What side effects are associated with this type of intervention?

Common treatments for Enteric Hyperoxaluria, such as sodium oxalate, can have several side effects. These may include gastrointestinal discomfort, such as bloating, gas, and diarrhea, due to increased colonic permeability. Additionally, there may be an increased risk of kidney stones due to higher oxalate levels in the urine. Patients might also experience changes in bowel habits and potential nutrient malabsorption. It is important to monitor these side effects and adjust treatment as necessary under medical supervision.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for the treatment of Enteric Hyperoxaluria in the provided context. The trial involving sodium oxalate focuses on its impact on oxalate metabolism and excretion, as well as colonic permeability. Generally, treatments for Enteric Hyperoxaluria may involve dietary modifications, calcium supplements, and probiotics to reduce oxalate absorption and promote gut health.

What other types of research exist?

Promising novel alternatives to Sodium Oxalate for Enteric Hyperoxaluria patients include the use of probiotics such as Oxalobacter formigenes, which can degrade oxalate in the gut, and the administration of calcium supplements to bind oxalate in the intestines, reducing its absorption. Additionally, dietary modifications to reduce oxalate intake and the use of bile acid sequestrants to decrease colonic permeability and oxalate absorption are also being explored as effective treatments.

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MOx Diet for Enteric Hyperoxaluria

Q: What is the mechanism of action of this treatment?

Enteric Hyperoxaluria is often managed by dietary modifications, calcium supplements, and probiotics. Dietary changes, such as a low-oxalate diet, reduce oxalate intake. Calcium supplements bind oxalate in the gut, forming insoluble calcium oxalate that is excreted in the stool, thereby reducing oxalate absorption. Probiotics, like Oxalobacter formigenes, degrade oxalate in the gut, decreasing its absorption. These treatments are crucial as they help lower urinary oxalate levels, reducing the risk of kidney stones and other complications associated with hyperoxaluria.

N/A

Recruiting

Led By David Goldfarb, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Subjects > 18 years and < 80 years of age

Be older than 18 years old

Must not have

Patients with estimated glomerular filtration rates (eGFR) < 60 ml/min/1.73 m2 calculated by the CKD-EPI equation measured anytime within the preceding year

Patients with perianal disease usually receive recurrent antibiotics and, therefore, will be excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2-3

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort due to the high oxalate diet such as bloating or constipation. There might also be an increased risk of forming new kidney stones during the study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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I have not been frequently taking antibiotics for perianal disease.

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I have had all or part of my colon removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2-3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2-3

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2-3 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Urinary Oxalate Levels (UOx)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enteric HyperoxaluriaExperimental Treatment1 Intervention

Group II: Healthy ControlsActive Control1 Intervention

0 / 4Eligibility criteria met

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

Enteric Hyperoxaluria is often managed by dietary modifications, calcium supplements, and probiotics. Dietary changes, such as a low-oxalate diet, reduce oxalate intake. Calcium supplements bind oxalate in the gut, forming insoluble calcium oxalate that is excreted in the stool, thereby reducing oxalate absorption. Probiotics, like Oxalobacter formigenes, degrade oxalate in the gut, decreasing its absorption. These treatments are crucial as they help lower urinary oxalate levels, reducing the risk of kidney stones and other complications associated with hyperoxaluria.