Fecal Microbiota Transplantation in Kidney Stone Patients

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joshua Stern
• Collaborators: Albert Einstein College of Medicine; Litholink Corp; University of Minnesota

Criteria

Inclusion Criteria:

1. Women and men age >18 and <70

2. Recent medical history of USD with >60% calcium-oxalate stones

3. 24-hour urinary calcium concentration >225 mg/day or urinary oxalate >40 mg/day

4. Able to give informed consent.

5. Willing to undergo telephone follow-up to assess for safety and adverse events

6. Willing and able to participate in the study requirements, including study visits, 24-hour urine collection and serial stool collection

7. Not actively participating in another interventional USD clinical trial

Exclusion Criteria:

1. Presence of features of metabolic syndrome

2. Presence of features of autoimmunity

3. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy

4. Diagnosis of inflammatory bowel disease

5. Patient diagnosed with primary hyperparathyroidism

6. Patient diagnosed secondary hyperparathyroidism

7. Patient with ongoing dialysis treatment

8. Received chemotherapy treatment in the last 1 year

9. Treatment with antibiotics within 4 months of study entry

10. Patients taking potassium citrate, thiazides, or proton pump inhibitors in the last 6 months

11. Women who are pregnant or breast-feeding or planning to get pregnant during the time of the study.

12. Inability (e.g. dysphagia) to or unwilling to swallow capsules

13. Active gastrointestinal infection at time of enrollment

14. Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks

15. Known or suspected toxic megacolon and/or known small bowel ileus

16. History of total colectomy or bariatric surgery

17. Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy

18. Expected life expectancy < 6 months

19. Previous FMT or microbiome-based products at any time excluding this study

20. Patients with a history of severe anaphylactic or anaphylactoid food allergy

21. Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection

22. 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.