Prebiotics for PTSD and Liver Cirrhosis

(RESIST-PTSD Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Must not be taking: Prebiotics, Probiotics, Antibiotics, others

Disqualifiers: Alcohol abuse, Drug use, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how prebiotics, specifically resistant potato starch, might benefit individuals with both PTSD (post-traumatic stress disorder) and liver cirrhosis. The researchers aim to determine if these natural fibers can improve gut health and potentially alleviate some symptoms of these conditions. Participants will receive either resistant potato starch or a comparator to assess differences in outcomes. This trial may suit those diagnosed with PTSD and cirrhosis who are willing to follow study procedures and provide samples. As an unphased trial, it offers a unique opportunity for participants to contribute to groundbreaking research that could lead to new insights and treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use prebiotics, probiotics, certain fiber supplements, systemic antibiotics, or anti-diarrheal agents in the 30 days before starting the trial. If you're on treatment for hepatic encephalopathy, you may also need to stop.

What prior data suggests that resistant potato starch is safe for patients with PTSD and liver cirrhosis?

A previous study found that patients who took resistant potato starch daily considered it both practical and safe. Participants continued with the treatment, indicating it was easy to manage. Another study showed that resistant starch (RS) can improve gut health by producing beneficial fatty acids essential for a healthy gut.

In individuals with liver cirrhosis, RS proved safe and led to positive changes in the gut. Although specific data for those with both PTSD and cirrhosis is lacking, RS has been studied in similar conditions. Overall, RS is known to be easy to tolerate with few side effects.

While complete information isn't available for this exact group, existing research suggests that RS is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for PTSD and liver cirrhosis, which often involve medications like antidepressants or therapies targeting liver function, resistant potato starch offers a unique approach by acting as a prebiotic. This means it feeds beneficial gut bacteria, potentially improving gut health and, in turn, influencing mental and liver health. Researchers are excited about this treatment because it targets the gut-brain-liver axis, a novel mechanism that could offer benefits beyond what current options provide. Additionally, as a natural dietary fiber, it may come with fewer side effects compared to traditional medications.

What evidence suggests that resistant potato starch might be an effective treatment for PTSD and liver cirrhosis?

This trial will compare resistant potato starch, a type of prebiotic, with cellulose. Research has shown that resistant potato starch can be beneficial for conditions like PTSD and liver cirrhosis. Studies on inflammatory bowel disease (IBD) have demonstrated that resistant starches improve gut health by supporting beneficial bacteria and reducing gut damage. This suggests potential benefits for PTSD and cirrhosis, as these conditions involve changes in gut bacteria and mental health issues. Additionally, resistant starches increase short-chain fatty acids (SCFA), which may enhance the gut-brain connection. Although specific data for PTSD and cirrhosis patients is limited, evidence from related conditions is promising. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD and liver cirrhosis, focusing on those who may have cognitive impairments and altered gut microbiomes. It's not suitable for individuals without these specific conditions or those who cannot safely consume dietary supplements.

Inclusion Criteria

I am older than 18 years.

I am willing and able to follow the study rules and attend all required visits.

Ability to provide informed written consent

Exclusion Criteria

Allergies to any of the ingredients in assigned products

Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)

Unstable psychiatric illness (psychosis)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either resistant potato starch or cellulose supplementation to modulate gut microbiome

8 weeks

Regular visits for monitoring and adherence checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistant potato starch

Trial Overview The study tests the effects of powdered cellulose and resistant potato starch as prebiotics to improve gut health in patients with both PTSD and cirrhosis. The goal is to see if these natural fibers can positively affect the gut-brain axis.

How Is the Trial Designed?

Group I: Resistant potato starch Experimental Treatment 1 Intervention

Group II: Cellulose Active Control 1 Intervention

Who Is Running the Clinical Trial?

