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

45 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Resistant Starch for Crohn's Disease?

Research shows that resistant potato starch (RPS) can positively influence gut health by altering the gut microbiome and increasing beneficial compounds like butyrate, which may help with inflammation. Although these studies were not specifically on Crohn's Disease, they suggest potential benefits for gut-related conditions. ^{1 2 3 4 5}

Is resistant starch safe for human consumption?

Resistant starch is generally safe for humans and can have mild laxative effects, increasing stool weight and frequency. It is broken down in the gut, mainly in the colon, and may affect gut bacteria and immune response, but long-term effects can vary. ^{3 4 6 7 8}

How does resistant starch treatment differ from other treatments for Crohn's Disease?

Resistant starch (RS), particularly from potatoes, is unique because it is not digested in the stomach and small intestine, reaching the colon where it can positively influence gut bacteria and immune responses. Unlike typical medications for Crohn's Disease, which often target inflammation directly, RS works by altering the gut microbiome and may improve gut health over time. ^{3 4 5 9 10}

What is the purpose of this trial?

To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

References

1. 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]

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. 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]

4. 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]

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

Feeding a diet containing resistant potato starch influences gastrointestinal tract traits and growth performance of weaned pigs. [2014]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Intestinal transport and fermentation of resistant starch evaluated by the hydrogen breath test. [2013]

10. Switzerland 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. [2022]