Levofloxacin-Based Sequential Therapy Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
Levofloxacin-Based Sequential Therapy Compared With Bismuth-Based Quadruple Therapy for Eradication of Helicobacter Pylori Infection: A Randomized Controlled Trial
This randomized controlled trial aims to compare the efficacy and safety of levofloxacin-based sequential therapy versus bismuth-based quadruple therapy for eradication of Helicobacter pylori infection in adult patients. Helicobacter pylori infection remains highly prevalent in developing countries and is associated with gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Increasing antibiotic resistance has reduced the effectiveness of conventional treatment regimens, creating a need for alternative first-line therapies with improved eradication rates and acceptable tolerability.
Eligible adult patients diagnosed with H. pylori infection by stool antigen testing will be recruited from the Gastroenterology Department of Services Hospital Lahore. Participants will be randomly assigned in a 1:1 ratio to receive either levofloxacin-based sequential therapy or bismuth-based quadruple therapy for 14 days.
The primary outcome of the study is successful eradication of H. pylori infection, confirmed by stool antigen testing performed 6 weeks after completion of therapy. Secondary outcomes include treatment-related adverse effects, treatment compliance, and overall treatment cost.
The study aims to identify an effective and affordable treatment strategy for H. pylori eradication in a population with high antibiotic resistance and socioeconomic limitations.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tanveer Principal Investigator
- 電話番号：030708693386
- メール：tenu9428@gmail.com
参加基準
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
説明
Inclusion Criteria:
- Adults aged 20 years and older
- Confirmed Helicobacter pylori infection by stool antigen testing
- Willingness to comply with the assigned treatment regimen
- Ability to provide informed consent
- Willingness to complete follow-up evaluation
Exclusion Criteria:
- Use of antibiotics within 4 weeks prior to enrollment
- Active gastrointestinal infection other than Helicobacter pylori
- Previous gastrointestinal tract surgery
- Pregnant or lactating females
- Known allergy or intolerance to study medications
- Psychiatric illness or other condition impairing treatment compliance
- Severe comorbid illness making participation unsuitable in the investigator's judgment
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：Levofloxacin-Based Sequential Therapy
Participants assigned to this arm will receive levofloxacin-based sequential therapy for 14 days.
During days 1-7, participants will receive dexlansoprazole 60 mg twice daily and amoxicillin 1 g twice daily.
During days 8-14, participants will receive dexlansoprazole 60 mg twice daily, levofloxacin 500 mg once daily, and tinidazole 500 mg twice daily.
|
Participants will receive a 14-day levofloxacin-based sequential therapy regimen.
During days 1-7, participants will receive dexlansoprazole 60 mg twice daily and amoxicillin 1 g twice daily.
During days 8-14, participants will receive dexlansoprazole 60 mg twice daily, levofloxacin 500 mg once daily, and tinidazole 500 mg twice daily.
|
|
アクティブコンパレータ：Bismuth-Based Quadruple Therapy
Participants assigned to this arm will receive bismuth-based quadruple therapy for 14 days, consisting of bismuth subsalicylate 265 mg (two tablets) twice daily, dexlansoprazole 60 mg twice daily, doxycycline (Vibramycin) 100 mg twice daily, and tinidazole 500 mg twice daily.
|
Participants will receive a 14-day bismuth-based quadruple therapy regimen consisting of bismuth subsalicylate 265 mg (two tablets) twice daily, dexlansoprazole 60 mg twice daily, doxycycline 100 mg twice daily, and tinidazole 500 mg twice daily.
|
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 |
時間枠 |
|---|---|
|
Helicobacter pylori Eradication Rate
時間枠：6 weeks after completion of therapy
|
6 weeks after completion of therapy
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 156
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?
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
米国FDA規制機器製品の研究
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。