BridgeMD
New treatment option for Kidney Stones
Official title Fecal Microbiota Transplantation in Kidney Stone Patients
ClinicalTrials.gov ID: NCT05516472
What this study is testing
What is Microbial Transplant Therapy?
Microbial Transplant Therapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for kidney stones.
Also referred to as fecal transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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 treatment USD clinical trial
- Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60.
- 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 people need to take antibiotics unexpectedly during the trial, they are excluded if they have already taken the fecal material transplant; if not, they can...
- 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. people 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.
- people will be excluded if they have chronic kidney disease defined as GFR (Glomerular Filtration Rate) less than 60.
- people with urinary oxalate greater than or equal to 80 mg/d will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Park City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Park City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.