Mindfulness-Based Stress Reduction and the Microbiome
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Posttraumatic Stress Disorder Irritable Bowel Syndrome |
Behavioral: Mindfulness-Based Stress Reduction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pyrosequencing to Identify Alterations in Intestinal Microbiota Following a Stress Reduction Course |
- Change in intestinal microbiome [ Time Frame: baseline, 8 weeks, 4-month follow-up ] [ Designated as safety issue: No ]characterization of the intestinal microbiome is a primary endpoint
| Estimated Enrollment: | 55 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Treatment as Usual
Usual VA care
|
|
|
Experimental: MBSR
participation in an 8-week stress reduction course (mindfulness-based stress reduction)
|
Behavioral: Mindfulness-Based Stress Reduction
An 8-week validated stress reduction program, designed to teach mindfulness.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- posttraumatic stress disorder
Exclusion Criteria:
- psychosis
- suicidal ideation with intent
Contacts and Locations| Contact: Michelle Martinez, BA | 206-277-1721 | michelle.martinez4@va.gov |
| United States, Washington | |
| VA Puget Sound | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: David Kearney, MD david.kearney@va.gov | |
| Principal Investigator: David Kearnaey, MD | |
| Principal Investigator: | David Kearney, MD | Seattle Institute for Biomedical and Clinical Research |
More Information
No publications provided
| Responsible Party: | Seattle Institute for Biomedical and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT01619384 History of Changes |
| Other Study ID Numbers: | MIRB# 00044 |
| Study First Received: | June 11, 2012 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
|
posttraumatic stress irritable bowel |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013