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.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Hang V Dao, PhD
- 电话号码：+84 987988075
- 邮箱：hangdao.fsh@gmail.com
研究联系人备份
- 姓名：Thuong T Nguyen, Bachelor
- 电话号码：+84 983164220
- 邮箱：thuongnt.huph@gmail.com
学习地点
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Hanoi
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Hanoi、Hanoi、越南、10000
- 招聘中
- Institute of Gastroenterology and Hepatology
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接触：
- Hang V Dao, PhD
- 电话号码：+84 987988075
- 邮箱：hangdao.fsh@gmail.com
-
接触：
- Thuong T Nguyen, Bachelor
- 电话号码：+84 983164220
- 邮箱：thuongnt.huph@gmail.com
-
首席研究员：
- Hang V Dao, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
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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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实验性的：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points
大体时间：Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks
|
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
大体时间：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
|
2 weeks, 4 weeks, 8 weeks, and 12 weeks
|
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Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores
大体时间：Baseline (0 weeks), 4 weeks and 8 weeks
|
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.
|
Baseline (0 weeks), 4 weeks and 8 weeks
|
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Change from baseline in gastrointestinal symptom severity score
大体时间：Baseline (0 weeks), 4 weeks, and 8 weeks
|
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
|
Baseline (0 weeks), 4 weeks, and 8 weeks
|
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Incidence rate of specific treatment-emergent adverse events (TEAEs)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年6月1日
初级完成 (估计的)
2026年6月30日
研究完成 (估计的)
2026年6月30日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年6月15日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.