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

March 14, 2026 updated by: Candrea Rareș, Iuliu Hatieganu University of Medicine and Pharmacy

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The human gut microbiota represents a complex ecosystem composed of trillions of microorganisms that play a fundamental role in maintaining host health. These microorganisms contribute to digestion, nutrient metabolism, immune modulation, and the maintenance of intestinal barrier integrity. Alterations in the composition and diversity of the gut microbiota, commonly referred to as dysbiosis, have been associated with a wide range of metabolic, inflammatory, and gastrointestinal disorders.

Among these conditions, Irritable Bowel Syndrome (IBS) is one of the most prevalent functional gastrointestinal disorders worldwide. IBS is characterized by chronic or recurrent abdominal pain, bloating, gas, and alterations in bowel habits, including constipation, diarrhea, or alternating patterns. Although the exact pathophysiology of IBS remains incompletely understood, increasing evidence suggests that alterations in gut microbiota composition and intestinal barrier function play an important role in symptom development and persistence.

Recent research has explored the use of probiotics and synbiotics as potential strategies to modulate gut microbiota and improve gastrointestinal symptoms. Probiotics are live microorganisms that, when administered in adequate amounts, may confer health benefits to the host by restoring microbial balance, enhancing mucosal barrier function, and modulating immune responses. Synbiotics combine probiotics with compounds that support their activity, such as prebiotic substrates or bioactive plant components.

In addition to probiotics, several plant-derived compounds have been investigated for their potential effects on gut microbiota and intestinal health. Botanical extracts rich in polyphenols and other bioactive compounds may exert antioxidant, anti-inflammatory, and prebiotic-like effects, supporting beneficial microbial populations and contributing to improved intestinal homeostasis. Nutritional cofactors, such as magnesium and vitamin B1, have also been linked to gut microbial metabolism and intestinal barrier function. Moreover, L-theanine, a bioactive compound derived from green tea leaves, has been studied for its potential role in modulating gut microbiota and immune responses.

The investigational product used in this study, TERRANOVA Microbiome Challenge, is a synbiotic dietary supplement that combines multiple probiotic strains with a botanical matrix and nutritional cofactors. The formulation includes probiotic strains such as Bacillus coagulans, Bifidobacterium bifidum, Lactocaseibacillus rhamnosus, and Lactiplantibacillus plantarum. The botanical matrix contains extracts from Cynara scolymus (artichoke leaf), Zingiber officinale (ginger root), Vaccinium myrtillus (bilberry), Matricaria recutita (chamomile flower), and Melissa officinalis (lemon balm leaf). The formulation also contains magnesium, vitamin B1, and L-theanine.

While individual components of this formulation have been investigated in preclinical and clinical studies, the combined effects of this specific synbiotic formulation on gut microbiota composition and IBS-related symptoms have not yet been evaluated in a clinical setting. Therefore, this study aims to explore the potential effects of this synbiotic supplement on gastrointestinal symptoms, biological markers, and gut microbiota composition in adults diagnosed with IBS.

This study is designed as a pilot, prospective, longitudinal clinical study with an intra-subject before-after design. A small exploratory sample of adult participants diagnosed with IBS will be included. The study will evaluate changes in symptoms, biological parameters, and gut microbiota over time within the same individuals.

The study will be conducted in three main phases over a total duration of approximately 16 weeks per participant.

During the first visit (baseline, T0), participants will undergo an initial clinical evaluation and complete standardized questionnaires assessing gastrointestinal symptoms. Blood samples will be collected to evaluate safety parameters, including hepatic, renal, inflammatory, and hematological markers. Stool samples will also be collected for gut microbiota analysis using 16S rRNA sequencing techniques.

The first phase of the study will consist of an observation period lasting eight weeks without the investigational intervention. This phase aims to establish a reference period and to reduce the influence of spontaneous symptom variability commonly observed in IBS. At the end of this observation period (T1), participants will undergo a second evaluation including symptom assessment, blood tests, and stool sample collection.

Following this period, participants will enter the intervention phase. During this phase, participants will receive the investigational synbiotic supplement for eight weeks. The supplement will be administered orally at a dose of one capsule per day, preferably after a meal, according to the manufacturer's recommendations.

Participants will be instructed to maintain their usual diet and lifestyle during the study and to avoid the use of additional probiotic or prebiotic supplements that could influence gut microbiota composition.

