Resistant Starch for Crohn's Disease

(PROMOTE Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Eastern Ontario

Must be taking: Anti-TNFa monoclonal antibodies

Must not be taking: Immunomodulating, Biological medications

Disqualifiers: Diabetes, Illicit drug use, Pregnancy, others

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special type of plant starch, known as Resistant Starch, can improve gut health in children with Crohn's Disease. The researchers seek to discover if this starch can increase certain beneficial bacteria that produce butyrate, a substance that supports gut health. Participants will consume either this resistant starch or a placebo (a look-alike with no active ingredient) daily for 48 weeks. Children with Crohn's Disease affecting specific gut areas and who are already on certain medications may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance gut health in children with Crohn's Disease.

Do I need to stop my current medications for the trial?

The trial requires participants to be on infliximab or adalimumab for Crohn's Disease and not to change their medical treatment for at least a month before and during the trial. So, you will need to continue your current medication if it's one of these.

What prior data suggests that this resistant starch is safe for humans?

Research has shown that resistant starch is generally safe for consumption. Studies have found it can improve gut health by reducing inflammation and alleviating symptoms of inflammatory bowel disease (IBD). Animal research also suggests it might aid in healing the gut lining.

In one study, consuming about 5 grams of resistant starch daily eased stomach issues over several weeks, with no serious side effects. Another study found that resistant potato starch could lower histamine levels in the blood, potentially helping with some allergies, without affecting the enzymes that break down histamine.

Overall, resistant starch appears safe for people, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Crohn's disease, which often include anti-inflammatory drugs, immunosuppressants, and biologics, resistant starch offers a unique approach by promoting gut health through dietary modification. Researchers are excited about resistant starch because it acts as a prebiotic, feeding beneficial gut bacteria and potentially reducing inflammation from the inside out. This method is non-invasive and based on optimizing the microbiome, which could lead to fewer side effects and a more natural way to manage the condition over time.

What evidence suggests that resistant starch might be an effective treatment for Crohn's disease?

Research has shown that resistant starch, which participants in this trial may receive, can aid people with Crohn's disease by enhancing gut health. Studies have found that it reduces gut damage, a sign of inflammation. Resistant starch also alters gut bacteria, increasing those that produce butyrate, a substance that supports gut health. It can also alleviate unusual bowel symptoms, common in Crohn's disease. These benefits make resistant starch a promising option for managing symptoms. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for children with Crohn's Disease, a type of Inflammatory Bowel Disease. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and may be required to have a diagnosis of Crohn's Disease.

Inclusion Criteria

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

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

I am between 8 and 16 years old.

Exclusion Criteria

Current illicit drug or alcohol dependence

Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay

I am unable or unwilling to sign the consent form.

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 for 48 weeks, with optimization at 24 weeks

48 weeks

Visits at baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistant Starch

Trial Overview The PROMOTE Trial is testing if a special plant-based resistant starch can increase good microbes in the gut that help reduce inflammation when given alongside standard anti-TNFα therapy for Crohn's Disease in children.

How Is the Trial Designed?

Group I: Resistant Starch Active Control 1 Intervention

Once daily oral consumption of either 7.5g/m2 or 5.0g/m2 (body surface area) of a resistant starch for 48 weeks that is individually optimized at 24 weeks.

Group II: Placebo Placebo Group 1 Intervention

Once daily oral consumption of a readily digestible food-grade cornstarch that resembles the study product in appearance, smell and taste for 48 weeks

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

Supplementing weaned pig diets with at least 0.5% resistant potato starch (RPS) improved fecal scores, indicating better gut health, without negatively affecting growth performance over a 28-day period.

RPS supplementation also lowered digesta pH and increased total volatile fatty acid concentrations in the cecum, suggesting enhanced fermentation and gut function, while maintaining similar visceral organ weights and nutrient digestibility compared to control diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding a diet containing resistant potato starch influences gastrointestinal tract traits and growth performance of weaned pigs. Heo, JM., Agyekum, AK., Yin, YL., et al.[2014]

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]

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]

A clinical trial with varying doses of a novel resistant starch blend (RSB) showed that consuming around 5 g of resistant starch daily can improve gastrointestinal symptoms over a period of 6 weeks, particularly reducing diarrhea scores.

Higher doses of the RSB blend were linked to reduced sleep disturbances and changes in gut microbiome composition, specifically increasing beneficial bacteria like Faecalibacterium and Akkermansia, which are associated with better human health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The gastrointestinal and microbiome impact of a resistant starch blend from potato, banana, and apple fibers: A randomized clinical trial using smart caps. Hanes, D., Nowinski, B., Lamb, JJ., et al.[2022]

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/S1756464623003407

Resistant potato starch supplementation reduces serum ... Resistant potato starch (RPS) supplementation decreases serum histamine levels. RPS does not influence histamine-degrading enzymes.

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. 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.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322008511

Resistant Starch: Promise for Improving Human Health Recent and ongoing studies address the impact of digestion-resistant starches on the prevention and control of chronic human diseases.

7. mdpi.com mdpi.com/2072-6643/14/3/721

Additional Resistant Starch from One Potato Side Dish per ... Intake of one potato-based side dish per day resulted in modest changes in gut microbiota composition and diversity, compared to isocaloric intake of refined ...