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Mindfulness-Based Stress Reduction and the Microbiome

This study has been completed.
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 17, 2014
Last verified: November 2014

June 11, 2012
November 17, 2014
July 2010
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01619384 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Mindfulness-Based Stress Reduction and the Microbiome
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Irritable Bowel Syndrome
Behavioral: Mindfulness-Based Stress Reduction
An 8-week validated stress reduction program, designed to teach mindfulness.
  • No Intervention: Treatment as Usual
    Usual VA care
  • Experimental: MBSR
    participation in an 8-week stress reduction course (mindfulness-based stress reduction)
    Intervention: Behavioral: Mindfulness-Based Stress Reduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • posttraumatic stress disorder

Exclusion Criteria:

  • psychosis
  • suicidal ideation with intent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01619384
MIRB# 00044
No
Seattle Institute for Biomedical and Clinical Research
Seattle Institute for Biomedical and Clinical Research
American College of Gastroenterology
Principal Investigator: David Kearney, MD Seattle Institute for Biomedical and Clinical Research
Seattle Institute for Biomedical and Clinical Research
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP