UMIN-CTR 臨床試験登録情報の閲覧

BACK TOP
UMIN-CTR ホーム 用語の説明(簡易版) 用語の説明(詳細版)--準備中 FAQ

利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000004085
受付番号 R000004922
科学的試験名 Synbiotic therapy for patients on long term mechanical ventilation support
一般公開日(本登録希望日) 2010/08/23
最終更新日 2010/08/22

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title Synbiotic therapy for patients on long term mechanical ventilation support Synbiotic therapy for patients on long term mechanical ventilation support
一般向け試験名略称/Acronym Synbiotic therapy for patients on long term mechanical ventilation support Synbiotic therapy for patients on long term mechanical ventilation support
科学的試験名/Scientific Title Synbiotic therapy for patients on long term mechanical ventilation support Synbiotic therapy for patients on long term mechanical ventilation support
科学的試験名略称/Scientific Title:Acronym Synbiotic therapy for patients on long term mechanical ventilation support Synbiotic therapy for patients on long term mechanical ventilation support
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition patients on long term mechanical ventilation support patients on long term mechanical ventilation support
疾患区分1/Classification by specialty
集中治療医学/Intensive care medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 The objective was to investigate the effect of the colonization of Pseudomonas aeruginosa, fecal organic acids, and gut flora by synbiotic therapy. The objective was to investigate the effect of the colonization of Pseudomonas aeruginosa, fecal organic acids, and gut flora by synbiotic therapy.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes amount of the colonization of Pseudomonas aeruginosa, changese of fecal organic acids and gut flora.
amount of the colonization of Pseudomonas aeruginosa, changese of fecal organic acids and gut flora.
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine 食品/Food
介入1/Interventions/Control_1 Patients in the synbiotic group were administrated Lactobacillus casei strain Shirota, Bifidobacterium breve strain Yakult, and galactooligosaccharides as synbiotics for 8 weeks. Patients in the synbiotic group were administrated Lactobacillus casei strain Shirota, Bifidobacterium breve strain Yakult, and galactooligosaccharides as synbiotics for 8 weeks.
介入2/Interventions/Control_2 Patients in control groups were not administered any of these synbiotics. Patients in control groups were not administered any of these synbiotics.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria The present study included patients who received mechanical ventilation support and administration of enteral tube feeding for more than one month The present study included patients who received mechanical ventilation support and administration of enteral tube feeding for more than one month
除外基準/Key exclusion criteria Patients were excluded if they were under 18 years of age or had a terminal illness. Patients who had received selective digestive decontamination, or prebiotic and probiotic therapies were also excluded. Patients were excluded if they were under 18 years of age or had a terminal illness. Patients who had received selective digestive decontamination, or prebiotic and probiotic therapies were also excluded.
目標参加者数/Target sample size 50

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム
Mineji Hayakawa

ミドルネーム
Mineji Hayakawa
所属組織/Organization Hokkaido University Hospital Hokkaido University Hospital
所属部署/Division name Emergency and Critical Care Center Emergency and Critical Care Center
郵便番号/Zip code
住所/Address N14W5 Kita-ku, Sapporo 060-8648 Japan N14W5 Kita-ku, Sapporo 060-8648 Japan
電話/TEL
Email/Email

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム

組織名/Organization Hokkaido University Hospital Hokkaido University Hospital
部署名/Division name Emergency and Critical Care Center Emergency and Critical Care Center
郵便番号/Zip code
住所/Address

電話/TEL
試験のホームページURL/Homepage URL
Email/Email mineji@dream.com

実施責任組織/Sponsor
機関名/Institute その他 Hokkaido University Hospital
機関名/Institute
(機関選択不可の場合)
北海道大学病院
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Hokkaido University Hospital
機関名/Organization
(機関選択不可の場合)
北海道大学病院
組織名/Division
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2010 08 23

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2008 07 09
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2008 12 01
フォロー終了(予定)日/Last follow-up date
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2010 08 22
最終更新日/Last modified on
2010 08 22


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000004922
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004922

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


UMIN臨床試験登録システムのご使用に関するお問い合わせは、こちらのお問い合わせフォーム からお願いいたします。それ以外のお問い合わせは、 こちら よりお願い致します。