Hunter Holmes Mcguire Veteran Affairs Medical Center

Lead Sponsor

Trials

37

Recruited

21,600+

Published Research Related to This Trial

Resistant starch (both RS2 and RS3) significantly improved the colon flora in mice by increasing beneficial bifidobacteria and decreasing harmful enterobacteria, indicating a positive effect on gut health.

The intake of RS2, particularly at higher concentrations, led to increased production of short-chain fatty acids (SCFAs) and a reduction in the pH of feces and cecum content, suggesting enhanced fermentation and overall digestive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of resistant starch on colon flora of rats]. He, M., Hong, J., Yang, YX., et al.[2005]

A randomized controlled clinical trial is being conducted to explore the benefits of resistant starch, a prebiotic, for treating metabolic dysfunction-associated steatotic liver disease, which affects nearly one-third of adults worldwide.

The study aims to uncover the underlying mechanisms by which resistant starch may improve liver health in individuals with this prevalent chronic liver condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vive la resistant starch: A potential treatment for metabolic dysfunction-associated steatohepatitis. Zhang, X., Yu, J., Wong, VW.[2023]

In a study involving 14 healthy adults, both resistant starch (RS) and wheat bran (WB) significantly increased daily faecal output compared to a low-fibre baseline, with RS increasing output to 164.2 g and WB to 194.5 g.

While both types of fibre improved faecal weight, only wheat bran significantly enhanced faecal consistency, indicating that while RS is effective for increasing output, WB may be better for improving stool quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of resistant starch on laxation in healthy adults. Maki, KC., Sanders, LM., Reeves, MS., et al.[2017]

Dietary interventions, particularly the intake of resistant starches (RSs), can help alleviate non-alcoholic fatty liver disease (NAFLD) by improving gut barrier function and reducing inflammation in the gut-liver axis, as suggested by emerging evidence.

RSs promote beneficial changes in gut microbiota and enhance the production of short-chain fatty acids (SCFAs), which support immune-metabolic balance and may serve as a promising alternative therapy for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amelioratory Effect of Resistant Starch on Non-alcoholic Fatty Liver Disease via the Gut-Liver Axis. Zhu, W., Zhou, Y., Tsao, R., et al.[2022]

In a study of 93 male veterans with cirrhosis, those with combat-related PTSD exhibited poorer cognitive performance and lower gut microbial diversity, indicating a potential link between gut health and cognitive function.

PTSD was associated with higher levels of harmful bacteria (pathobionts) like Enterococcus and Escherichia/Shigella, and lower levels of beneficial bacteria, suggesting that targeting gut microbiota may offer a new therapeutic approach for improving cognitive outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder is associated with altered gut microbiota that modulates cognitive performance in veterans with cirrhosis. Bajaj, JS., Sikaroodi, M., Fagan, A., et al.[2020]

A daily intake of 12 g of a prebiotic fiber supplement significantly increased beneficial Bifidobacterium species in the gut microbiome of 20 healthy adults on a low-fiber diet, indicating its efficacy in improving gut health.

The study also found that this prebiotic supplementation led to increased production of health-promoting metabolites, such as indolepropionate, suggesting potential benefits for overall health in individuals struggling to consume enough dietary fiber.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Omic Analyses Reveal Bifidogenic Effect and Metabolomic Shifts in Healthy Human Cohort Supplemented With a Prebiotic Dietary Fiber Blend. Kang, JW., Tang, X., Walton, CJ., et al.[2022]

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are serious liver conditions linked to metabolic syndrome, and current treatments primarily focus on lifestyle changes, which often prove ineffective.

Emerging research suggests that prebiotic fibers may offer a promising therapeutic approach for NAFLD and NASH by positively altering gut microbiota, reducing body fat, and improving glucose regulation, warranting further clinical trials in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of prebiotic fibre for treatment and management of non-alcoholic fatty liver disease and associated obesity and insulin resistance. Parnell, JA., Raman, M., Rioux, KP., et al.[2017]

A clinical trial with varying doses of a novel resistant starch blend (RSB) showed that consuming around 5 g of resistant starch daily can improve gastrointestinal symptoms over a period of 6 weeks, particularly reducing diarrhea scores.

