Irritable Bowel Syndrome (IBS) Clinical Trials

Find Irritable Bowel Syndrome (IBS) Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Viet Nam
Institute of Gastroenterology and Hepatology
RECRUITING
Hanoi
Contact Information
Primary
Hang V Dao, PhD
hangdao.fsh@gmail.com
+84 987988075
Backup
Thuong T Nguyen, Bachelor
thuongnt.huph@gmail.com
+84 983164220
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Experimental: 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.
Sponsors
Leads: Institute of Gastroenterology and Hepatology, Vietnam

This content was sourced from clinicaltrials.gov