Irritable Bowel Syndrome With DiarrheaNCT07656623
Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
A study testing Ecologic Barrier in people with Irritable Bowel Syndrome With Diarrhea, run by Institute of Gastroenterology and Hepatology, Vietnam at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Ecologic Barrier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Institute of Gastroenterology and Hepatology
Hanoi, Hanoi, 10000
Hang V Dao, PhD, +84 987988075, hangdao.fsh@gmail.com
Thuong T Nguyen, Bachelor, +84 983164220, thuongnt.huph@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Ecologic Barrier
- Keywords
- Irritable bowel syndrome, IBS-D, Probiotics, DASS-21, Upper gastrointestinal symptoms, Stress, Depression, Anxiety
- Medical subject headings
- Irritable Bowel Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologic BarrierDietary supplement
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Ecologic BarrierDietary supplement
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ecologic Barrier |
| 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. Receives: Dietary Supplement: Ecologic Barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 2 weeks, 4 weeks, 8 weeks, and 12 weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 2 weeks, 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Gastroenterology and Hepatology, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656623
- Sponsor's protocol ID
- EB2406
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07656623
- Acronym / sponsor ID
- EB2406
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- Irritable bowel syndrome, IBS-D, Probiotics, DASS-21, Upper gastrointestinal symptoms, Stress, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Gastroenterology and Hepatology, VietnamUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ecologic Barrier First-Month Sequence | Experimental | Dietary Supplement: Ecologic BarrierThis 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 Second-Month Sequence | Experimental | Dietary Supplement: Ecologic BarrierThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecologic BarrierEcologic Barrier will be added to the standard treatment regimen during the first month of treatment. | Dietary supplement | Ecologic Barrier First-Month Sequence |
| Ecologic BarrierEcologic Barrier will be added to the standard treatment regimen during the second month of treatment. | Dietary supplement | Ecologic Barrier Second-Month Sequence |
Primary outcome
Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points
Time frame: 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
Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score
Time frame: 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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
Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR)
Time frame: 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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.
3 secondary outcomes
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores
Time frame: Baseline (0 weeks), 4 weeks and 8 weeks
Change from baseline in gastrointestinal symptom severity score
Time frame: Baseline (0 weeks), 4 weeks, and 8 weeks
Incidence rate of specific treatment-emergent adverse events (TEAEs)
Time frame: 2 weeks, 4 weeks, 8 weeks and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome With Diarrhea
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Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
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A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
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Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecologic Barrier in people with Irritable Bowel Syndrome With Diarrhea, run by Institute of Gastroenterology and Hepatology, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hang V Dao, PhD (+84 987988075, hangdao.fsh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points (time frame: Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.