What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) that aim to alter gut microbiota and reduce uremic toxins include dietary modifications, phosphate binders, and probiotics. Dietary modifications can sometimes lead to malnutrition if not properly managed. Phosphate binders may cause gastrointestinal side effects such as constipation, diarrhea, and nausea. Probiotics are generally well-tolerated but can occasionally cause bloating and gas. These treatments require careful monitoring to balance efficacy and minimize adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Kidney Disease (CKD), primarily focusing on managing symptoms and slowing disease progression. These include medications like angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) to control blood pressure and reduce proteinuria. Additionally, sodium-glucose co-transporter-2 (SGLT2) inhibitors, such as dapagliflozin, have been approved for their renal protective effects. While specific FDA approvals for treatments that alter gut microbiota to reduce uremic toxins, like resistant potato starch, are not well-documented, the concept is being explored in clinical trials to potentially offer a novel adjunctive therapy for CKD management.

What other types of research exist?

Promising alternatives to Resistant Potato Starch for CKD patients include: <ol> <li>Inulin: A prebiotic fiber that promotes beneficial gut bacteria and has been shown to reduce uremic toxins.</li> <li></li> </ol> Fructooligosaccharides (FOS): These prebiotics enhance gut microbiota and may help in reducing uremic toxins. 3. Galactooligosaccharides (GOS): Another prebiotic that supports gut health and could be beneficial in CKD. 4. Probiotic supplements: Specific strains like Lactobacillus and Bifidobacterium can improve gut microbiota and reduce uremic toxins. 5. Synbiotics: Combination of prebiotics and probiotics that work synergistically to enhance gut health and reduce uremic toxins.

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Resistant Starch for Chronic Kidney Disease (ReSPECKD Trial)

N/A

Waitlist Available

Led By Dylan Mackay, PhD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between endpoints of each experimental period (week 8 to week 18)

Summary

This trial tests if taking Resistant Potato Starch (RPS) can help patients with Chronic Kidney Disease by improving their gut bacteria and reducing harmful blood toxins. A high resistant starch diet has shown to slow down CKD progression and reduce oxidative stress and inflammation in rats.

Who is the study for?

Adults over 18 with Chronic Kidney Disease (CKD) and an eGFR <15 mL/min/1.73m^2, who can read English and consent to study requirements. Women must use birth control if of child-bearing potential. Excludes those with uncontrolled diabetes (A1C > 10%), cognitive impairments, allergies to potatoes or corn, severe gastrointestinal conditions, severe anemia, recent antibiotic use, or on dialysis.

What is being tested?

The trial is testing whether resistant potato starch can reduce uremic toxins by changing gut bacteria in CKD patients compared to standard corn starch. Participants will add this to their usual CKD care regimen to see if it improves symptoms and delays the need for dialysis.

What are the potential side effects?

Potential side effects may include digestive issues like bloating or gas due to increased fiber intake from the resistant potato starch. Allergic reactions are possible but only in those with known allergies to potatoes or corn.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between endpoints of each experimental period (week 8 to week 18)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between endpoints of each experimental period (week 8 to week 18)

This trial's timeline: 3 weeks for screening, Varies for treatment, and between endpoints of each experimental period (week 8 to week 18) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in blood uremic toxin, indoxyl sulphate, between treatments

Change in blood uremic toxin, p-cresyl sulphate, between treatments

Secondary study objectives

Change in alpha diversity of the gut microbiome between treatments

Change in beta diversity of the gut microbiome between treatments

Change in differential abundance in the gut microbiome between treatments

+2 more

Other study objectives

Change in Hemoglobin A1c

Change in body weight

Change in serum glucose

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Resistant Potato StarchExperimental Treatment1 Intervention

15g RPS mixed with water will be consumed twice per day during intervention

Group II: Corn StarchPlacebo Group1 Intervention

15 g corn starch mixed with water will be consumed twice per day during intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) often include dietary interventions that target the gut microbiota to reduce uremic toxins. For example, Resistant Potato Starch (RPS) acts as a prebiotic, altering the gut microbiota composition. This change can decrease the production and absorption of harmful uremic toxins, which accumulate due to impaired kidney function. By reducing these toxins, such treatments can alleviate symptoms, improve quality of life, and potentially slow the progression of CKD, delaying the need for dialysis.

Exploring series of multivariate censored temporal data through fuzzy coding and correspondence analysis.Creatinine filtration, secretion and excretion during progressive renal disease. Modification of Diet in Renal Disease (MDRD) Study Group.