Mindfulness-Based Stress Reduction and the Microbiome

Irritable Bowel Syndrome Clinical Trial

Official title:

Pyrosequencing to Identify Alterations in Intestinal Microbiota Following a Stress Reduction Course

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619384
• Other study ID #: MIRB# 00044
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: November 17, 2014
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• posttraumatic stress disorder

Exclusion Criteria:

• psychosis

• suicidal ideation with intent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction
An 8-week validated stress reduction program, designed to teach mindfulness.

Locations

Country	Name	City	State
United States	VA Puget Sound	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intestinal microbiome	characterization of the intestinal microbiome is a primary endpoint	baseline, 8 weeks, 4-month follow-up	No