MOx Diet for Enteric Hyperoxaluria

Overseen By David Goldfarb, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Colectomy, IBD flare, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial involves participants eating high oxalate foods and taking a specific substance to study how their bodies handle oxalate. It targets patients with IBD, post-RYGB patients with kidney stones, and healthy individuals. Researchers will collect various samples to understand oxalate processing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, healthy controls must not be on any chronic medications to participate.

Is the MOx Diet safe for humans?

The research indicates that dietary modifications, including low-oxalate diets, have been studied for their effects on urinary oxalate levels, and no significant adverse events were observed in these studies. This suggests that such dietary interventions are generally safe for humans. ^{1 2 3 4 5}

How does the MOx Diet treatment for enteric hyperoxaluria differ from other treatments?

The MOx Diet is unique because it involves a moderately high intake of oxalate, which contrasts with the common approach of a low-oxalate diet to manage hyperoxaluria. This approach may help the body adapt to higher oxalate levels, potentially reducing oxalate absorption over time. ^{1 2 3 6 7}

What data supports the effectiveness of the MOx Diet treatment for enteric hyperoxaluria?

Research shows that a low-oxalate diet can significantly reduce urinary oxalate levels, which is beneficial for people with hyperoxaluria. In one study, patients on a low-oxalate diet saw a decrease in urinary oxalate excretion, suggesting that dietary modifications can help manage this condition. ^{1 2 3 6 8}

Who Is on the Research Team?

Lama Nazzal, MD

Principal Investigator

NYU Langone Health

David Goldfarb, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Adults aged 18-80 with IBD or post-RYGB surgery, who've had a kidney stone or related event in the last three years can join. It's open to all races and genders but not for pregnant/nursing women, those with recent antibiotics use, colectomy patients, active IBD flare-ups, or significantly impaired kidney function.

Inclusion Criteria

My gender or race does not exclude me from this trial.

I have IBD or had gastric bypass surgery over 6 months ago and experienced a kidney stone event or saw a stone on an image in the last 3 years.

Exclusion Criteria

I have had a flare-up of my inflammatory bowel disease in the last 3 months.

My kidney function, measured by eGFR, is below 60 ml/min/1.73 m2.

I have not been frequently taking antibiotics for perianal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants are administered a high oxalate diet on Days 0-3 and Days 21-24, with a washout period on Days 4-7, and 250mg sodium oxalate on Days 8-20

24 days

Multiple visits for dietary administration and sample collection

Sample Collection

Participants partake in four stool collections, four 24-h urine collections, two blood collections, and four sets of colonic permeability testing

Throughout the intervention period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Moderately High Oxalate (MOx) Diet

Trial Overview The trial tests how a high oxalate diet affects individuals with Enteric Hyperoxaluria compared to healthy controls. Participants will follow specific diets and undergo stool and urine collections, blood tests, and intestinal health assessments at Weil Cornell Medicine.

How Is the Trial Designed?

Group I: Enteric Hyperoxaluria Experimental Treatment 1 Intervention

Group II: Healthy Controls Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A study of 26 commercial enteral nutrition formulas found that oxalate concentrations varied widely, from 4 to 140 mg oxalate per liter, which can lead to significant daily oxalate intake for patients requiring nutrition support.

Patients using these formulas could consume between 12 to 150 mg of oxalate per day, increasing their risk for hyperoxaluria and calcium oxalate kidney stones, especially if calcium intake is low or gastrointestinal absorption is impaired.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxalate Content of Enteral Nutrition Formulas. Penniston, KL., Palmer, EA., Medenwald, RJ., et al.[2020]

Oral calcium supplementation effectively reduced urinary oxalate excretion to normal levels in patients with enteric hyperoxaluria, as observed in a study of three patients with a history of renal stones after ileal resection.

When two patients reduced their calcium intake on their own, they experienced a return of hyperoxaluria and developed renal stones again, suggesting that maintaining an adequate dose of calcium is crucial for preventing stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral calcium supplement decreases urinary oxalate excretion in patients with enteric hyperoxaluria. Takei, K., Ito, H., Masai, M., et al.[2017]

A low-oxalate, low-fat diet significantly reduced urinary oxalate excretion in 10 patients with hyperoxaluria, from an average of 1.1 to 0.7 mmol/24 h, indicating its efficacy in managing this condition.

