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.
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
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
Single group
Synbiotic supplement containing probiotic strains, botanical extracts, magnesium, vitamin B1, and L-theanine designed to support gut microbiota balance.
Dietary supplementTerranova Microbiome Challenge is a synbiotic dietary supplement containing a Magnifood botanical complex (250 mg) composed of organic fresh freeze-dried artichoke leaf (Cynara scolymus) 50 mg, ginger root/rhizome (Zingiber officinale) 50 mg, bilberry (Vaccinium myrtillus) 50 mg, German chamomile flower (Matricaria recutita/Chamomilla) 50 mg, and lemon balm leaf (Melissa officinalis L.) 50 mg. The microflora blend (92 mg) includes Bacillus coagulans (BC10) 2 billion CFU, Bifidobacterium bifidum (novaBBF7) 1 billion CFU, Lactocaseibacillus rhamnosus (G1) 1 billion CFU, and Lactiplantibacillus plantarum (T7) 1 billion CFU. The formulation also contains magnesium (as bisglycinate chelate (TRAACS™) oxide) 50 mg, vitamin B1 (as thiamine mononitrate) 50 mg, and L-theanine extracted from green tea leaf (Camellia sinensis) 25 mg. The supplement is delivered in a vegetarian capsule shell made of hydroxypropyl methylcellulose.
Change in gastrointestinal symptom severity associated with Irritable Bowel Syndrome assessed by IBS Symptom Severity Score (IBS-SSS)
The change in gastrointestinal symptom severity will be assessed using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS), a validated questionnaire that evaluates abdominal pain severity, abdominal pain frequency, bloating severity, satisfaction with bowel habits, and interference with daily life. Each domain is scored on a scale from 0 to 100, with a total score ranging from 0 to 500, where higher scores indicate more severe symptoms. Change in the IBS-SSS total score will be calculated between baseline (T0) and the end of treatment at week 16.
Change in gut microbiota alpha diversity measured by 16S rRNA gene sequencing
Gut microbiota composition will be assessed in stool samples using next-generation sequencing (NGS) of the 16S rRNA gene. Alpha diversity will be evaluated using the Shannon diversity index, which reflects both the richness and evenness of microbial communities. Changes in the Shannon index will be assessed across study time points.
Change in serum AST levels
Serum aspartate aminotransferase levels will be measured in blood samples collected during the study to assess potential changes associated with the intervention.
Change in stool consistency assessed by Bristol Stool Form Scale
Stool consistency will be assessed using the Bristol Stool Form Scale. Changes in stool form will be evaluated between baseline and the end of treatment.
Change in serum alanine aminotransferase (ALT) levels
Serum alanine aminotransferase levels will be measured in blood samples collected during the study to monitor potential changes over time.
Change in serum gamma-glutamyl transferase (GGT) levels
Serum gamma-glutamyl transferase levels will be measured in blood samples collected during the study to monitor potential hepatic safety changes.
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