Prebiotics for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Taylor A Johnson, BS, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Bariatric surgery, Chronic gastrointestinal disease, others

Compensation: Varies

Number of Visits: 5

Duration: Approximately 30 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a special type of fiber, resistant starch, to the diet can improve gut health for people undergoing stem cell transplants for certain blood cancers like multiple myeloma. A healthier gut might aid in better recovery for patients. Participants will consume either this fiber or a placebo mixed into their food for about 10 days. Those with multiple myeloma or certain lymphomas who are scheduled for a stem cell transplant are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that resistant starch is generally safe to eat. It feeds beneficial bacteria in the gut, which can improve gut health. In individuals with early-stage type 2 diabetic kidney disease, resistant starch was used for 12 weeks without major safety concerns. Some limited research suggests it might lower cancer risk in people with Lynch syndrome, but this is still under investigation.

Overall, resistant starch is well-tolerated, with no strong evidence of harmful side effects. Participants in past studies did not report serious negative effects, indicating it is a safe option for improving gut health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for multiple myeloma, which usually involve chemotherapy, targeted therapy, and stem cell transplants, resistant starch is unique because it uses a dietary approach to potentially manage the condition. Researchers are excited about resistant starch because it acts as a prebiotic, feeding beneficial gut bacteria and possibly influencing the immune system in a positive way. This method offers a non-invasive alternative that could complement or enhance the effects of existing therapies by promoting gut health and, in turn, impacting overall immune function.

What evidence suggests that resistant starch could be an effective treatment for multiple myeloma?

Studies have shown that resistant starch, a type of prebiotic, can improve gut health by increasing beneficial bacteria like bifidobacteria and reducing harmful ones like enterobacteria. A healthy gut can significantly impact overall health, especially during treatments such as stem cell transplants. Research suggests that resistant starch may lower the risk of some cancers by up to 50%, highlighting its potential benefits. Although most studies have focused on animals or general health, the positive effects on gut bacteria suggest it could aid those undergoing treatments for conditions like multiple myeloma. In this trial, participants will receive either resistant starch or a placebo (maltodextrin) to evaluate its potential in supporting gut health during challenging medical treatments. ^{1 6 7 8 9}

Who Is on the Research Team?

Christopher R D'Angelo, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults over 19 with multiple myeloma or certain types of lymphoma who are about to have their first stem cell transplant. They must be willing to follow the study rules and provide informed consent. People can't join if they've had issues with fiber supplements, won't give stool samples, have a history of major gut surgery or chronic gut diseases, or allergies to potato starch or maltodextrin.

Inclusion Criteria

I am 19 years old or older.

I have been diagnosed with multiple myeloma, Non-Hodgkin lymphoma, or Hodgkin lymphoma.

Willing to provide informed consent

Exclusion Criteria

Not suitable for study participation due to other reasons at the discretion of the investigators

I have had weight loss surgery or suffer from a long-term gut condition.

You had a bad reaction to taking fiber supplements before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive prebiotic supplementation with resistant starch or placebo for approximately 10 days prior to stem cell infusion

10 days

1 visit (in-person) for enrollment

Treatment

Participants continue prebiotic supplementation until the first day of neutrophil engraftment

Approximately 30 days

4 visits (in-person) for fecal sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maltodextrin
• Resistant Starch

Trial Overview

The study tests whether adding resistant starch (RS) to food improves gut microbiome diversity in patients receiving stem cell transplants compared to a placebo (maltodextrin). Participants will consume RS or placebo from around 10 days before until the day their new white blood cells start growing after the transplant.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

resistant starch

Group II: Placebo Placebo Group 1 Intervention

maltodextrin

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

In a study with male Sprague-Dawley rats, a combination of resistant starch (RS) and the probiotic Bifidobacterium lactis enhanced the apoptotic response to a genotoxic carcinogen, suggesting a potential protective effect against colorectal cancer.

