Synbiotic Supplement With Botanical Extracts for Gut Microbiota Balance in Irritable Bowel Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIuliu Hatieganu University of Medicine and Pharmacy

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.

Treatment groups

8 Participants
are divided into 1 treatment group