Comprehensive Management Strategies for Gastroesophageal Reflux Disease: A Study of Multidimensional Interventions and Health Impacts
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：Wei-Yi Lei Gastroenterology attending physician
- 電話番号：13224 +88638561825
- メール：hlmweb@tzuchi.com.tw
研究場所
-
-
Taiwan
-
Hualien City、Taiwan、台湾、970
- 募集
- Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
-
コンタクト：
- Wei-Yi Lei Gastroenterology attending physician
- 電話番号：13224 +88638561825
- メール：hlmweb@tzuchi.com.tw
-
-
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:
- Aged 18-79 years, mentally alert, and willing to provide written informed consent.
- Individuals with chronic gastroesophageal reflux symptoms (acid regurgitation, chest pain, or heartburn) who are willing to undergo dietary intervention.
Exclusion Criteria:
- Individuals with esophageal stricture, current or prior diagnosis of esophageal tumors, or a history of esophageal, upper gastrointestinal, or pharyngeal surgery.
- Individuals with structural esophageal disorders (e.g., diverticulum, esophageal rings), infectious esophagitis, or eosinophilic esophagitis.
- Individuals with major esophageal motility disorders.
- Individuals taking medications that may affect esophageal motility (e.g., opioids, nitrates, calcium channel blockers).
- Individuals who have used antidepressants, selective serotonin reuptake inhibitors (SSRIs), or other psychiatric medications continuously within the past three months, or are currently taking them.
- Pregnant women, or individuals unable to comply with lifestyle and dietary interventions for other reasons.
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 |
|---|---|
|
アクティブコンパレータ：Dietary intervention guided by a nutritionist
A nutritionist will assess the participant's dietary habits and food intake to determine whether they may trigger gastroesophageal reflux, and will provide guidance on how to adjust the diet accordingly.
There will be two sessions, each lasting 20 minutes, conducted at the start of the study and after 4 weeks.
|
A nutritionist will assess the participant's dietary habits and food intake to determine whether they may trigger gastroesophageal reflux, and will provide guidance on how to adjust the diet accordingly.
There will be two sessions, each lasting 20 minutes, conducted at the start of the study and after 4 weeks.
|
|
偽コンパレータ：Written dietary education intervention
Participants will be provided with an educational leaflet based on the national healthy eating guidelines and will be instructed to adjust their diet according to its content.
|
Participants will be provided with an educational leaflet based on the national healthy eating guidelines and will be instructed to adjust their diet according to its content.
|
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 |
|---|---|---|
|
Gastroesophageal Reflux Disease Questionnaire（GERDQ）
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The minimum score of the questionnaire is 0 and the maximum score is 18. The higher the score, the worse the gastroesophageal reflux symptoms. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Disease symptom index(DSI)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The minimum score of the questionnaire is 0 and the maximum score is 16. The higher the score, the worse the gastroesophageal reflux symptoms. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Global Symptom Severity Questionnaire(GSS)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The minimum score of the questionnaire is 0 and the maximum score is 100. The higher the score, the worse the gastroesophageal reflux symptoms. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Reflux Symptom Index(RSI)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The minimum score of the questionnaire is 0 and the maximum score is 45. The higher the score, the worse the gastroesophageal reflux symptoms. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Esophageal Hypervigilance and Anxiety Scale(EHAS)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The lowest score of the questionnaire is 0 and the highest score is 60. The higher the score, the more severe the esophageal hypervigilance and anxiety. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Pittsburgh Sleep Quality Index(PSQI)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The lowest score of the questionnaire is 0 and the highest score is 21. The higher the score, the worse the sleep quality. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Taiwanese Depression Questionnaire(TDQ)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The lowest score of the questionnaire is 0 and the highest score is 54. The higher the score, the higher the depression index. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
The State-Trait Anxiety Inventory(STAI)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The lowest score of the questionnaire is 1 and the highest score is 80. The higher the score, the more obvious the anxiety trait. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Visceral sensitivity index(VSI)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The lowest score of the questionnaire is 0 and the highest score is 75. The higher the score, the higher the visceral sensitivity. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Functional dyspepsia(FD)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. If any one of items 1, 4, 7, or 10 on the questionnaire scores more than 1 point and the symptoms have persisted for more than 6 months, the participant is classified as having FD. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Irritable bowel syndrome questionnaire(IBS)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. If the abdominal pain frequency score is greater than 4, persists for more than 6 months, and is associated with defecation, the participant is classified as having IBS. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Gastrointestinal Symptom Rating Scale(GSRS)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The questionnaire score ranges from 1 to 60, with higher scores indicating more severe gastrointestinal symptoms. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
GERD Health-related Quality of Life (GERD-HRQL)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The questionnaire score ranges from 0 to 77, with higher scores indicating poorer quality of life related to gastroesophageal reflux disease. |
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
|
Short-form-12-health-survey-questionnaire(SF-12)
時間枠：Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period. The results of the SF-12 health scale mainly include two total scores: physical health total score (PCS) and mental health total score (MCS). These two scores are used to measure an individual's health status in these two aspects.
|
Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
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。