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

NCT07475299 | Not Yet Recruiting

• 1 other identifier: DEP75/06.03.2026
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

IBS; Synbiotic; Botanical Extracts; Probiotics; Gastrointestinal Symptoms; Digestive Health; Microbiota Diversity; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (1)

• Change in gut microbiota alpha diversity measured by 16S rRNA gene sequencing

  From enrollment to the end of treatment at 16 weeks

Other Outcomes (9)

• Change in serum AST levels

  From enrollment to the end of treatment at 16 weeks

• Change in stool consistency assessed by Bristol Stool Form Scale

  Baseline to week 16

• Change in serum alanine aminotransferase (ALT) levels

  Baseline to week 16

Study Arms (1)

IBS group

EXPERIMENTAL

Subjects diagnosed with IBS

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

Interventions

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

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.

Also known as: TERRANOVA Microbiome Challenge

IBS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

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

Cluj-Napoca, 400337, Romania

Location

Related Publications (12)

• Xu W, Kong Y, Zhang T, Gong Z, Xiao W. L-Theanine regulates lipid metabolism by modulating gut microbiota and bile acid metabolism. J Sci Food Agric. 2023 Feb;103(3):1283-1293. doi: 10.1002/jsfa.12222. Epub 2022 Sep 23.

  PMID: 36087337 BACKGROUND

• Del Chierico F, Trapani V, Petito V, Reddel S, Pietropaolo G, Graziani C, Masi L, Gasbarrini A, Putignani L, Scaldaferri F, Wolf FI. Dietary Magnesium Alleviates Experimental Murine Colitis through Modulation of Gut Microbiota. Nutrients. 2021 Nov 23;13(12):4188. doi: 10.3390/nu13124188.

  PMID: 34959740 BACKGROUND

• Brochot A, Azalbert V, Landrier JF, Tourniaire F, Serino M. A Two-Week Treatment with Plant Extracts Changes Gut Microbiota, Caecum Metabolome, and Markers of Lipid Metabolism in ob/ob Mice. Mol Nutr Food Res. 2019 Sep;63(17):e1900403. doi: 10.1002/mnfr.201900403. Epub 2019 Jun 25.

  PMID: 31206248 BACKGROUND

• Cao X, Yao F, Liu W, Wang Y, Zhang Z, Zhang C, Dong Z, Zhang B, He R, Sun X. Vaccinium myrtillus L. ameliorates diabetic nephropathy via modulating metabolites and gut microbiota in rats. Front Pharmacol. 2025 Apr 8;16:1541947. doi: 10.3389/fphar.2025.1541947. eCollection 2025.

  PMID: 40264677 BACKGROUND

• Kim J, Ha J, Kim S, Kim G, Shin H. Impact of Ginger on Gut Microbiota Composition and Function in a Bacteroides-Dominant Enterotype. J Microbiol Biotechnol. 2025 May 26;35:e2503032. doi: 10.4014/jmb.2503.03032.

  PMID: 40443219 BACKGROUND

• Khazaei R, Seidavi A, Bouyeh M, Ogbuagu NE, Gonzalez DNT, Elghandour MMMY, Salem AZM. Effects of varying levels of Cynara scolymus powder on growth performance, carcass characteristics, intestinal microbiota, immune and haemato-biochemical parameters in female quails. Res Vet Sci. 2024 Mar;169:105162. doi: 10.1016/j.rvsc.2024.105162. Epub 2024 Jan 24.

  PMID: 38301341 BACKGROUND

• Tinazzi M, Sacilotto A, Cocetta V, Giacomini I, Raso F, Bulferi G, De Togni H, Lanza R, Consolo P, Berretta M, Montopoli M. Bowel Inflammation and Nutrient Supplementation: Effects of a Fixed Combination of Probiotics, Vitamins, and Herbal Extracts in an In Vitro Model of Intestinal Epithelial Barrier Dysfunction. Yale J Biol Med. 2024 Sep 30;97(3):297-308. doi: 10.59249/JOMF5336. eCollection 2024 Sep.

  PMID: 39351327 BACKGROUND

• Cosier DJ, Lambert K, Neale EP, Probst Y, Charlton K. The effect of oral synbiotics on the gut microbiota and inflammatory biomarkers in healthy adults: a systematic review and meta-analysis. Nutr Rev. 2025 Feb 1;83(2):e4-e24. doi: 10.1093/nutrit/nuae002.

  PMID: 38341803 BACKGROUND

• Chandrasekaran P, Weiskirchen S, Weiskirchen R. Effects of Probiotics on Gut Microbiota: An Overview. Int J Mol Sci. 2024 May 30;25(11):6022. doi: 10.3390/ijms25116022.

  PMID: 38892208 BACKGROUND

• LeBlanc JG, Milani C, de Giori GS, Sesma F, van Sinderen D, Ventura M. Bacteria as vitamin suppliers to their host: a gut microbiota perspective. Curr Opin Biotechnol. 2013 Apr;24(2):160-8. doi: 10.1016/j.copbio.2012.08.005. Epub 2012 Aug 30.

  PMID: 22940212 BACKGROUND

• Buhas MC, Gavrilas LI, Candrea R, Catinean A, Mocan A, Miere D, Tataru A. Gut Microbiota in Psoriasis. Nutrients. 2022 Jul 20;14(14):2970. doi: 10.3390/nu14142970.

  PMID: 35889927 BACKGROUND

• Chen X, Pan S, Li F, Xu X, Xing H. Plant-Derived Bioactive Compounds and Potential Health Benefits: Involvement of the Gut Microbiota and Its Metabolic Activity. Biomolecules. 2022 Dec 13;12(12):1871. doi: 10.3390/biom12121871.

  PMID: 36551299 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Magnesium; Thiamine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Rares Candrea, Registered dietitian

CONTACT

+40 748 591 379; adelin.rare.candrea@elearn.umfcluj.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered dietitian, PhD(c)

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.
• Access Criteria: Access to de-identified and fully anonymized individual participant data will be granted to qualified researchers who provide a methodologically sound research proposal. Requests for data should be submitted upon request to the principal investigator or the corresponding author of the study publication. Only anonymized data will be shared following approval of the research proposal and in accordance with applicable ethical and data protection regulations.

Locations

RO (1)