Ignite Creation Date:
2024-05-06 @ 9:06 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02903472
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2016-09-13
Brief Title:
Gastrointestinal and Urinary Tract Microbiome After SCI
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Gastrointestinal GI and Urinary Tract UT Microbiome MICRO After Spinal Cord Injury SCI
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Changes in the GI microbiota andor metabolomics have been linked to evolving transformations in immune system function and infection rates in experimental SCI in animal models A recent study involving chronic survivors of SCI show distinct GI microbiome changes in comparison to healthy controls GI microbial metabolism of dietary components has been causally linked to various health conditions such as cardiovascular disease infections which is an ongoing concern for chronic SCI survivors It is probable that alterations of GI microbiota are established acutely after SCI and could subsequently alter medical care and impact health outcomes for people living with SCI
This project is a pilot study to describe any changes in the GI and urinary tract microbiota as they appear over the first year after SCI When available data on factors other than SCI that may impact change in the gut microbiome after SCI will also be noted including
the level and severity of SCI
the time since SCI
the persons immune profile
the antibiotic regimen of the individual and time since antibiotic administration
the incidence and type of infections after SCI and
the persons diet or activities after SCI
This project is a pilot study to describe any changes in the GI and urinary tract microbiota as they appear over the first year after SCI When available data on factors other than SCI that may impact change in the gut microbiome after SCI will also be noted including
the level and severity of SCI
the time since SCI
the persons immune profile
the antibiotic regimen of the individual and time since antibiotic administration
the incidence and type of infections after SCI and
the persons diet or activities after SCI
Detailed Description:
Study 1 - Acute to first year after SCI
The investigators wish to recruit 4 types of SCI participants 8 tetraplegic motor complete SCI participants 8 tetraplegic motor incomplete SCI 8 paraplegic motor complete SCI and 8 paraplegic motor incomplete SCI This totals 32 participants
The investigators will non-invasively collect small 1 gram stool and urine 1 ml samples from people who have suffered an acute SCI and have been admitted to their hospital for care and treatment of their injury
The investigators will track changes in the microbiota microbiome and metabolome within the gastrointestinal GI tract of people after acute spinal cord injury SCI through the non-invasive collection of a small stool sample during normal bowel routines at baseline within the first week after SCI Subsequent samples would be obtained in the same non-invasive nature at approximately 1 3 6 and 12 months after SCI as part of any daily in-patient or at home outpatient bowel routine The stool samples will be processed for genomic analysis to identify GI bacterial species and any changes in an individuals GI microbiota andor dysbiosis during the first year after SCI As SCI increases the incidence and prevalence of urinary tract infections UTIs the investigators will track alteration within the microbiota of the urinary tract to ascertain whether there are links in the bacterial taxa between the GI system and urinary tract
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Study 2 - Chronic
This study will attempt to recruit 20 chronic SCI participants with or without recurrent infections eg UTI skin or systemic to ascertain whether there is a correlation between a dysbiotic microbiota presentation and recurrent infections
A small stool or urine sample will be obtained at home by participants and subsequently collected for genomic analysis during a persons routine outpatient clinic visit
All replicate data 3 samples per individual at 3 different time points - 1 6 and 12 months post baseline visit from chronic participants would be matched as much as possible for age gender diet type of SCI time since SCI activity and should only differ in terms of recurrent infections and antibiotic prescriptions The goal here would be to characterize any gut microbiota differences between the two disparate groups The data may guide the development of future studies to investigate treatment options During chronic SCI many recurrent infections are UTIs thus the investigators will also monitor differences between the two group in the microbiota and metabolomics of the urinary tract
The investigators wish to recruit 4 types of SCI participants 8 tetraplegic motor complete SCI participants 8 tetraplegic motor incomplete SCI 8 paraplegic motor complete SCI and 8 paraplegic motor incomplete SCI This totals 32 participants
The investigators will non-invasively collect small 1 gram stool and urine 1 ml samples from people who have suffered an acute SCI and have been admitted to their hospital for care and treatment of their injury
The investigators will track changes in the microbiota microbiome and metabolome within the gastrointestinal GI tract of people after acute spinal cord injury SCI through the non-invasive collection of a small stool sample during normal bowel routines at baseline within the first week after SCI Subsequent samples would be obtained in the same non-invasive nature at approximately 1 3 6 and 12 months after SCI as part of any daily in-patient or at home outpatient bowel routine The stool samples will be processed for genomic analysis to identify GI bacterial species and any changes in an individuals GI microbiota andor dysbiosis during the first year after SCI As SCI increases the incidence and prevalence of urinary tract infections UTIs the investigators will track alteration within the microbiota of the urinary tract to ascertain whether there are links in the bacterial taxa between the GI system and urinary tract
------------------------------------------------------------------------------
Study 2 - Chronic
This study will attempt to recruit 20 chronic SCI participants with or without recurrent infections eg UTI skin or systemic to ascertain whether there is a correlation between a dysbiotic microbiota presentation and recurrent infections
A small stool or urine sample will be obtained at home by participants and subsequently collected for genomic analysis during a persons routine outpatient clinic visit
All replicate data 3 samples per individual at 3 different time points - 1 6 and 12 months post baseline visit from chronic participants would be matched as much as possible for age gender diet type of SCI time since SCI activity and should only differ in terms of recurrent infections and antibiotic prescriptions The goal here would be to characterize any gut microbiota differences between the two disparate groups The data may guide the development of future studies to investigate treatment options During chronic SCI many recurrent infections are UTIs thus the investigators will also monitor differences between the two group in the microbiota and metabolomics of the urinary tract
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None