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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in gastrointestinal symptom severity associated with Irritable Bowel Syndrome assessed by IBS Symptom Severity Score (IBS-SSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IBS group
Subjects diagnosed with IBS
干预措施: Synbiotic supplement containing probiotic strains, botanical extracts, magnesium, vitamin B1, and L-theanine designed to support gut microbiota balance. (Dietary Supplement)
结局指标
主要结局
Change in gastrointestinal symptom severity associated with Irritable Bowel Syndrome assessed by IBS Symptom Severity Score (IBS-SSS)
时间窗: 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.
次要结局
- Change in gut microbiota alpha diversity measured by 16S rRNA gene sequencing(From enrollment to the end of treatment at 16 weeks)
研究者
Candrea Rareș
Registered dietitian, PhD(c)
Iuliu Hatieganu University of Medicine and Pharmacy