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

Starting soon · Not applicable

Conditions studied: Irritable Bowel Syndrome (IBS)

In brief

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.

Key facts

Study ID

NCT07475299

Run by

Iuliu Hatieganu University of Medicine and Pharmacy

People needed

8

Starts

2026-04-01

Expected to finish

2027-01-01

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Willingness to participate for the full duration of the study (approximately 16 weeks) and attend study visits (T0, T1, and Tfinal)
• Willingness to provide biological samples (blood and stool samples for microbiota analysis) according to the study protocol

You may not qualify if…

• 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
• Use of probiotic, prebiotic, or microbiota-modifying supplements within 4 weeks prior to baseline that cannot be discontinued
• Planned major dietary changes or initiation of new treatments for gastrointestinal symptoms during the study period
• Pregnancy or breastfeeding
• Known allergy or hypersensitivity to any component of the investigational supplement
• Any severe comorbid condition or circumstance that, in the opinion of the investigator, could increase risk to the participant or interfere with study results

Where it is running

• Department of Pharmaceutical Botany, Univeristy of Medicine and Pharmacy "Iuliu Hațieganu", 23 Gheorghe Marinescu Street, 3rd Floor, Cluj-Napoca, Romania — Cluj-Napoca, Romania

Full record on ClinicalTrials.gov

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