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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a plant-based resistant starch to determine if it can improve gut health in children with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. The goal is to assess whether this starch can balance gut bacteria and address the root cause of IBD. Participants will take either a daily dose of this special starch or a placebo (a dummy treatment) for about six months. Children with a current diagnosis of Crohn's or ulcerative colitis, who do not expect changes in their standard care, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for IBD.

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.

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

Research has shown that resistant starch is generally safe for people. Studies indicate it can reduce gut damage and improve symptoms of inflammatory bowel disease (IBD). For example, one study found that taking about 5 grams of resistant starch daily improved gut symptoms over time. Importantly, clinical data suggests that resistant starch is well-tolerated by people with IBD. Although there aren't many studies yet, existing research supports its safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for inflammatory bowel disease?

Unlike standard treatments for inflammatory bowel disease, which often include medications like anti-inflammatory drugs or immune system suppressors, resistant starch offers a unique dietary approach. This treatment involves the oral consumption of a specially optimized type of starch that isn't digested in the stomach or small intestine, reaching the colon intact. Here, it acts as a prebiotic, potentially modifying the gut microbiome and reducing inflammation naturally. Researchers are excited because this method may offer a gentler, side-effect-free alternative to traditional pharmacological options, focusing on improving gut health through dietary intervention.

What evidence suggests that resistant starch might be an effective treatment for inflammatory bowel disease?

This trial will compare the effects of Resistant Starch with a Placebo in participants with inflammatory bowel disease (IBD). Research has shown that resistant starch can positively impact IBD. Studies suggest it may help control IBD symptoms and reduce their severity. Resistant starch alters the gut microbiome, the community of bacteria in the digestive system, leading to health benefits. When broken down in the gut, resistant starch produces helpful substances that support gut health. Although human clinical data is limited, small studies indicate that resistant starch can help manage IBD symptoms and improve gut health. ^{1 2 3 5 6}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7653724/

The effects of resistant starches on inflammatory bowel ... Our review demonstrates that resistant starch is associated with reduced histology damage in animal studies, and improvements in clinical remission in IBD ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9559413/

A randomized clinical trial using smart caps Results confirmed that while resistant starch of approximately 5 g per day improves GI symptoms at 2, 4, and 6 weeks, it did not demonstrate a ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590157524000051

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

4. bmcnutr.biomedcentral.com bmcnutr.biomedcentral.com/articles/10.1186/s40795-024-00962-7

Consumption of resistant potato starch produces changes in ... Consumption of resistant potato starch produces changes in gut microbiota that correlate with improvements in abnormal bowel symptoms: a ...

5. d-nb.info d-nb.info/1223847136/34

The effects of resistant starches on inflammatory bowel ... Human clinical data was limited but small studies dem- onstrate that RS maintain clinical remission in patients with IBD and reduces the severity of symptoms ...

6. ibdcentrebc.ca ibdcentrebc.ca/2022/06/resistant-starch/

What is resistant starch? Animal and human studies show that resistance starch may play a role in reducing intestinal damage, reducing IBD activity and supporting ...