Effect of Omeprazole on Gut Microbiota in Adults With Obesity and GERD
Effect of Proton Pump Inhibitors on Gut Microbiota Composition in Adults With Obesity and Gastroesophageal Reflux Disease
This randomized, open-label, parallel-group study will evaluate the effect of short-term omeprazole therapy on gut and oral microbiota in adults aged 50-65 years with obesity and symptomatic gastroesophageal reflux disease. Participants will be randomized 1:1 to receive omeprazole 20 mg once daily for 14 days plus standard non-pharmacological recommendations for gastroesophageal reflux disease, or standard non-pharmacological recommendations alone. Clinical and laboratory assessments will be performed at baseline and after 14 days. Stool and saliva samples will be collected to assess gut and oral microbiota, and blood samples will be collected for laboratory biomarkers.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Georgy E. Leonov, MD, PhD
- 電話番号：+7 9055687783
- メール：golerus@gmail.com
研究場所
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-
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Moscow、ロシア、115446
- Federal Research Centre of Nutrition, Biotechnology and Food Safety
-
コンタクト：
- Georgy Leonov, MD, PhD
- 電話番号：+7 9055687783
- メール：golerus@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 50 to 65 years, inclusive.
- Obesity, defined as body mass index (BMI) ≥30 kg/m².
- Symptomatic gastroesophageal reflux disease with mild or moderate typical symptoms, including heartburn and/or regurgitation.
- For female participants, postmenopausal status, defined as absence of menstruation for at least 12 months without another apparent cause of amenorrhea.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Severe or exacerbated GERD, or GERD requiring acid-suppressive therapy or additional diagnostic evaluation.
- Use of proton pump inhibitors or histamine H2-receptor antagonists within 8 weeks prior to enrollment.
- Use of systemic antibiotics within 3 months prior to enrollment.
- Use of probiotic or synbiotic supplements within 8 weeks prior to enrollment.
- Inflammatory bowel disease, celiac disease, or other severe chronic gastrointestinal disorders that may substantially affect the gut microbiota.
- History of bariatric surgery or other major gastrointestinal surgery.
- Acute infectious or inflammatory disease at enrollment.
- History of myocardial infarction or stroke.
- Type 2 diabetes mellitus.
- Chronic heart failure, New York Heart Association functional class III-IV.
- Chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73 m².
- Alcohol dependence or other substance use disorder.
- Severe psychiatric disorder or cognitive impairment that may interfere with providing informed consent or adherence to the study protocol.
- Known hypersensitivity or contraindications to omeprazole.
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：基礎科学
- 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：Omeprazole Plus Standard Non-pharmacological Recommendations
Participants will receive omeprazole 20 mg orally once daily for 14 days in addition to standard non-pharmacological recommendations for gastroesophageal reflux disease. |
Omeprazole 20 mg administered orally once daily for 14 days. Standard non-pharmacological recommendations for gastroesophageal reflux disease management. |
|
アクティブコンパレータ：Standard Non-pharmacological Recommendations
Participants will receive standard non-pharmacological recommendations for gastroesophageal reflux disease for 14 days. |
Standard non-pharmacological recommendations for gastroesophageal reflux disease management. |
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 |
|---|---|---|
|
Change in gut microbiota beta diversity
時間枠：Baseline and Day 14
|
Gut microbiota beta diversity will be assessed using distance-based measures derived from 16S rRNA gene sequencing of stool samples, including Bray-Curtis dissimilarity and phylogenetic UniFrac distances. |
Baseline and Day 14
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Shannon diversity index
時間枠：Baseline and Day 14
|
Change in gut microbiota alpha diversity assessed using the Shannon diversity index derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater microbial diversity. |
Baseline and Day 14
|
|
Change in Simpson diversity index
時間枠：Baseline and Day 14
|
Change in gut microbiota alpha diversity assessed using the Simpson diversity index derived from 16S rRNA gene sequencing of stool samples. Values range from 0 to 1, with higher values indicating greater microbial diversity. |
Baseline and Day 14
|
|
Change in Chao1 richness estimator
時間枠：Baseline and Day 14
|
Change in gut microbiota richness assessed using the Chao1 richness estimator derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater estimated microbial richness. |
Baseline and Day 14
|
|
Change in modified Frequency Scale for the Symptoms of GERD total score
時間枠：Baseline and Day 14
|
Change in the total modified Frequency Scale for the Symptoms of GERD (mFSSG) score from baseline to Day 14. The questionnaire includes 14 items scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more frequent GERD-related symptoms. |
Baseline and Day 14
|
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Change in high-sensitivity C-reactive protein concentration
時間枠：Baseline and Day 14
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Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration. |
Baseline and Day 14
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Change in systemic immune-inflammation index
時間枠：Baseline and Day 14
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Change in the systemic immune-inflammation index (SII), calculated as platelet count × neutrophil count / lymphocyte count. |
Baseline and Day 14
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in oral microbiota composition
時間枠：Baseline and Day 14
|
Changes in oral microbiota composition will be assessed using microbiome analysis of saliva samples, including measures of microbial diversity and taxonomic composition. |
Baseline and Day 14
|
|
Change in serum lipopolysaccharide-binding protein concentration
時間枠：Baseline and Day 14
|
Change in serum lipopolysaccharide-binding protein (LBP) concentration from baseline to Day 14. |
Baseline and Day 14
|
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
追加の関連 MeSH 用語
その他の研究ID番号
- PPI-MICROBIOME-7-02-09-2026
- 22-15-00252-P (その他の助成金/資金番号：Russian Science Foundation)
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
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