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Mindfulness-Based Stress Reduction and the Microbiome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01619384
Enrollment
55
Registered
2012-06-14
Start date
2010-07-31
Completion date
2013-12-31
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome, Posttraumatic Stress Disorder

Keywords

posttraumatic stress, irritable bowel

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.

Interventions

BEHAVIORALMindfulness-Based Stress Reduction

An 8-week validated stress reduction program, designed to teach mindfulness.

Sponsors

American College of Gastroenterology
CollaboratorOTHER
Seattle Institute for Biomedical and Clinical Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* posttraumatic stress disorder

Exclusion criteria

* psychosis * suicidal ideation with intent

Design outcomes

Primary

MeasureTime frameDescription
Change in intestinal microbiomebaseline, 8 weeks, 4-month follow-upcharacterization of the intestinal microbiome is a primary endpoint

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026