Fecal Microbiota Transplantation in Kidney Stone Patients

Launched by JOSHUA STERN · Aug 23, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called Microbial Transplant Therapy (MTT) can help people who frequently develop kidney stones made of calcium and oxalate. The main goal is to see how this therapy affects certain measurements in urine collected over 24 hours. The study is currently looking for participants aged 18 to 69 who have a history of kidney stones and meet specific health criteria.

To join the trial, participants should have had calcium-oxalate stones confirmed through analysis and should produce a certain amount of calcium or oxalate in their urine. Those interested will need to participate in regular visits and collect samples of their urine and stool. It's important to note that some individuals, such as those with specific health conditions or those currently taking certain medications, will not be eligible. Participants can expect close monitoring and follow-ups to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Women and men age greater than or equal to 18 and less than 70
• • Recent medical history of USD with greater than or equal to 50% calcium-oxalate stones. All patients will have urinary stone disease confirmed by stone analysis. The study will include patients with either stones extracted by urological intervention or spontaneously passed and collected stones.
• • 24-hour urinary calcium concentration greater than 225 mg/day or urinary oxalate greater than 40 mg/day
• • Able to give informed consent.
• • Willing to undergo telephone follow-up to assess for safety and adverse events
• • Willing and able to participate in the study requirements, including study visits, 24-hour urine collection and serial stool collection
• • Not actively participating in another interventional USD clinical trial
• • Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60.
• Exclusion Criteria:
• * Presence of three features of metabolic syndrome as defined by the NIH to have 3 or more of the following conditions:
• • Large waist - A waistline that measures at least 35 inches (89 centimeters) for women and 40 inches (102 centimeters) for men
• • High triglyceride level - 150 milligrams per deciliter (mg/dL), or 1.7 millimoles per liter (mmol/L), or higher of this type of fat found in blood
• • Reduced good or HDL cholesterol - Less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women of high-density lipoprotein (HDL) cholesterol
• • Increased blood pressure - 130/85 millimeters of mercury (mm Hg) or higher
• • Elevated fasting blood sugar - 100 mg/dL (5.6 mmol/L) or higher
• • Presence of features of autoimmunity
• • Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
• • Diagnosis of inflammatory bowel disease
• • Patient diagnosed with primary hyperparathyroidism. Any patient with a PTH outside the range of 15 - 65 pg/ml will be excluded.
• • Patient diagnosed secondary hyperparathyroidism. Any patient with a PTH outside the range of 15 - 65 pg/ml will be excluded.
• • All patients requiring pancreatic enzyme replacement will be excluded.
• • Patient with ongoing dialysis treatment
• • Received chemotherapy treatment in the last 1 year
• • Treatment with antibiotics within 3 months of study entry. If subjects need to take antibiotics unexpectedly during the trial, they are excluded if they have already taken the fecal material transplant; if not, they can re-enroll in 3 months.
• • Patients taking potassium citrate, thiazides, or proton pump inhibitors in the last 6 months
• • Women who are pregnant or breast-feeding or planning to get pregnant during the time of the study.
• • Inability (e.g. dysphagia) to or unwilling to swallow capsules. Subjects with Grade greater than or equal to 2 dysphagia- as per Current Terminology for Common Adverse Events (CTCAE v 5.0) will be excluded.
• • Active gastrointestinal infection at time of enrollment
• • Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks
• • Known or suspected toxic megacolon and/or known small bowel ileus
• • History of total colectomy or bariatric surgery
• • Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy
• • Expected life expectancy less than 6 months
• • Previous FMT or microbiome-based products at any time excluding this study
• • Patients with a history of severe anaphylactic or anaphylactoid food allergy
• • Solid organ transplant recipients (all patients with a history of solid organ transplant will be excluded).
• • A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
• • Subjects will be excluded if they have chronic kidney disease defined as GFR (Glomerular Filtration Rate) less than 60.
• • Subjects with urinary oxalate greater than or equal to 80 mg/d will be excluded