RecruitingEarly Phase 1NCT05516472

Fecal Microbiota Transplantation in Kidney Stone Patients

Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)

Sponsor

Joshua Stern

Enrollment

36 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Kidney Stones

Summary

The purpose of this study is to measure the impact of Microbial Transplant Therapy (MTT) on 24-hour urine parameters in recurrent hypercalciuric and hyperoxaluric kidney stone formers.

Eligibility

Min Age: 18 YearsMax Age: 69 Years

Inclusion Criteria8

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.
-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 Criteria30

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