The study suggests that while the diet is challenging, it is manageable for patients, and emphasizes the importance of regular dietary guidance from a dietitian for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-oxalate, low-fat dietary regimen in hyperoxaluria following jejunoileal bypass. Nordenvall, B., Backman, L., Burman, P., et al.[2013]

A low-oxalate diet significantly reduced urinary oxalate levels more effectively than supplementation with vitamin B6 and magnesium in patients with idiopathic hyperoxaluria, with a median reduction of 31.1% compared to 16.0% for supplementation alone.

Combination therapy of a low-oxalate diet and supplementation did not provide additional benefits over the diet alone, indicating that dietary modification is the preferred approach for managing urinary oxalate levels in stone formers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Randomized Evaluation of Idiopathic Hyperoxaluria Treatments. Gupta, M., Gallante, B., Bamberger, JN., et al.[2022]

Increasing fluid intake in patients with bowel disease significantly improved urine volume and reduced calcium oxalate supersaturation, which is important for preventing kidney stones.

Alkali supplementation and advice to reduce oxalate absorption did not show effectiveness in lowering calcium oxalate supersaturation, indicating that these interventions may not be beneficial for stone prevention in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What treatments reduce kidney stone risk in patients with bowel disease? Bianco, J., Chu, F., Bergsland, K., et al.[2023]

A 59-year-old female patient with chronic kidney disease (CKD) due to enteric hyperoxaluria (EH) underwent combined intestine-kidney transplantation (CIKTx) after two failed kidney transplants, but experienced recurrence of EH and kidney dysfunction post-surgery.

The study suggests that kidney transplantation alone is not advisable for patients with CKD from EH due to a high risk of recurrence, highlighting the need for careful consideration of oxalate transport mechanisms in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence of Hyperoxaluria and Kidney Disease after Combined Intestine-Kidney Transplantation for Enteric Hyperoxaluria. Ekser, B., Mangus, RS., Kubal, CA., et al.[2018]

In a study of 59 children with calcium urolithiasis, plasma oxalate (POx) levels were significantly higher in those with secondary hyperoxaluria compared to healthy controls, indicating a potential link between elevated POx and kidney stone disease.

Children with calcium urolithiasis but normal urinary oxalate excretion did not show increased POx levels, suggesting that elevated POx may be associated with intestinal oxalate hyperabsorption in those with secondary hyperoxaluria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma oxalate level in pediatric calcium stone formers with or without secondary hyperoxaluria. Sikora, P., Beck, B., Zajaczkowska, M., et al.[2021]

Hyperoxaluria (HOx), which can lead to kidney stones and other complications, is often linked to low-calcium diets and can be classified into dietary, enteric, or primary types, with primary hyperoxaluria being the most severe and genetically inherited.

Advancements in early biochemical and genetic diagnosis for primary hyperoxaluria have significantly improved patient outcomes, allowing for better management and treatment strategies to prevent progression to end-stage renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Hyperoxalurias]. Marangella, M., Petrarulo, M., Bermond, F., et al.[2017]

Citations

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

Oxalate Content of Enteral Nutrition Formulas. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Oral calcium supplement decreases urinary oxalate excretion in patients with enteric hyperoxaluria. [2017]

3. Sweden pubmed.ncbi.nlm.nih.gov

Low-oxalate, low-fat dietary regimen in hyperoxaluria following jejunoileal bypass. [2013]

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

Prospective Randomized Evaluation of Idiopathic Hyperoxaluria Treatments. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

What treatments reduce kidney stone risk in patients with bowel disease? [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Recurrence of Hyperoxaluria and Kidney Disease after Combined Intestine-Kidney Transplantation for Enteric Hyperoxaluria. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Plasma oxalate level in pediatric calcium stone formers with or without secondary hyperoxaluria. [2021]

8. Italy pubmed.ncbi.nlm.nih.gov

[The Hyperoxalurias]. [2017]