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Gastrointestinal and Urinary Tract Microbiome After SCI

2 februari 2021 uppdaterad av: Matthias Walter, University of British Columbia

Gastrointestinal (GI) and Urinary Tract (UT) Microbiome (MICRO) After Spinal Cord Injury (SCI)

Changes in the GI microbiota and/or 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 person's immune profile,
  • the antibiotic regimen of the individual and time since antibiotic administration,
  • the incidence and type of infections after SCI and
  • the person's diet or activities after SCI

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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 individual's GI microbiota and/or 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 (e.g. 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 person's 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.

Studietyp

Observationell

Inskrivning (Faktisk)

43

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • Manhasset, New York, Förenta staterna, 11030
        • The Feinstein Institute for Medical Research
  • Kalkon
    • Çankaya
      • Ankara, Çankaya, Kalkon, 06100
        • Gaziler PMR, Training and Research Hospital, Department of PMR
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada
        • University of Calgary Department of Clinical Neurosciences
    • New Brunswick
      • Fredericton, New Brunswick, Kanada
        • Stan Cassidy Center for Rehabilitation
  • Schweiz
      • Zürich, Schweiz
        • Balgrist University Hospital
  • Spanien
      • Barcelona, Spanien
        • Spinal Cord Injury Unit, Institut Guttmann Barcelona

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Participants will be recruited from both the acute and chronic populations of people living with SCI, specifically those treated as either inpatients and/or outpatients.

Beskrivning

INCLUSION CRITERIA ------------------------------------

  • Participants with acute SCI

    • Male or Female of the age of majority in his or her province/state/country OR Minor between 16 y.o. and the age of majority with informed consent provided by participant and parent or guardian.
    • Tetraplegic or paraplegic motor complete SCI (AIS A, B) or motor incomplete SCI (AIS C, D) involving a single non-penetrating traumatic injury to the C2-S1 spinal cord, treated surgically or non-surgically.
    • Preferably participants will be admitted to a study center within 48 hours of SCI. However, participants can be included within 7 days post injury.
    • Able to provide informed consent.
    • Able to converse in the language native to the country where the hospital is located.
    • Have the capacity to follow the study procedure.

  • Participants with chronic SCI

    • Male or Female of the age of majority in his or her province/state/country OR Minor between 16 y.o. and the age of majority with informed consent provided by participant and parent or guardian
    • Tetraplegic or paraplegic motor complete SCI (AIS A, B) or motor incomplete SCI (AIS C, D) involving a single non-penetrating traumatic injury to the C2-S1 spinal cord, treated surgically or non-surgically
    • Able to provide informed consent
    • Able to converse in the language native to the country where the hospital is located
    • Have the capacity to follow the study procedure

EXCLUSION CRITERIA ------------------------------------

  • Participants with acute SCI

    • Spinal cord injury with sensory deficit only (i.e. no motor deficit)
    • Penetrating spinal cord injury (including gunshot wounds)
    • Associated head injury or other major cognitive deficit (i.e. condition where comprehension may be impaired such that informed consent process or outcome assessment cannot be completed with confidence)
    • Concomitant medical conditions associated with SCI that would interfere with informed consent process or outcome assessment
    • Pre-existing history of a chronic bowel disorder (e.g. Crohn's disease, ulcerative colitis)

    • Pre-existing history of:

      • recurrent infectious diseases (3 or more times a year), e.g. urinary tract infections, pneumonia
      • Immune disorders (e.g. rheumatoid arthritis, systemic lupus) or
      • neurodegenerative syndromes
    • Presence of a systemic disease that might interfere with the safety, compliance or assessments being used in this project (e.g., clinically significant cardiac disease, including chronic hypertension, HIV)
    • Any other medical condition that in the investigator's opinion would render the protocol procedures dangerous or impair the ability of the patient to participate in the study
    • Female participants who are pregnant

  • Participants with chronic SCI

    • Spinal cord injury with sensory deficit only (i.e. no motor deficit)
    • Penetrating spinal cord injury (including gunshot wounds)
    • Associated head injury or other major cognitive deficit (i.e. condition where comprehension may be impaired such that informed consent process or outcome assessment cannot be completed with confidence)
    • Concomitant medical conditions associated with SCI that would interfere with informed consent process or outcome assessment
    • Pre-existing history of a chronic bowel disorder (e.g. Crohn's disease, ulcerative colitis)
    • Presence of a systemic disease that might interfere with the safety, compliance or assessments being used in this project (e.g., clinically significant cardiac disease, including chronic hypertension, HIV)
    • Any other medical condition that in the investigator's opinion would render the protocol procedures dangerous or impair the ability of the patient to participate in the study
    • Female participants who are pregnant

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Acute to first year after SCI
Individuals sustained SCI within a 1-year period
Chronic
Individuals sustained SCI more than1 year ago

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in GI microbiota
Tidsram: one year
Establishing the correlations between changes in neurological and functional capabilities in individuals with SCI and difference in the gut intestinal (GI) microbiota or metabolome and determining how such changes contribute to increased rates of infections
one year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of British Columbia

Samarbetspartners

Praxis Spinal Cord Institute

Utredare

  • Huvudutredare: John Steeves, PhD, University of British Columbia
  • Huvudutredare: Matthias Walter, MD, PhD, University of British Columbia
  • Huvudutredare: Brett Finlay, PhD, University of British Columbia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2017

Primärt slutförande (Faktisk)

31 december 2020

Avslutad studie (Faktisk)

31 december 2020

Studieregistreringsdatum

Först inskickad

13 september 2016

Först inskickad som uppfyllde QC-kriterierna

13 september 2016

Första postat (Uppskatta)

16 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 februari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 februari 2021

Senast verifierad

1 februari 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • H16-00954

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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