Inulin for Traumatic Brain Injury

Overseen By Christopher Danesi, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Heart, liver, kidney, blood, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a dietary fiber called Inulin can improve fatigue and thinking skills in individuals recovering from a traumatic brain injury (TBI). Researchers aim to determine if Inulin can alter the gut microbiome, potentially affecting recovery. The trial includes three groups: brain injury patients with Inulin treatment, those without, and a control group from the community. Individuals who have experienced a TBI in the last six months and are receiving care at Moody Neurorehabilitation Institute may be eligible. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on TBI recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that inulin is safe for use in this trial?

Research has shown that inulin, a type of fiber that supports beneficial gut bacteria, is generally safe. Studies have found it can aid digestion and improve gut health without major side effects, even in individuals with brain injuries. This indicates that inulin is well-tolerated and safe to use based on current findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for traumatic brain injury, which typically focus on managing symptoms through medications and rehabilitation, inulin offers a unique approach by potentially enhancing gut health and reducing inflammation. Inulin is a type of dietary fiber that acts as a prebiotic, promoting the growth of beneficial gut bacteria, which may play a role in brain health. Researchers are excited about inulin because it could offer a novel, non-invasive way to support recovery by targeting the gut-brain axis, potentially leading to improved outcomes for patients.

What evidence suggests that inulin might be an effective treatment for traumatic brain injury?

Research has shown that inulin, a type of dietary fiber, might aid people with traumatic brain injury (TBI). In studies with mice, inulin improved brain blood flow and helped repair brain structure after injury. Some evidence suggests that inulin could speed up recovery from TBI by addressing gut imbalances and brain issues. By altering the gut microbiome (the community of tiny organisms in the intestines), inulin might reduce fatigue and enhance cognitive skills in those with brain injuries. In this trial, some brain injury patients will receive inulin supplementation alongside standard care, while others will receive standard care alone. These early findings offer hope that inulin could complement current treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Ana Durand, MD

Principal Investigator

Moody Neurorehabilitation Institute

Randall Urban, MD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for individuals in post-acute residential neurorehabilitation after a traumatic brain injury. It's designed to see if their gut bacteria (microbiome) can be altered by a dietary fiber called Inulin, which might help with fatigue and thinking problems.

Inclusion Criteria

Willing and able to provide consent (with LAR if needed)

Have a family member who is admitted to Moody Neurorehabilitation Institute for care OR is working at Moody Neurorehabilitation Institute

My injury occurred less than 6 months ago.

Exclusion Criteria

I have active diverticular disease.

I have not had a stroke in the last 6 months.

Pregnancy or becoming pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral inulin supplementation (4g 2x daily) during inpatient post-acute neurorehabilitation

6 weeks

Regular visits during inpatient stay

Follow-up

Participants are monitored for changes in gut microbiome and neurologic symptoms after discontinuation of inulin

6 months

Periodic assessments at 3 and 6 months

Long-term Follow-up

Participants' fatigue and cognition are assessed using the Fatigue and Altered Cognition Scale

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Inulin

Trial Overview

The study tests whether taking Inulin, a type of dietary fiber, changes the gut microbiome and improves neurological symptoms like fatigue and cognition in people recovering from traumatic brain injuries.

How Is the Trial Designed?

Group I: Community Controls Active Control 1 Intervention

Community Control subjects will not receive intervention.

Group II: Brain Injury Patients - no intervention Active Control 1 Intervention

Brain injury patients receiving residential standard of care post-acute neurorehabilitation.

Group III: Brain Injury Patients - inulin intervention Active Control 1 Intervention

Brain injury patients receiving residential standard of care post-acute neurorehabilitation plus 42 days of daily oral inulin supplementation (4g 2x daily).

Inulin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Inulin for:

• Dietary supplement
• Prebiotic

Approved in United States as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Canada as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Japan as Inulin for:

• Dietary supplement
• Prebiotic

Approved in China as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Switzerland as Inulin for:

• Dietary supplement
• Prebiotic

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

The Moody Foundation

Collaborator

Trials

5

Recruited

210+

Moody Neurorehabilitation Institute

Collaborator

Published Research Related to This Trial

In a study of 46 neurocritical care patients, the enteric formula with prebiotic content (EFPC) led to significantly higher total energy, carbohydrate, protein, lipid, and fluid intake compared to the standard enteral formula (SEF), suggesting better nutritional support during critical care.

Patients receiving EFPC showed a non-significant trend towards achieving target nutritional doses more frequently and earlier, along with a significantly lower rate and faster improvement of diarrhea compared to those on SEF, highlighting potential benefits of prebiotics in enteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of standard enteral formula versus enteric formula with prebiotic content in nutrition therapy: A randomized controlled study among neuro-critical care patients. Tuncay, P., Arpaci, F., Doganay, M., et al.[2019]

Inulin, particularly long-chain inulin, has been shown to reduce inflammation and endotoxemia in mice fed a high-fat diet by promoting beneficial gut bacteria like Bifidobacterium and Lactobacillus.

The study suggests that dietary inulin can be an effective prebiotic strategy to combat the negative health effects of high-fat diets by enhancing the production of short-chain fatty acids and improving gut microbiota balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin with different degrees of polymerization protects against diet-induced endotoxemia and inflammation in association with gut microbiota regulation in mice. Li, LL., Wang, YT., Zhu, LM., et al.[2021]

In a 3-month randomized, placebo-controlled trial involving 24 obese patients, the intake of inulin-type fructans (ITF) significantly increased levels of beneficial gut bacteria, specifically Bifidobacterium, and reduced fecal calprotectin, a marker of gut inflammation.