The moderate-RS diet not only increased beneficial bacteria and short-chain fatty acids but also elevated cell proliferation and crypt column height, indicating that RS may create a favorable environment for probiotics to exert their protective actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A synbiotic combination of resistant starch and Bifidobacterium lactis facilitates apoptotic deletion of carcinogen-damaged cells in rat colon. Le Leu, RK., Brown, IL., Hu, Y., et al.[2018]

Epidemiological studies suggest that resistant starch (RS) may provide a protective effect against colorectal cancer (CRC), with an estimated protection magnitude of 25-50%, although the measurement tools for RS consumption are not well-developed.

Human intervention studies indicate that RS consumption leads to beneficial changes in colonic biology, such as increased stool bulk and production of short-chain fatty acids, which may enhance colonic health and facilitate the removal of genetically damaged cells, potentially lowering CRC risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistant starch and colorectal neoplasia. Young, GP., Le Leu, RK.[2019]

Two novel strains of lactic acid bacteria, identified as Bifidobacterium adolescentis, were isolated from human fecal samples for their ability to utilize resistant starch (RS3), indicating their potential as probiotics.

The strain B. adolescentis JSC2 was found to be safe for human use, as it tested negative for β-glucuronidase and showed tolerance to acidic and bile-salt environments, suggesting it could be beneficial for human health and the food industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and selection of Bifidobacterium strains isolated from human feces capable of utilizing resistant starch. Kim, HJ., Shin, SI., Lee, SJ., et al.[2018]

Resistant starch (RS) is important for health because it produces butyrate in the colon, which can positively affect cell metabolism and may help inhibit the growth of colon tumors.

There is ongoing debate about how to accurately measure RS in foods, as some methods may not capture all resistant starch types, highlighting the need for better analytical techniques and clearer food labeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in dietary fibre characterisation. 2. Consumption, chemistry, physiology and measurement of resistant starch; implications for health and food labelling. Champ, M., Langkilde, AM., Brouns, F., et al.[2008]

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 diet enriched with resistant starch type 4 (RS4) significantly improved metabolic health markers in 20 individuals with metabolic syndrome, leading to lower cholesterol, fasting glucose, and body fat compared to a control group.

The RS4 diet altered gut microbiota composition, increasing beneficial bacteria and short-chain fatty acids (SCFAs) like butyrate and propionate, which are linked to improved metabolic functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of dietary resistant starch type 4 on human gut microbiota and immunometabolic functions. Upadhyaya, B., McCormack, L., Fardin-Kia, AR., et al.[2022]

Inulin, a prebiotic, was found to significantly reduce harmful coliform bacteria and increase beneficial lactobacilli in the gut of rats, suggesting it can positively alter gut microbiota during colon cancer development.

The study showed that inulin supplementation decreased markers associated with inflammation and cancer progression, such as COX-2 and NFκB, indicating its potential as a chemopreventive agent against colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes chemopreventive markers in colorectal cancer development after inulin supplementation. Hijova, E., Szabadosova, V., Strojny, L., et al.[2023]

The prebiotic xylan-stearic acid conjugate (SCXN) effectively delivers the chemotherapy drug capecitabine (Cap) in a colorectal cancer mouse model, significantly increasing the drug's concentration in tumors and enhancing its therapeutic effects.

SCXN not only improves the anti-tumor immunity and increases the tumor inhibition rate from 5.29% to 71.78%, but also extends the median survival time of CRC mice from 14 to 33.5 days, demonstrating its potential as a promising treatment strategy that combines gut microbiota modulation with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining gut microbiota modulation and chemotherapy by capecitabine-loaded prebiotic nanoparticle improves colorectal cancer therapy. Lang, T., Zhu, R., Zhu, X., et al.[2023]

A study involving healthy humans demonstrated that different types of resistant starches (RS4s) can specifically alter gut microbiome composition and metabolic activity, particularly influencing the production of beneficial short-chain fatty acids like propionate and butyrate.

