Mindfulness-Based Stress Reduction and the Microbiome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT01619384
First received: June 11, 2012
Last updated: November 13, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


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 ] [ 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 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • posttraumatic stress disorder

Exclusion Criteria:

  • psychosis
  • suicidal ideation with intent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: November 13, 2013
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 July 31, 2014