VA Puget Sound
Seattle, Washington, 98108, United States
NCT Number: NCT01619384
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 8-week validated stress reduction program, designed to teach mindfulness.
Time frame: baseline, 8 weeks, 4-month follow-up
characterization of the intestinal microbiome is a primary endpoint
Seattle Institute for Biomedical and Clinical Research
Other
Pyrosequencing to Identify Alterations in Intestinal Microbiota Following a Stress Reduction Course
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05862467
Autism, Autism Spectrum Disorder
Laramie, Wyoming, United States
View Trial DetailsNCT06130501
Chemically-Induced Disorders, Mental Disorders
Cape Girardeau, Missouri, United States
View Trial DetailsNCT05280691
Anxiety Disorders, Behavior
Winterthur, Canton of Zurich, Switzerland
View Trial DetailsNCT07108608
Chemically-Induced Disorders, Mental Disorders
Baltimore, Maryland, United States
View Trial Details