The study suggests that ITF may help improve gut health in obese individuals by decreasing inflammation and potentially influencing gut microbiota-derived metabolites, although it did not significantly change short-chain fatty acid levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial. Neyrinck, AM., Rodriguez, J., Zhang, Z., et al.[2022]

Fructans, such as fructo-oligosaccharides and inulin, were found to directly influence inflammatory responses in endotoxemic mice, promoting the production of beneficial short-chain fatty acids like acetate and propionate, challenging previous beliefs about their microbiota-independent effects.

Long-term intake of prebiotic fibers reduced bacterial load in the spleen and lymph nodes but did not improve short-chain fatty acid synthesis or epithelial barrier function impaired by LPS, indicating that while these fibers have anti-inflammatory properties, their effects on gut health may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbiota-related effects of prebiotic fibres in lipopolysaccharide-induced endotoxemic mice: short chain fatty acid production and gut commensal translocation. [2021]

Chicory-derived inulin-type fructans, consumed at doses of 3-20 g/day, significantly increase the abundance of beneficial gut bacteria, specifically Bifidobacterium, in a diverse population of 2525 participants across 50 studies.

These fructans not only promote gut health by enhancing Bifidobacterium levels but also improve bowel function in healthy individuals, although their effects were less pronounced in those with gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of chicory-derived inulin-type fructans on abundance of Bifidobacterium and on bowel function: a systematic review with meta-analyses. Nagy, DU., Sándor-Bajusz, KA., Bódy, B., et al.[2022]

Combining native chicory inulin with 2'-fucosyllactose (2'-FL) enhances the fermentation process in infant gut microbiota, leading to increased production of beneficial compounds like acetate and lactate.

The fermentation products from these non-digestible carbohydrates (NDCs) have varying immune-modulatory effects, suggesting that tailored formulations could be beneficial for infants with different immune system conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chicory inulin enhances fermentation of 2'-fucosyllactose by infant fecal microbiota and differentially influences immature dendritic cell and T-cell cytokine responses under normal and Th2-polarizing conditions. Akkerman, R., Logtenberg, MJ., Beukema, M., et al.[2023]

In a review of 19 randomized controlled trials involving 777 participants, inulin-type fructan (ITF) supplementation showed limited effects on appetite and energy intake, with most studies indicating no significant changes.

However, there is some evidence suggesting that long-term ITF supplementation may help reduce body weight, particularly in nonobese adolescents and some adults, indicating potential benefits for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inulin-type fructans on appetite, energy intake, and body weight in children and adults: systematic review of randomized controlled trials. Liber, A., Szajewska, H.[2018]

Feeding prebiotic inulin to young mice before a closed head injury significantly reduced harmful bacteria and increased beneficial short-chain fatty acid-producing bacteria, which helped maintain gut health after the injury.

Inulin treatment improved recovery outcomes by protecting cerebral blood flow and white matter integrity, suggesting it could be a promising intervention for individuals at risk of mild traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin supplementation prior to mild traumatic brain injury mitigates gut dysbiosis, and brain vascular and white matter deficits in mice. Yanckello, LM., Chang, YH., Sun, M., et al.[2023]

Mild traumatic brain injury (mTBI) causes significant changes in the gut microbiome, leading to dysbiosis that can worsen brain health, with these changes peaking at 1.5 months post-injury in a study involving male mice over a 3-month recovery period.

Feeding prebiotic inulin after the injury improved gut microbiome composition by increasing beneficial bacteria and restoring cerebral blood flow, suggesting that dietary interventions could enhance recovery from mTBI and may lead to new treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin Supplementation Mitigates Gut Dysbiosis and Brain Impairment Induced by Mild Traumatic Brain Injury during Chronic Phase. Yanckello, LM., Fanelli, B., McCulloch, S., et al.[2023]

Inulin-type fructans (ITF) have been shown to positively influence the intestinal microbiota by increasing beneficial bacteria such as Bifidobacterium and Lactobacillus, which can lead to improved gut health and function.

ITF intake is associated with several health benefits, including better intestinal barrier function, improved insulin sensitivity, lower triglycerides, enhanced mineral absorption, and increased feelings of fullness, although more research is needed to understand how chain length affects these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prebiotic Potential of Inulin-Type Fructans: A Systematic Review. Hughes, RL., Alvarado, DA., Swanson, KS., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

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Inulin Supplementation Mitigates Gut Dysbiosis and Brain ...

Inulin supplementation mitigates gut dysbiosis and brain impairment induced by mild traumatic brain injury during chronic phase.

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frontiersin.org

frontiersin.org/journals/microbiomes/articles/10.3389/frmbi.2022.986951/full

Inulin supplementation prior to mild traumatic brain injury ...

These findings indicate that pretreatment with prebiotic fiber could be effective to accelerate recovery from a mild or moderate TBI. Our findings may also ...

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withpower.com

withpower.com/trial/phase-brain-injuries-9-2024-6074a

Inulin for Traumatic Brain Injury

In studies with mice, inulin was found to restore blood flow in the brain and improve brain structure after injury.

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scholars.uky.edu/es/publications/inulin-supplementation-prior-to-mild-traumatic-brain-injury-mitig/

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Inulin supplementation prior to mild traumatic brain injury mitigates gut dysbiosis, and brain vascular and white matter deficits in mice · Neuroscience ...

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mdpi.com

mdpi.com/2077-0383/13/15/4546

Probiotics in Traumatic Brain Injury: New Insights into ...

This review summarizes the current evidence regarding the beneficial effects of probiotic administration in patients suffering from TBI-related complications.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9903356/

Inulin supplementation prior to mild traumatic brain injury ...

These findings indicate that pretreatment with prebiotic fiber could be effective to accelerate recovery from a mild or moderate TBI. Our findings may also ...