8-week-stress reduction course in 15 patients with PTSD \& IBS and to compare these findings to 5 patients with PTSD \& IBS undergoing usual care without a stress-reduction course.
- Being tested
- Mindfulness-Based Stress Reduction
- Keywords
- posttraumatic stress, irritable bowel
- Medical subject headings
- Stress Disorders, Post-Traumatic, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
An 8-week validated stress reduction program, designed to teach mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Usual VA care |
| MBSR | Experimental | participation in an 8-week stress reduction course (mindfulness-based stress reduction) Receives: Behavioral: Mindfulness-Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal microbiome
characterization of the intestinal microbiome is a primary endpoint
Measured: baseline, 8 weeks, 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJul 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology
- Responsible party
- Sponsor
- Investigators
- David Kearney, MD, Principal investigator, Seattle Institute for Biomedical and Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619384
- Sponsor's protocol ID
- MIRB# 00044
- Status last verified
- Nov 2014
- First submitted
- 11 Jun 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrosequencing to Identify Alterations in Intestinal Microbiota Following a Stress Reduction Course
- ClinicalTrials.gov ID
- NCT01619384
- Acronym / sponsor ID
- MIRB# 00044
- Keywords
- posttraumatic stress, irritable bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- American College of Gastroenterology
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota, assessed 8 weeks after enrollment.
Detailed description
The gut microbiota is known to be integral to gastrointestinal health and disease. Psychological stress has been shown to significantly alter the gastrointestinal microbiota of rats, rhesus monkeys, and humans. These studies have consistently shown decreases in lactobacilli among other changes in species that correlate with an increase in diarrheal symptoms. While it is unclear whether stress causes diarrhea leading indirectly to a disruption in the native microbiota, or whether stress leads directly to changes in the microbiota that then lead to diarrhea; there is a growing body of evidence to support the latter. Differences in microbiota have also been shown to be present in irritable bowel syndrome (IBS) and predispose or protect against other forms of diarrhea including bacterial gastroenteritis and radiation-induced diarrhea. In addition, treatment with probiotics containing lactobacillus and other species has been shown to help alleviate IBS symptoms. Stress is hypothesized to act on the microbiota via the brain-gut axis through endocrine, immunological, and/or neurological pathways. This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) \& IBS can lead to a change in the intestinal microbiota, assessed 3 weeks after enrollment. It also seeks to determine if a change in intestinal microbiota correlates with a decrease in IBS symptoms. We propose to use broad-range bacterial 16S rRNA gene PCR with 454 pyrosequencing to characterize the fecal microbiota and correlate changes in bacterial communities to IBS symptoms at baseline and after completion of an 8-week-stress reduction course in 15 patients with PTSD \& IBS and to compare these findings to 5 patients with PTSD \& IBS undergoing usual care without a stress-reduction course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Usual VA care |
| MBSR | Experimental | Behavioral: Mindfulness-Based Stress Reductionparticipation in an 8-week stress reduction course (mindfulness-based stress reduction) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- posttraumatic stress disorder
Key exclusion criteria (2 listed)
- psychosis
- suicidal ideation with intent
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 |
|---|---|---|
| Mindfulness-Based Stress ReductionAn 8-week validated stress reduction program, designed to teach mindfulness. | Behavioural | MBSR |
Primary outcome
Change in intestinal microbiome
Time frame: baseline, 8 weeks, 4-month follow-up
characterization of the intestinal microbiome is a primary endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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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.
David Kearney, MD principal investigator
Seattle Institute for Biomedical and Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Posttraumatic Stress Disorder and Irritable Bowel Syndrome, run by Seattle Institute for Biomedical and Clinical Research 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 1 inclusion and 2 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 19 Nov 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in intestinal microbiome (time frame: baseline, 8 weeks, 4-month follow-up). 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 19 Nov 2014.