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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special plant-based fiber called resistant starch can help treat inflammatory bowel disease (IBD) by improving gut health. Researchers aim to determine if this starch, tailored for each person, might address the root cause of IBD and support a healthier gut microbiome. Participants will take either this resistant starch or a placebo (a harmless substitute) daily for about five months. The trial seeks children with a recent diagnosis of ulcerative colitis or Crohn's disease who are already responding well to their current treatments.

As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options 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 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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that resistant starch benefits gut health by producing important acids that support the gut. Studies indicate that resistant starch acts as a prebiotic, feeding beneficial bacteria in the intestines.

However, its safety for treating inflammatory bowel disease (IBD) remains unclear. Some research suggests potential benefits, but more information is needed to confirm its safety for people with IBD.

In a clinical trial testing various amounts of resistant starch, researchers observed its effects on the digestive system. The study found no serious negative effects, suggesting that resistant starch is generally safe.

While resistant starch isn't specifically approved for IBD, its use in other situations hasn't shown major safety issues. Individual responses can vary, so results may differ from person to person. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Resistant starch is unique because it offers a dietary approach to managing inflammatory bowel disease (IBD), unlike conventional treatments such as anti-inflammatory drugs or immunosuppressants. This starch is not fully digested in the small intestine, allowing it to reach the colon where it can promote beneficial gut bacteria and produce short-chain fatty acids, potentially reducing inflammation. Researchers are excited about resistant starch because it represents a non-pharmaceutical option that could improve gut health naturally, with fewer side effects.

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

Research has shown that resistant starch, which participants in this trial may receive, may help alleviate symptoms of inflammatory bowel disease (IBD). Some studies suggest it can reduce intestinal damage and prolong symptom-free periods. It achieves this by altering the gut microbiome—the community of bacteria in the intestines—and producing substances that support gut health. In small studies, resistant starch has been linked to fewer and less severe symptoms. While further research is necessary, these findings suggest it could be a promising option for those with IBD. ^{1 6 7 8 9}

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

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10819196/

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

7. sciencedirect.com sciencedirect.com/science/article/pii/S1756464622001645

Health benefits of resistant starch: A review of the literature Resistant starch may improve carbohydrate and lipid metabolism and body weight. Resistant starch as a prebiotic improves intestinal function.

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.987216/full

The gastrointestinal and microbiome impact of a resistant ... A randomized clinical trial evaluated the GI impact of varying doses of a novel resistant starch blend (RSB) with smart cap monitoring.

9. mdpi.com mdpi.com/1422-0067/26/16/7753

Resistant Starch and Microbiota-Derived Secondary ... The excessive intake of rapidly digestible starches has been associated with adverse effects on metabolic health and intestinal barrier function, including ...