RECRUITING

Fecal Microbiota Transplantation in Kidney Stone Patients

Conditions

Kidney Stones microbial transplant therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-10

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05516472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 69 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Women and men age greater than 18 and less than 70 * Recent medical history of USD with greater than 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.	* 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 11 - 51 pg/ml will be excluded. * Patient diagnosed secondary hyperparathyroidism. Any patient with a PTH outside the range of 11 - 51 pg/ml will be excluded. * All patients requiring pancreatic enzyme replacement will be excluded. * All patients diagnosed with colonic polyps on a diagnostic colonoscopy 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

Inclusion Criteria

Exclusion Criteria

* Women and men age greater than 18 and less than 70
* Recent medical history of USD with greater than 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.

* 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 11 - 51 pg/ml will be excluded.
* Patient diagnosed secondary hyperparathyroidism. Any patient with a PTH outside the range of 11 - 51 pg/ml will be excluded.
* All patients requiring pancreatic enzyme replacement will be excluded.
* All patients diagnosed with colonic polyps on a diagnostic colonoscopy 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

Contacts and Locations

Study Contact

Daniel Del Valle, MS

CONTACT

(801) 507-9421

daniel.delvalle@imail.org

Joshua Stern, MD

CONTACT

(435) 658-7400

joshua.stern@imail.org

Principal Investigator

Joshua Stern, MD

PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Study Locations (Sites)

Park City Hospital

Park City, Utah, 84060

United States

Collaborators and Investigators

Sponsor: Joshua Stern

Joshua Stern, MD, PRINCIPAL_INVESTIGATOR, Intermountain Health Care, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10

Study Completion Date2027-03

Study Record Updates

Study Start Date2024-10-10

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

microbial transplant therapy
kidney stones

Additional Relevant MeSH Terms

Kidney Stones