About this trial
The goal of this clinical trial is to evaluate whether a synbiotic dietary supplement containing botanical extracts and multiple probiotic strains can improve gastrointestinal symptoms and modulate gut microbiota composition in adults diagnosed with Irritable Bowel Syndrome (IBS).
The main questions it aims to answer are:
Does supplementation with the synbiotic product improve functional gastrointestinal symptoms associated with IBS (e.g., bloating, abdominal discomfort, and bowel habit disturbances)?
Does the intervention lead to measurable changes in gut microbiota composition and selected biological markers compared with baseline measurements?
Participants will:
undergo baseline evaluation including symptom assessment, blood tests, and stool sample collection for gut microbiota analysis;
complete an 8-week observation period without intervention to establish baseline variability;
take the synbiotic supplement once daily for 8 weeks;
repeat clinical assessments, blood tests, and gut microbiota analysis during follow-up visits.
Eligibility criteria
Qualifiers
Adults aged ≥18 years
Clinically confirmed diagnosis of Irritable Bowel Syndrome documented in the medical record
Presence of recurrent gastrointestinal symptoms such as bloating, abdominal discomfort, gas, or bowel habit disturbances (constipation, diarrhea, or mixed pattern) considered clinically relevant by the participant
Ability to understand the study procedures and provide written informed consent
Disqualifiers
Known or suspected organic gastrointestinal disease explaining the symptoms (e.g., inflammatory bowel disease, untreated celiac disease, gastrointestinal malignancy)
Presence of alarm symptoms such as unexplained gastrointestinal bleeding, significant unintentional weight loss, persistent fever, severe anemia, or signs of acute infection
Acute gastrointestinal infection at the time of screening
Use of antibiotics within the previous 4-8 weeks prior to baseline
Trial design
Treatments tested in this trial
- Synbiotic supplement containing probiotic strains, botanical extracts, magnesium, vitamin B1, and L-theanine designed to support gut microbiota balance.