Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
2026年6月15日 更新者：Institute of Gastroenterology and Hepatology, Vietnam
The Effects of the Multispecies Probiotic Mixture Ecologic Barrier for Patients With Irritable Bowel Syndrome With Upper Gastrointestinal Symptoms and Having Anxiety, Depression, and Stress Symptoms
The aim of this clinical trial is to find out whether Ecologic Barrier is effective in supporting the treatment of irritable bowel syndrome (IBS) in adults. The main questions that this trial aims to answer are:
- Does Ecologic Barrier help improve IBS severity when added to standard IBS treatment?
- Does Ecologic Barrier help improve symptoms of anxiety, depression, and stress in patients with IBS?
- Does Ecologic Barrier help improve upper gastrointestinal symptoms when added to standard IBS treatment?
- What adverse events may occur when using Ecologic Barrier? The researchers will compare a group receiving standard symptom-based treatment with another group receiving standard treatment plus Ecologic Barrier.
Participants will:
- Receive IBS treatment for 2 months, with Ecologic Barrier added during either the first month or the second month, depending on random assignment.
- Attend a follow-up visit after 1 month of treatment.
- Take part in interviews about IBS severity, symptom improvement, adverse events, and symptoms of depression and anxiety at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
調査の概要
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
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：Hang V Dao, PhD
- 電話番号：+84 987988075
- メール：hangdao.fsh@gmail.com
研究連絡先のバックアップ
- 名前：Thuong T Nguyen, Bachelor
- 電話番号：+84 983164220
- メール：thuongnt.huph@gmail.com
研究場所
-
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Hanoi
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Hanoi、Hanoi、ベトナム、10000
- 募集
- Institute of Gastroenterology and Hepatology
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コンタクト：
- Hang V Dao, PhD
- 電話番号：+84 987988075
- メール：hangdao.fsh@gmail.com
-
コンタクト：
- Thuong T Nguyen, Bachelor
- 電話番号：+84 983164220
- メール：thuongnt.huph@gmail.com
-
主任研究者：
- Hang V Dao, PhD
-
-
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
Inclusion Criteria:
- Indication for upper endoscopy and colonoscopy;
- Diagnosed with IBS-D according to Rome IV criteria;
- Presence of at least one upper gastrointestinal symptom, including: retrosternal burning, reflux, epigastric pain, epigastric burning, postprandial discomfort, early satiety, abdominal bloating, belching, sour regurgitation, nausea/vomiting;
- Manifestations of anxiety, depression, or stress, with at least one of the three DASS-21 subscale scores exceeding the normal threshold (depression score >9 and/or anxiety score >7 and/or stress score >14).
Exclusion Criteria:
- Positive for Helicobacter pylori by rapid urease test during endoscopy or by 13C-urea breath test;
- Currently using anxiolytic or antidepressant medication;
- Currently or previously used antibiotics within the past month;
- Currently or previously used symptomatic treatment, probiotics, or proton pump inhibitors (PPI) within the past two weeks;
- History of gastrointestinal surgery;
- Endoscopic findings of organic lesions: ulcer, acute inflammation, colonic polyp >5 mm, or colonic polyp <5 mm with suspected neoplasia;
- Pregnant or breastfeeding women.
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：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Ecologic Barrier First-Month Sequence
This group included IBS-D patients who were prescribed a standard 2-month treatment regimen and received the study product as an add-on therapy during the first month.
|
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
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実験的：Ecologic Barrier Second-Month Sequence
This group included IBS-D patients who were prescribed a standard 2-month treatment regimen and received the study product as an add-on therapy during the second month.
|
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
|
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 from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points
時間枠：Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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The IBS-SSS score assesses the severity of IBS symptoms based on abdominal pain intensity, abdominal pain frequency, abdominal distension, dissatisfaction with bowel habits, and interference with daily life
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Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score
時間枠：2 weeks, 4 weeks, 8 weeks, and 12 weeks
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The IBS-GAI is a self-administered questionnaire used to assess the overall change in IBS symptoms compared to the baseline.
Patients answer a question such as "Compared to the way you felt before beginning the trial, have your IBS symptoms changed?" on a 7-point Likert scale ranging from 1 (substantially worse) to 7 (substantially improved).
Higher scores indicate greater improvement
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2 weeks, 4 weeks, 8 weeks, and 12 weeks
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Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR)
時間枠：2 weeks, 4 weeks, 8 weeks, and 12 weeks
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The IBS-AR is a single, dichotomous question asked to assess if patients obtained adequate relief of their IBS symptoms.
Responses are categorical (Yes or No).
The outcome is reported as the percentage of participants responding "Yes" at each evaluated time point.
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2 weeks, 4 weeks, 8 weeks, and 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores
時間枠：Baseline (0 weeks), 4 weeks and 8 weeks
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The DASS-21 is a 21-item self-report questionnaire designed to measure three related negative emotional states: depression, anxiety, and stress (7 items per subscale).
Each item is scored from 0 (did not apply to me at all) to 3 (applied to me very much).
For each subscale (Depression, Anxiety, and Stress), the scores of its 7 items are summed and multiplied by 2. Each individual subscale yields a final score range of 0 to 42.
Higher scores in each subscale indicate greater severity of the respective symptoms.
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Baseline (0 weeks), 4 weeks and 8 weeks
|
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Change from baseline in gastrointestinal symptom severity score
時間枠：Baseline (0 weeks), 4 weeks, and 8 weeks
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Gastrointestinal symptom severity is assessed using a 10-point Visual Analog Scale (VAS).
The scale ranges from 0 to 10, where a score of 0 represents "normal" (no symptoms), 1-3 represents "mild", 4-6 represents "moderate", and 7-10 represents "severe" symptoms.
The final outcome is reported as the change in the total severity score from baseline to each subsequent follow-up period.
Higher scores indicate greater severity of gastrointestinal symptoms
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Baseline (0 weeks), 4 weeks, and 8 weeks
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Incidence rate of specific treatment-emergent adverse events (TEAEs)
時間枠：2 weeks, 4 weeks, 8 weeks and 12 weeks
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The incidence rate of specific treatment-emergent adverse events (TEAEs) is actively assessed at each follow-up.
The pre-specified checklist of symptoms includes: abdominal bloating, abdominal distension, bowel habit disorders, headache, dizziness, nausea, heartburn/retrosternal burning, sleep disorders, and other unlisted events.
For each reported symptom, the onset time and duration will be documented
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2 weeks, 4 weeks, 8 weeks and 12 weeks
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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。
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6月1日
一次修了 (推定)
2026年6月30日
研究の完了 (推定)
2026年6月30日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1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。