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Mindfulness-Based Stress Reduction and the Microbiome

Primary Purpose

Posttraumatic Stress Disorder, Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress, irritable bowel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • posttraumatic stress disorder

Exclusion Criteria:

  • psychosis
  • suicidal ideation with intent

Sites / Locations

  • VA Puget Sound

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual

MBSR

Arm Description

Usual VA care

participation in an 8-week stress reduction course (mindfulness-based stress reduction)

Outcomes

Primary Outcome Measures

Change in intestinal microbiome
characterization of the intestinal microbiome is a primary endpoint

Secondary Outcome Measures

Full Information

First Posted
June 11, 2012
Last Updated
November 17, 2014
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
American College of Gastroenterology
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1. Study Identification

Unique Protocol Identification Number
NCT01619384
Brief Title
Mindfulness-Based Stress Reduction and the Microbiome
Official Title
Pyrosequencing to Identify Alterations in Intestinal Microbiota Following a Stress Reduction Course
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
American College of Gastroenterology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Irritable Bowel Syndrome
Keywords
posttraumatic stress, irritable bowel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Usual VA care
Arm Title
MBSR
Arm Type
Experimental
Arm Description
participation in an 8-week stress reduction course (mindfulness-based stress reduction)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Intervention Description
An 8-week validated stress reduction program, designed to teach mindfulness.
Primary Outcome Measure Information:
Title
Change in intestinal microbiome
Description
characterization of the intestinal microbiome is a primary endpoint
Time Frame
baseline, 8 weeks, 4-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: posttraumatic stress disorder Exclusion Criteria: psychosis suicidal ideation with intent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kearney, MD
Organizational Affiliation
Seattle Institute for Biomedical and Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Mindfulness-Based Stress Reduction and the Microbiome

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