Higher doses of the RSB blend were linked to reduced sleep disturbances and changes in gut microbiome composition, specifically increasing beneficial bacteria like Faecalibacterium and Akkermansia, which are associated with better human health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The gastrointestinal and microbiome impact of a resistant starch blend from potato, banana, and apple fibers: A randomized clinical trial using smart caps. Hanes, D., Nowinski, B., Lamb, JJ., et al.[2022]

In a study involving aged mice fed a high-fat diet, resistant starch (RS) from pulses like lentils and chickpeas significantly improved gut health by modulating the gut microbiome and reducing gut permeability, particularly enhancing tight-junction protein expression.

The supplementation of RS led to a decrease in harmful bacteria and an increase in beneficial short-chain fatty acid-producing bacteria, suggesting that dietary pulses could serve as effective prebiotics to promote gut and metabolic health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic mechanisms of resistant starches from dietary beans and pulses on gut microbiome and metabolic health in a humanized murine model of aging. Kadyan, S., Park, G., Singh, P., et al.[2023]

A feasibility study involving 10 adults showed that daily intake of resistant potato starch (RPS) from day -7 to day 100 after allogeneic hematopoietic stem cell transplantation significantly increased fecal butyrate levels, indicating a positive impact on gut health (P < 0.0001).

The study also found that RPS led to more stable plasma metabolites in participants compared to historical controls, suggesting potential benefits for metabolic health post-transplant, and a phase 2 trial is planned to further investigate its effects on graft-versus-host disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. Riwes, MM., Golob, JL., Magenau, J., et al.[2023]

Resistant starch type 2 (RS2) has been shown to positively influence metabolic health by modifying the gut microbiome, as evidenced by consistent findings across 48 studies (13 human and 35 animal) that report increased production of beneficial short-chain fatty acids and specific bacterial taxa enrichment.

Despite the overall positive effects of RS2, significant variability in gut microbiome responses was observed, influenced by factors such as study methodology, host genetics, and baseline microbial composition, highlighting the complexity of dietary interventions targeting gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conserved and variable responses of the gut microbiome to resistant starch type 2. Bendiks, ZA., Knudsen, KEB., Keenan, MJ., et al.[2021]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06464952/microbiome-modulation-with-prebiotics-in-ptsd-and-cirrhosis

Microbiome Modulation With Prebiotics in PTSD and Cirrhosis 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6879889/

Posttraumatic stress disorder is associated with altered gut ... Posttraumatic stress disorder is associated with altered gut microbiota that modulates cognitive performance in veterans with cirrhosis.

3. withpower.com withpower.com/trial/phase-2-liver-cirrhosis-5-2024-e226d

Resistant Potato Starch for Liver Cirrhosis Research suggests that dietary fiber, a component of resistant potato starch, is linked to a lower risk of liver diseases like non-alcoholic fatty liver disease ...

4. examine.com examine.com/research-feed/study/1Yevo1/?srsltid=AfmBOopCMlO-R7KdW2lb4-qlcuKc2Cdhecg3vs2904kJq27vxUPsSSNd

Can prebiotics enhance PTSD treatment outcomes? This study highlights the effectiveness of cognitive behavioral therapy for PTSD but does not provide strong evidence that prebiotic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06949631

Study on the Effects of Resistant Potato Starch on Gut ... The goal of this clinical trial is to evaluate how taking Resistant Potato Starch affects the gut microbiota compared to a placebo, in healthy adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10819196/

Resistant starch and the gut microbiome - PubMed Central - NIH Resistant starch (RS) modulates gut microbiome for health benefits. RS fermentation produces vital volatile fatty acids for gut health.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03983772

Resistant Starch Blend Gastrointestinal Impact This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase ...