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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecologic Barrier First-Month Sequence | Experimental | 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 Second-Month Sequence | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecologic Barrier | Dietary Supplement | Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points | 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 | Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks |
| Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score | 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 |
| Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR) | 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. | 2 weeks, 4 weeks, 8 weeks, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hang V Dao, PhD | Contact | +84 987988075 | hangdao.fsh@gmail.com | |
| Thuong T Nguyen, Bachelor | Contact | +84 983164220 | thuongnt.huph@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Gastroenterology and Hepatology | Recruiting | Hanoi | Hanoi | 10000 | Vietnam |
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| Ecologic Barrier | Dietary Supplement | Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment. |
|
| Baseline (0 weeks), 4 weeks and 8 weeks |
| Change from baseline in gastrointestinal symptom severity score | 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 |
| Incidence rate of specific treatment-emergent adverse events (TEAEs) | 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 | 2 weeks, 4 weeks, 8 weeks and 12 weeks |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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