Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330246
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-19
Brief Title:
O Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Oxalobacter Formigenes Colonization in Calcium Oxalate Kidney Stone Formers
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease
The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes
Participants will
ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time
collect urine blood and stool samples during the fixed diets
ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes
The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes
Participants will
ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time
collect urine blood and stool samples during the fixed diets
ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes
Detailed Description:
In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate before and after inducing colonization with the gut bacteria Oxalobacter formigenes in individuals with a history of calcium oxalate kidney stones not already colonized with Oxalobacter formigenes
Screening and Pre-colonization phase Between the University of Alabama at Birmingham UAB and the University of Texas Southwestern Medical Center UTSW the study will enroll 40 individuals with a history of idiopathic calcium oxalate kidney 20 males20 females Screening will include stool colonization testing blood complete metabolic profile 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements
Participants will ingest a low-oxalate 60 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
After a wash-out period of at least 1 week participants will ingest a moderately high-oxalate 250-300 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
Colonization and Post-colonization phase Participants will be colonized with Oxalobacter formigenes by ingesting a freshly thawed paste of live bacterial preparation of O formigenes They will collect a stool sample 1 week later to assess if colonization occured
After confirmation of successful colonization participants will ingest a low-oxalate 60 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
After a wash-out period of at least 1 week participants will ingest a moderately high-oxalate 250-300 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
Follow-up phase Participants will be followed up every 6 months to assess sustainability of colonization provide a stool sample and answer a simple questionnaire A 24-hr urine collection will be requested once a year after colonization on the same moderately high oxalate diet diet after 2 days of dietary equilibration
Screening and Pre-colonization phase Between the University of Alabama at Birmingham UAB and the University of Texas Southwestern Medical Center UTSW the study will enroll 40 individuals with a history of idiopathic calcium oxalate kidney 20 males20 females Screening will include stool colonization testing blood complete metabolic profile 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements
Participants will ingest a low-oxalate 60 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
After a wash-out period of at least 1 week participants will ingest a moderately high-oxalate 250-300 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
Colonization and Post-colonization phase Participants will be colonized with Oxalobacter formigenes by ingesting a freshly thawed paste of live bacterial preparation of O formigenes They will collect a stool sample 1 week later to assess if colonization occured
After confirmation of successful colonization participants will ingest a low-oxalate 60 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
After a wash-out period of at least 1 week participants will ingest a moderately high-oxalate 250-300 mgday fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration as well as one fasted blood sample on the last morning
Follow-up phase Participants will be followed up every 6 months to assess sustainability of colonization provide a stool sample and answer a simple questionnaire A 24-hr urine collection will be requested once a year after colonization on the same moderately high oxalate diet diet after 2 days of dietary equilibration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK137784 | NIH | None | httpsreporternihgovquickSearchR01DK137784 |