At the final visit (Tfinal), which takes place after completion of the eight-week supplementation period, participants will again undergo clinical evaluation, symptom assessment, blood testing, and gut microbiota analysis.

The primary objective of this study is to evaluate changes in gastrointestinal symptoms associated with IBS between baseline and the end of the study using standardized symptom assessment tools.

Secondary objectives include evaluating changes in selected biological markers, assessing changes in gut microbiota composition over time, exploring potential relationships between symptom changes and microbiota alterations, and evaluating adherence and tolerability of the intervention.

Safety monitoring will be conducted throughout the study. Participants will be asked to report any adverse events or changes in health status. Known potential side effects associated with probiotic supplementation, such as mild gastrointestinal discomfort, bloating, or changes in stool consistency, will be monitored. Any adverse events will be documented and evaluated by the research team.

The study will be conducted in accordance with the principles of the Declaration of Helsinki and applicable national regulations governing biomedical research involving human participants. Participation in the study will be voluntary, and all participants will provide written informed consent prior to enrollment. Participant confidentiality will be ensured through the use of coded identifiers and secure data storage procedures.

Due to the exploratory nature of this pilot study and the small sample size, statistical analyses will primarily be descriptive and exploratory. Comparisons will focus on intra-individual changes across the different study time points. The findings of this study are expected to provide preliminary insights into the potential role of synbiotic supplementation in the modulation of gut microbiota and symptom management in individuals with IBS, and may inform the design of larger controlled clinical trials in the future.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Cluj-Napoca, Romania, 400337
        • Department of Pharmaceutical Botany, Univeristy of Medicine and Pharmacy "Iuliu Hațieganu", 23 Gheorghe Marinescu Street, 3rd Floor, Cluj-Napoca, Romania
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBS group
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.
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.
Other Names:
  • TERRANOVA Microbiome Challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gastrointestinal symptom severity associated with Irritable Bowel Syndrome assessed by IBS Symptom Severity Score (IBS-SSS)
Time Frame: From enrollment to the end of treatment at 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gut microbiota alpha diversity measured by 16S rRNA gene sequencing
Time Frame: From enrollment to the end of treatment at 16 weeks
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.
From enrollment to the end of treatment at 16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum AST levels
Time Frame: From enrollment to the end of treatment at 16 weeks
Serum aspartate aminotransferase levels will be measured in blood samples collected during the study to assess potential changes associated with the intervention.
From enrollment to the end of treatment at 16 weeks
Change in stool consistency assessed by Bristol Stool Form Scale
Time Frame: Baseline to week 16
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.
Baseline to week 16
Change in serum alanine aminotransferase (ALT) levels
Time Frame: Baseline to week 16
Serum alanine aminotransferase levels will be measured in blood samples collected during the study to monitor potential changes over time.
Baseline to week 16
Change in serum gamma-glutamyl transferase (GGT) levels
Time Frame: Baseline to week 16
Serum gamma-glutamyl transferase levels will be measured in blood samples collected during the study to monitor potential hepatic safety changes.
Baseline to week 16
Change in erythrocyte sedimentation rate (ESR)
Time Frame: Baseline to week 16
Erythrocyte sedimentation rate will be measured in blood samples collected during the study to assess changes in systemic inflammatory status.
Baseline to week 16
Change in C-reactive protein (CRP) levels
Time Frame: Baseline to week 16
Serum C-reactive protein levels will be measured in blood samples collected during the study to evaluate changes in systemic inflammation.
Baseline to week 16
Change in serum creatinine levels
Time Frame: Baseline to week 16
Serum creatinine levels will be measured in blood samples collected during the study to monitor renal function over time.
Baseline to week 16
Change in glomerular filtration rate (eGFR)
Time Frame: Baseline to week 16
Estimated glomerular filtration rate will be calculated using serum creatinine measurements to evaluate renal function during the study period.
Baseline to week 16
Change in serum urea levels
Time Frame: Baseline to week 16
Serum urea levels will be measured in blood samples collected during the study to monitor renal function during the intervention.
Baseline to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP75/06.03.2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in the publication will be made available to qualified researchers upon reasonable request to the principal investigator. Data will be shared after publication of the study results, provided that the proposed use of the data is scientifically sound and approved by the study investigators, in accordance with applicable ethical and data protection regulations.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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