Resistant Starch for Inflammatory Bowel Disease

Overseen By Ruth Singleton

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Eastern Ontario

Must be taking: Oral corticosteroids, Aminosalicylates

Must not be taking: Antibiotics

Disqualifiers: Diabetes, Drug dependence, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is 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 does require that you are already on oral corticosteroids or aminosalicylates for induction therapy. If you need antibiotics for other conditions, you may not be eligible to participate.

Is resistant starch safe for humans?

Resistant starch is generally safe for humans and has been shown to have mild laxative effects, increasing stool weight and frequency. It is digested in the large intestine and can increase the production of beneficial short-chain fatty acids, although some people may have difficulty breaking it down. ^{1 2 3 4 5}

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 colon to produce short-chain fatty acids, which can benefit gut health. This fermentation process may alter the gut microbiome and improve colonic health, offering a different approach compared to traditional treatments that often focus on reducing inflammation directly. ^{1 6 7 8 9}

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

Research suggests that resistant starch (RS) can improve colonic health by being fermented into short-chain fatty acids like butyrate, which is beneficial for the colon. Additionally, RS has been shown to have mild laxative effects and can increase stool weight, which may help manage symptoms in conditions like inflammatory bowel disease. ^{2 3 7 9 10}

Who Is on the Research Team?

Alain Stintzi, PhD

Principal Investigator

University of Ottawa

David Mack, MD, FRCPC

Principal Investigator

Children's Hospital of Eastern Ontario

Are You a Good Fit for This Trial?

This trial is for kids with new mild/moderate ulcerative colitis or moderate/severe Crohn's Disease who've started treatment with steroids or aminosalicylates. They must be responding to therapy and able to follow the study rules, like giving stool samples. Kids can't join if they're dependent on drugs/alcohol, allergic to resistant starch, taking other experimental treatments, unwilling to consent, don’t respond to starch in tests, need antibiotics for Crohn's complications or have diabetes.

Inclusion Criteria

Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study

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

I can make my own medical decisions or have someone who can.

Exclusion Criteria

Inability or unwillingness of an individual or legal guardian to give written informed consent

I need treatment beyond oral steroids or aminosalicylates.

Treatment with another investigational drug or intervention throughout the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either resistant starch or placebo daily for approximately 5 months

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Resistant Starch

Trial Overview The study is testing whether a plant-based resistant starch tailored for each child can help treat inflammatory bowel disease by improving gut health. Participants will either get this special starch or a placebo (a harmless substance that has no effect). The goal is to see if the starch makes their guts healthier.

How Is the Trial Designed?

Group I: Resistant Starch Active Control 1 Intervention

Once daily oral consumption of 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months

Group II: Placebo Placebo Group 1 Intervention

Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months

Who Is Running the Clinical Trial?

Children's Hospital of Eastern Ontario

Lead Sponsor

Trials

134

Recruited

61,000+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

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. 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]

7. 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]

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]