Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pylori Duo as an Adjunctive Treatment and for the Prevention of Recurrence of Helicobacter Pylori Infection
調査の概要
状態
詳細な説明
This is a randomized, double-blind, placebo-controlled, single-center interventional clinical trial designed to evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 patients aged 18 to 70 years with a positive 13C-urea breath test and gastric biopsy performed before study initiation will be enrolled.
Participants will be randomly assigned to one of two parallel treatment groups. Group A will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days, followed by placebo for 3 months. Group B will receive the same standard quadruple therapy in combination with Pylori Duo for 10 days, followed by Pylori Duo for 3 months. Both investigators and participants will remain blinded to treatment allocation throughout the study.
The primary objective of the study is to evaluate the effect of Pylori Duo on the management of gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include evaluation of H. pylori eradication rate, recurrence of infection at 3 and 12 months after treatment, gastrointestinal symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS), gastrointestinal quality of life assessed using the Nepean Dyspepsia Index-Short Form (NDI-SF), and safety and tolerability. Safety assessments will include the recording of adverse events, evaluation of their potential relationship to the study product, and treatment adherence monitoring.
Participants will attend scheduled follow-up visits during treatment and post-treatment follow-up. A 13C-urea breath test will be performed 6 to 8 weeks after completion of Phase I treatment to assess eradication. Follow-up will continue for 3 months after treatment completion, and a telephone assessment will be conducted at 12 months to evaluate recurrence. Statistical analyses will be performed using both intention-to-treat and per-protocol populations.
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：Juan Antonio Carrillo, Medicine
- 電話番号：+34 647725527
- メール：carrillo@unex.es
研究場所
-
-
Badajoz
-
Don Benito、Badajoz、スペイン、06400
- GALA Laboratories
-
-
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 18 to 70 years.
- Confirmed Helicobacter pylori infection prior to treatment, as determined by a positive 13C-urea breath test (13C-UBT) and gastric biopsy.
- No previous H. pylori eradication therapy.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Significant underlying conditions that, in the opinion of the treating physician, would preclude participation in the study, including hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase >3 times the upper limit of normal), renal insufficiency (creatinine ≥2.0 mg/dL or glomerular filtration rate <50 mL/min), immunosuppression, malignant tumors, coronary heart disease or coronary artery stenosis ≥75%, thyroid disease, pulmonary disease, or any other serious medical condition.
- Pregnancy, breastfeeding, or unwillingness to use contraception during the study.
- Active gastrointestinal bleeding.
- History of upper gastrointestinal tract surgery.
- History of allergic reactions to medications included in the treatment regimen.
- Use of bismuth-containing agents, antibiotics, proton pump inhibitors, or other relevant medications within 4 weeks prior to treatment.
- Behaviors that may increase the risk of illness, including excessive alcohol consumption or substance abuse.
- Negative repeat urea breath test prior to treatment initiation.
- Unwillingness or inability to provide informed consent.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Standard Quadruple Therapy + Placebo
Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days during Phase I, followed by placebo for 3 months during Phase II.
|
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Pylera® will be administered in combination with omeprazole as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Placebo capsules identical in appearance to Pylori Duo, but without pharmacologically active ingredients, will be administered in combination with standard quadruple therapy for 10 days, followed by placebo for 3 months during the post-treatment phase.
|
|
実験的：Standard Quadruple Therapy + Pylori Duo
Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with Pylori Duo for 10 days during Phase I, followed by Pylori Duo for 3 months during Phase II.
|
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Pylera® will be administered in combination with omeprazole as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Pylori Duo is a dietary supplement containing Lactobacillus rhamnosus and dried licorice extract.
Participants assigned to the experimental arm will receive Pylori Duo in combination with standard quadruple therapy for 10 days, followed by Pylori Duo for 3 months during the post-treatment phase.
|
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 |
|---|---|---|
|
Gastrointestinal adverse effects associated with standard eradication therapy
時間枠：Up to 3 months after treatment initiation
|
Assessment of the effect of Pylori Duo on the management of gastrointestinal adverse effects associated with standard Helicobacter pylori eradication therapy.
Gastrointestinal tolerability will be evaluated during the treatment period and follow-up.
|
Up to 3 months after treatment initiation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Helicobacter pylori eradication rate
時間枠：6 to 8 weeks after completion of the 10-day treatment phase
|
Eradication of H. pylori will be assessed by negative 13C-urea breath test performed 6 to 8 weeks after completion of Phase I treatment.
Gastric biopsy may also be considered according to protocol-defined diagnostic assessment.
|
6 to 8 weeks after completion of the 10-day treatment phase
|
|
Recurrence of Helicobacter pylori infection
時間枠：3 months and 12 months after completion of treatment
|
Recurrence of H. pylori infection will be evaluated during follow-up at 3 and 12 months after treatment based on post-treatment clinical assessment and protocol-defined follow-up procedures.
|
3 months and 12 months after completion of treatment
|
|
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
時間枠：Baseline and 3 months after treatment initiation
|
Gastrointestinal symptoms will be assessed using the 15-item Gastrointestinal Symptom Rating Scale.
Each item is scored from 1, indicating no troublesome symptoms, to 7, indicating very troublesome symptoms.
The overall score is calculated as the mean of the 15 item scores and ranges from 1 to 7. Higher scores indicate greater gastrointestinal symptom severity and therefore a worse outcome.
Change from baseline will be evaluated during the follow-up period.
|
Baseline and 3 months after treatment initiation
|
|
Change from baseline in Short Form Nepean Dyspepsia Index total score
時間枠：Baseline and 3 months after treatment initiation
|
Gastrointestinal health-related quality of life will be assessed using the 10-item Short Form Nepean Dyspepsia Index.
The total score ranges from 0 to 100.
Higher scores indicate better gastrointestinal health-related quality of life and therefore a better outcome.
Change from baseline will be evaluated during the follow-up period.
|
Baseline and 3 months after treatment initiation
|
|
Participants with adverse events
時間枠：Up to 3 months after the first dose
|
Number and percentage of participants who experience at least one adverse event during the assessment period.
|
Up to 3 months after the first dose
|
|
Participants with study product-related adverse events
時間枠：Up to 3 months after the first dose
|
Number and percentage of participants who experience at least one adverse event considered by the investigator to be related to the study product.
|
Up to 3 months after the first dose
|
|
Treatment adherence
時間枠：Up to 3 months after the first dose
|
Treatment adherence will be reported as the percentage of prescribed study product doses taken.
The percentage will be calculated as the number of doses taken divided by the number of doses prescribed, multiplied by 100.
Higher percentages indicate greater treatment adherence.
|
Up to 3 months after the first dose
|
協力者と研究者
捜査官
- 主任研究者：Sergio Chamorro Benítez, Medicine、Hospital Parque Vegas Altas, Don Benito (Badajoz)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 20260836
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?
IPD プランの説明
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。