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Microbial Therapy
Fecal Microbiota Transplantation for Kidney Stones (FMT IND Trial)
Phase < 1
Waitlist Available
Led By Joshua Stern, MD
Research Sponsored by Joshua Stern
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recent medical history of USD with >60% calcium-oxalate stones confirmed by stone analysis
Recurrent urinary stone formers with a stone event in the preceding 24 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 3, 4, and 5
Awards & highlights
FMT IND Trial Summary
This trial will study whether or not Microbial Transplant Therapy (MTT) is an effective treatment for recurrent kidney stones.
Who is the study for?
This trial is for adults aged 18-70 with a history of kidney stones, specifically those with high levels of calcium or oxalate in their urine. Participants must have had a stone event within the last two years and be able to perform study tasks like urine collection. Exclusions include individuals on dialysis, recent chemotherapy patients, those who've had certain surgeries or gastrointestinal conditions, pregnant women, and others with specific health issues.Check my eligibility
What is being tested?
The trial is testing Microbial Transplant Therapy (MTT) against a placebo to see its effects on urinary factors related to kidney stone formation. Participants will either receive MTT or an inactive substance without knowing which one they're getting.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include digestive discomforts such as bloating or changes in bowel habits due to the introduction of new microbes into the gut from MTT.
FMT IND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent kidney stones were mostly calcium-oxalate.
Select...
I have had kidney stones again within the last 2 years.
FMT IND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to fecal transplant (baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to fecal transplant (baseline)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in 24 hour urinary calcium concentration
Changes in 24 hour urinary oxalate concentration
Proportion of participants with an adverse event
Secondary outcome measures
Metagenomic changes to subject microbiota post-MTT
Metagenomic changes to subject microbiota pre-MTT
FMT IND Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Hyperoxaluric groupExperimental Treatment1 Intervention
Treatment group based on 24 hour urine analysis showing oxalate >40 mg/day.
Group II: Hypercalciuric GroupExperimental Treatment1 Intervention
Treatment group based on 24 hour urine analysis showing urinary calcium >225 mg/day.
Group III: Control group HyperoxaluriaPlacebo Group1 Intervention
Control group enrolling patients with hyperoxaluria
Group IV: Control group HypercalciuriaPlacebo Group1 Intervention
Control group enrolling patients with hypercalciuria
Find a Location
Who is running the clinical trial?
Litholink CorporationUNKNOWN
Joshua SternLead Sponsor
University of MinnesotaOTHER
1,378 Previous Clinical Trials
1,588,473 Total Patients Enrolled
1 Trials studying Kidney Stones
43 Patients Enrolled for Kidney Stones
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old.I agree to phone calls to check on my health and side effects.I have been diagnosed with metabolic syndrome.I have had chemotherapy in the past year.I have not taken antibiotics in the last 3 months.Your urinary oxalate level is 80 mg/d or higher.I do not have an active stomach or intestine infection.Your kidney function, measured by eGFR, is normal or higher than 60.I am currently receiving dialysis.I have been taking potassium citrate, thiazides, or proton pump inhibitors in the last 6 months.I need to keep taking antibiotics or expect to start them soon.I have been diagnosed with colonic polyps.I have had kidney stones again within the last 2 years.My parathyroid hormone levels are not between 11 - 51 pg/ml.I have or might have a severely enlarged colon or a blockage in my small intestine.Your 24-hour urine test shows high levels of calcium or oxalate.My recent kidney stones were mostly calcium-oxalate.I have had my entire colon removed or weight loss surgery.You are not expected to live for more than 6 months.You have a history of severe allergic reactions to food.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.You have signs of autoimmune disease.I am currently receiving intensive treatment for cancer.Your parathyroid hormone (PTH) levels are not between 11 and 51 pg/ml.I have received a solid organ transplant.I have difficulty swallowing pills.I have been diagnosed with inflammatory bowel disease.I have never used FMT or microbiome products before this study.My kidney function is reduced with a GFR below 60.I haven't had major stomach or intestine surgery in the last 3 months.I need pancreatic enzyme supplements.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperoxaluric group
- Group 2: Hypercalciuric Group
- Group 3: Control group Hyperoxaluria
- Group 4: Control group Hypercalciuria
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in the trial still open to volunteers?
"As indicated on clinicaltrials.gov, this research study is not recruiting patients at present time. It was initially posted on September 1st of last year and the most recent update happened in August of this year. Nevertheless, 107 other trials are actively looking for volunteers as we speak."
Answered by AI
Is this study open to individuals younger than 25 years of age?
"Patients of legal age (over 18) and under 69 are being sought out for this medical trial."
Answered by AI
What qualifications are needed for participants to join this experiment?
"This medical study is seeking 36 individuals suffering from kidney stones, aged between 18-69 years old. Eligible patients must meet the following criteria: men or women over 18 and below 70, a recent history of urolithiasis showing more than 60% calcium oxalate stones, 24 hour urine concentration greater than 225 mg/day or urinary oxalate above 40mg/day, willing to give informed consent for participation in the trial's activities - including visits, 24-hour urine collection and serial stool collections - not involved with another interventional USD clinical trial and open to telephone follow ups regarding safety issues and adverse events."
Answered by AI
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