Resistant Starch for Inflammatory Bowel Disease

Overseen By David Mack, MD, FRCPC

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Eastern Ontario

Must not be taking: Antibiotics

Disqualifiers: Diabetes, Drug dependence, Chronic disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires no changes in your standard treatment for a month before and after joining. If you have a chronic disease needing medication, you may not be eligible.

What data supports the effectiveness of the treatment Resistant Starch for Inflammatory Bowel Disease?

Resistant starch (RS) is known to be fermented in the large intestine into short-chain fatty acids, including butyrate, which is beneficial for colon health. Studies have shown that RS can increase stool weight and improve bowel movement regularity, which may help manage symptoms of inflammatory bowel disease. ^{1 2 3 4 5}

Is resistant starch safe for humans?

Resistant starch is generally safe for humans and may have mild laxative effects, increasing stool weight and frequency. It has been studied in healthy adults and patients with specific conditions, showing no major safety concerns. ^{3 5 6 7 8}

How does the treatment Resistant Starch differ from other treatments for Inflammatory Bowel Disease?

Resistant Starch is unique because it is not digested in the small intestine and is fermented in the large intestine to produce short-chain fatty acids, like butyrate, which can benefit colonic health. This fermentation process can alter the gut microbiome and potentially improve gut health, making it different from other treatments that may not target the microbiome or produce these specific metabolites. ^{2 4 7 9 10}

Research Team

Alain Stintzi, PhD

Principal Investigator

University of Ottawa

David Mack, MD, FRCPC

Principal Investigator

Children's Hospital of Eastern Ontario

Eligibility Criteria

This trial is for pediatric patients with mild or in-remission Inflammatory Bowel Disease (IBD), including Crohn's and Ulcerative Colitis, who've had stable treatment for a month. Participants must be able to follow the study procedures like stool collections and not have diabetes, drug/alcohol dependence, recent antibiotics (>2 weeks), or other chronic diseases needing medication.

Inclusion Criteria

Willing to provide consent/assent for the collection of stool samples.

I have been diagnosed with Crohn's disease or ulcerative colitis.

My Crohn's disease or ulcerative colitis is in remission or mild, with stable treatment for the last month.

Exclusion Criteria

Participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the RapidAIM evaluation following the initial stool sample collection.

Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

You are allergic to resistant starch or other substances used in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch or placebo for approximately 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Placebo
• Resistant Starch

Trial Overview The MEND Trial is testing whether a plant-based resistant starch tailored to individuals can improve gut health in kids with IBD by targeting the disease cause and altering their gut microbiome. It involves comparing this optimized starch against a placebo.

Participant Groups

Group I: Resistant Starch Active Control 1 Intervention

Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months

Group II: Placebo Placebo Group 1 Intervention

Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months

Who Is Running the Clinical Trial?

Children's Hospital of Eastern Ontario

Lead Sponsor

Trials

134

Recruited

61,000+

Findings from Research

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]

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]

In a study involving 32 Wistar rats, the addition of resistant starch RS4 to high-fat diets significantly reduced total cholesterol levels by about 25% and triglycerides by approximately 47% in those fed with soybean oil, indicating its beneficial effects on lipid metabolism.

Rats consuming diets with RS4 also showed lower liver damage, as indicated by hepatic enzyme activity, and higher levels of HDL-cholesterol compared to control groups, suggesting improved overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. Bronkowska, M., Orzeł, D., Łoźna, K., et al.[2013]

Mice fed a diet high in resistant potato starch (RPS) showed increased susceptibility to bacterial-induced colitis, with higher levels of infection and colonization by the pathogen Citrobacter rodentium compared to those not fed RPS.

The study revealed that high RPS consumption altered the microbiome composition and gene expression in the colon, potentially leading to immunosuppressive effects that could increase vulnerability to gastrointestinal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Raw potato starch alters the microbiome, colon and cecal gene expression, and resistance to Citrobacter rodentium infection in mice fed a Western diet. Smith, AD., Chen, C., Cheung, L., et al.[2023]

Long-term intake of raw potato starch (RPS) in pigs led to significant changes in gut microbial composition, decreasing harmful bacteria like Clostridium and increasing beneficial bacteria such as Ruminococcus, which may contribute to improved intestinal health.

The RPS diet also altered gene expression in the colon, increasing pro-inflammatory cytokine IL-1β while suppressing lysosomal genes, indicating that while RPS may have benefits, it could also have negative effects on gut health through immune response modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses in colonic microbial community and gene expression of pigs to a long-term high resistant starch diet. Sun, Y., Zhou, L., Fang, L., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Digestibility of resistant starch containing preparations using two in vitro models. [2018]

2. Japan pubmed.ncbi.nlm.nih.gov

Slower Fermentation Rate of Potato Starch Relative to High-amylose Cornstarch Contributes to the Higher Proportion of Cecal Butyrate in Rats. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Beneficial effects of resistant starch on laxation in healthy adults. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Physiological aspects of resistant starch and in vivo measurements. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Digestion and physiological properties of resistant starch in the human large bowel. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. [2023]

7. Poland pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Wheat bran suppresses potato starch--potentiated colorectal tumorigenesis at the aberrant crypt stage in a rat model. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Raw potato starch alters the microbiome, colon and cecal gene expression, and resistance to Citrobacter rodentium infection in mice fed a Western diet. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Responses in colonic microbial community and gene expression of pigs to a long-term high resistant starch diet. [2020]