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Gastrointestinal and Urinary Tract Microbiome After SCI

2021年2月2日 更新者：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

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

43

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • New York
      • Manhasset、New York、アメリカ、11030
        • The Feinstein Institute for Medical Research
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ
        • University of Calgary Department of Clinical Neurosciences
    • New Brunswick
      • Fredericton、New Brunswick、カナダ
        • Stan Cassidy Center for Rehabilitation
  • スイス
      • Zürich、スイス
        • Balgrist University Hospital
  • スペイン
      • Barcelona、スペイン
        • Spinal Cord Injury Unit, Institut Guttmann Barcelona
  • 七面鳥
    • Çankaya
      • Ankara、Çankaya、七面鳥、06100
        • Gaziler PMR, Training and Research Hospital, Department of PMR

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Acute to first year after SCI
Individuals sustained SCI within a 1-year period
Chronic
Individuals sustained SCI more than1 year ago

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Changes in GI microbiota
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of British Columbia

協力者

Praxis Spinal Cord Institute

捜査官

  • 主任研究者：John Steeves, PhD、University of British Columbia
  • 主任研究者：Matthias Walter, MD, PhD、University of British Columbia
  • 主任研究者：Brett Finlay, PhD、University of British Columbia

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年9月1日

一次修了 (実際)

2020年12月31日

研究の完了 (実際)

2020年12月31日

試験登録日

最初に提出

2016年9月13日

QC基準を満たした最初の提出物

2016年9月13日

最初の投稿 (見積もり)

2016年9月16日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月5日

QC基準を満たした最後の更新が送信されました

2021年2月2日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • H16-00954

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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