再発性嚢炎の二次予防のためのリファキシミン
2026年7月30日 更新者：University of North Carolina, Chapel Hill
多くの人は回腸嚢炎の初回発症後に再発性回腸嚢炎（潰瘍性大腸炎の結腸切除術後の回腸嚢肛門吻合部または J 嚢の炎症）を発症しますが、現在、再発性回腸嚢炎を予防する効果的な治療法はありません。
この研究の目的は、初回の回腸嚢炎の治療後の再発性回腸嚢炎を予防する抗生物質であるリファキシミンの可能性を評価することです。
この研究では、すべての患者に回腸嚢炎の初期エピソードの治療後、1年間毎日リファキシミンが投与されます。
この研究では、再発性回腸嚢炎の予防を目的として、人々がリファキシミンを1年間服用する意思があるかどうかを調査します。
さらに、この研究では、患者がリファキシミン療法の予期せぬ副作用を経験するかどうかを調べる予定です。
この研究を通じて得られた情報は、潰瘍性大腸炎で結腸切除術を受けた患者における再発性回腸嚢炎を予防する能力を向上させるのに役立つ可能性があります。
調査の概要
研究の種類
介入
入学 (推定)
16
段階
- フェーズ 4
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。
研究連絡先
- 名前：Mikki Sandridge
- 電話番号：(919) 843-3873
- メール：mikki_sandridge@med.unc.edu
研究場所
-
-
New York
-
New York、New York、アメリカ、10016
- 募集
- NYU IBD Center
-
コンタクト：
- Nathasha Melukkaran
- 電話番号：646-754-3417
- メール：Nathasha.melukkaran@nyulangone.org
-
主任研究者：
- Shannon Chang, MD, MBA
-
-
North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- 募集
- University of North Carolina
-
コンタクト：
- Mikki Sandridge
- 電話番号：919-843-3873
- メール：mikki_sandridge@med.unc.edu
-
主任研究者：
- Edward Barnes, MD, MPH
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 研究関連の手続きの前にインフォームドコンセントが得られます
- 年齢 18 歳以上 75 歳未満
- 潰瘍性大腸炎の既往歴があり、1期、2期、修正-2期または3期の回腸嚢肛門吻合術（IPAA）および回腸瘻切除術の既往歴のある参加者
- 回腸瘻の解除後/IPAA手術の最終段階後、最初の12か月以内に回腸嚢炎の初期エピソードが診断された場合
除外基準:
- リファキシミンまたはその代謝物に対する既知の過敏症
- 既知のクローン病
- 肛門周囲瘻の病歴
- 肛門括約筋の機能不全による既知の失禁
- 既知の過敏性パウチ症候群
- ベースライン来院時に進行中の活動性骨盤感染症/敗血症
- IPAA後の最初の4週間に急性回腸炎の状況で新たに頻便が発症した
- 既知のクロストリドイデス・ディフィシル感染症
- 抗生物質による長期治療の必要性（例： ニキビにはドキシサイクリン）
- 既知の活動性B型肝炎、C型肝炎、HIV
- 臨床的に重大な肝疾患（LFTの正常上限値が1.5未満である原発性硬化性胆管炎が含まれる場合があります）
- 重度の肝障害、Child-Pugh クラス C として定義
- p-糖タンパク質（P-gp）阻害剤の併用（例、 シクロスポリン）
- 糸球体濾過速度が60 ml/分/1.732未満の既知の腎機能低下
- 回腸瘻の解除前16週間以内に糞便微生物叢の移植を受けている
- -基底細胞癌、皮膚の非転移性扁平上皮癌を除く悪性腫瘍の病歴、またはスクリーニングの少なくとも5年前に治癒療法が完了し再発がない以前の悪性腫瘍。
- 治験責任医師が局所検査から判断した、スクリーニング時またはベースライン時の臨床的に重要な臨床検査結果。
- 妊娠中、授乳中、または妊娠を計画している、または出産の可能性があり、非常に効果的な避妊法を使用していない女性。 妊娠の可能性のある女性は、薬を投与する前に尿妊娠検査で陰性でなければなりません。
- スクリーニング前30日以内の承認済みまたは未承認の治験薬の臨床試験への参加。
- 治験責任医師の意見では、参加者の安全またはプロトコールの順守を危険にさらす可能性がある障害。
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
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：参加者全員
550 mg リファキシミン (キシファキサン) 1 日 2 回 x 365 日
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リファキシミン 550 MG 経口錠剤 [XIFAXAN] 1 日 2 回、最長 365 日間服用
他の名前：
|
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 |
|---|---|---|
|
再発性嚢炎を発症した参加者の割合
時間枠：12ヶ月
|
再発性回腸嚢炎。回腸嚢炎の初回エピソードから 12 か月以内の 2 回目の回腸回炎、または最初の 14 日間の期間（およびリファキシミンの開始）後の長期/再発の抗生物質の必要性として定義されます。
|
12ヶ月
|
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。
協力者
捜査官
- 主任研究者：Edward Barnes, MD, MPH、University of North Carolina
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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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)
2024年7月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年7月1日
試験登録日
最初に提出
2024年3月8日
QC基準を満たした最初の提出物
2024年3月8日
最初の投稿 (実際)
2024年3月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月30日
最終確認日
2026年7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
- 23-2111
- R03DK140415 (米国 NIH グラント/契約)
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?
はい
IPD プランの説明
結果を裏付ける匿名化された個人データは、データの使用を提案する研究者が治験審査委員会 (IRB)、独立倫理委員会 (IEC)、または研究倫理委員会 (REB) の承認を得ている場合に限り、公表後 9 ～ 12 か月後に共有されます。 ) に応じて、UNC とデータ使用/共有契約を締結します。
IPD 共有時間枠
発行後 9 か月から 12 か月間継続
IPD 共有アクセス基準
治験責任医師は IRB、IEC、または REB を承認し、UNC とデータ使用/共有契約を締結しています。
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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。