The effects of these resistant starches were consistent and dose-dependent, plateauing at 35 g/day, suggesting that precise dietary fiber structures can be used to target and manipulate gut health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Microbiome Modulation with Discrete Dietary Fiber Structures Directs Short-Chain Fatty Acid Production. Deehan, EC., Yang, C., Perez-Muñoz, ME., et al.[2020]

In a study involving 24 healthy men, supplementing their diet with 32 g of resistant starch (RS) daily for 4 weeks increased stool weight and colonic fermentative activity compared to glucose, indicating some positive digestive effects.

However, the resistant starch supplements (RS2 and RS3) did not significantly alter other potential risk factors for colon cancer, such as fecal pH, short-chain fatty acid concentrations, or bile acid levels, suggesting limited impact on colon cancer risk in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited effect of consumption of uncooked (RS2) or retrograded (RS3) resistant starch on putative risk factors for colon cancer in healthy men. Heijnen, ML., van Amelsvoort, JM., Deurenberg, P., et al.[2018]

Fermentation supernatant fractions of inulin significantly increased short-chain fatty acids (SCFA) and decreased harmful bile acids, showing potential protective effects against colorectal cancer.

In human colon cell lines, particularly in early-stage cancer cells (LT97), the fermentation supernatant induced apoptosis and inhibited cell growth, suggesting that prebiotic fibers like inulin could play a role in cancer chemoprevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermentation products of inulin-type fructans reduce proliferation and induce apoptosis in human colon tumour cells of different stages of carcinogenesis. Munjal, U., Glei, M., Pool-Zobel, BL., et al.[2022]

Citations

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mdpi.com

mdpi.com/2072-6643/17/18/2973

A Systematic Review Evaluating the Impact of Fibre ...

Resistant starch (RS) is the fraction of starch that is not hydrolysed in the small intestine and fermented in the colon [51]. It has been shown to improve ...

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withpower.com

withpower.com/trial/prebiotics-for-multiple-myeloma-365db

Prebiotics for Multiple Myeloma

Resistant starch (both RS2 and RS3) significantly improved the colon flora in mice by increasing beneficial bifidobacteria and decreasing harmful enterobacteria ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3823506/

Resistant Starch: Promise for Improving Human Health - PMC

Recent and ongoing studies address the impact of digestion-resistant starches on the prevention and control of chronic human diseases.

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aacrjournals.org

aacrjournals.org/bloodcancerdiscov/article/6/5/406/764327/Food-for-Thought-Addressing-a-Research-Gap-for

Addressing a Research Gap for Dietary Trials in Hematologic ...

Changing a certain food group, such as increasing dietary fiber with resistant potato starch or inulin, can be easier for patients but may not have all the ...

5.

pharmacytimes.com

pharmacytimes.com/view/resistant-starch-in-foods-can-reduce-hereditary-cancer-by-50-

Resistant Starch in Foods Can Reduce Hereditary Cancer ...

Resistant starch, also called fermentable fiber, was found to reduce some cancers in the body by 50% in the CAPP2 trial.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10987757/

Harnessing the power of resistant starch: a narrative review ...

Resistant starch type 2 (RS2), is a native granular RS found in raw potatoes or green bananas. Its crystalline organization protects it from ...

7.

facingourrisk.org

facingourrisk.org/XRAY/resistant-starch-and-cancer-risk

Resistant starch may lower cancer risk for Lynch syndrome ...

Resistant starch was protective in patients who had multiple primary Lynch syndrome-associated cancers. ... This data is promising but limited.

8.

examine.com

examine.com/supplements/resistant-starch/?srsltid=AfmBOorFFAnPavxfWHO8-5tVnNYS1j8csWCZPhnyCIIK4TSqm__cNGik

Resistant Starch benefits, dosage, and side effects

Resistant starch acts as a food source for microbes in the gut, which can stimulate the growth of potentially beneficial bacteria and lead to the production of ...

9.

mdpi.com

mdpi.com/2304-8158/10/9/2062

Resistant Starches and Non-Communicable Disease

High–RS potato starch (with low protein) was used as a source of RS in patients with early type 2 diabetic nephropathy (DN) for 12 weeks [75]. In the study ...