Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464952
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Microbiome Modulation With Prebiotics in PTSD and Cirrhosis
Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Organization:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Study Overview
Official Title:
Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation RESIST-PTSD
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESIST-PTSD
Brief Summary:
Despite medical advancements PTSD remains a major issue in Veterans1 Current treatment strategies have relatively poor adherence In patients with PTSD and cirrhosis there is greater cognitive impairment as well as changes in gut microbiome structure and function23 In addition when there is concomitant cirrhosis medication-related treatment options become even narrower from a safety and tolerability perspective and cognitive issues pertaining to cirrhosis could impact participation3 Changes in gut microbiome in Veterans with cirrhosis and PTSD compared to those with cirrhosis without PTSD is characterized by a greater relative expression of pathobionts and reduction in stool microbiome diversity with reduction in bacteria that produce beneficial short chain fatty acids SCFA2 Modulation of the gut microbiome in patients with cirrhosis and PTSD may be an important therapeutic target In prior studies with cirrhosis alone microbial modulation using diet antibiotics such as rifaximin probiotics and fecal microbiota transplant have improved gut microbial diversity and clinical outcomes in some cases45 In patients with cirrhosis without PTSD and in patients with PTSD without cirrhosis there is emerging evidence regarding prebiotics and other forms of gut microbial modulation
Prebiotics are such an example6 Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota good bacteria in the gut6 Resistant starches RS are dietary fiber prebiotics found naturally in many foods including potatoes plantains and legumes67 In addition to being highly accessible RS have been shown to be well tolerated with few adverse reactions While no studies of RS exist in PTSD cirrhosis patients a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7 However there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches These starches can improve SCFA production in elderly subjects which could in turn affect the gut-brain axis favorably8
Prebiotics are such an example6 Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota good bacteria in the gut6 Resistant starches RS are dietary fiber prebiotics found naturally in many foods including potatoes plantains and legumes67 In addition to being highly accessible RS have been shown to be well tolerated with few adverse reactions While no studies of RS exist in PTSD cirrhosis patients a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7 However there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches These starches can improve SCFA production in elderly subjects which could in turn affect the gut-brain axis favorably8
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None