Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07475299
NA

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

Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

View on ClinicalTrials.gov

Summary

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.

Official title: The Impact of a Synbiotic Supplement Containing Botanical Extracts and Multiple Probiotic Strains on Gut Microbiota Balance in Patients With Irritable Bowel Syndrome: A Pilot Prospective Interventional Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-04

Completion Date

2027-01

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Synbiotic supplement containing probiotic strains, botanical extracts, magnesium, vitamin B1, and L-theanine designed to support gut microbiota balance.

Terranova 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.

Locations (1)

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

Cluj-Napoca, Romania