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Mindfulness-Based Stress Reduction and the Microbiome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619384
First Posted: June 14, 2012
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pyrosequencing to Identify Alterations in Intestinal Microbiota Following a Stress Reduction Course

Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Change in intestinal microbiome [ Time Frame: baseline, 8 weeks, 4-month follow-up ]
    characterization of the intestinal microbiome is a primary endpoint


Enrollment: 55
Study Start Date: July 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • posttraumatic stress disorder

Exclusion Criteria:

  • psychosis
  • suicidal ideation with intent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619384


Locations
United States, Washington
VA Puget Sound
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
American College of Gastroenterology
Investigators
Principal Investigator: David Kearney, MD Seattle Institute for Biomedical and Clinical Research
  More Information

Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT01619384     History of Changes
Other Study ID Numbers: MIRB# 00044
First Submitted: June 11, 2012
First Posted: June 14, 2012
Last Update Posted: November 19, 2014
Last Verified: November 2014

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
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders