Efficacy of PosBion® Postbiotic Supplementation in Adults With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Score
研究概览
简要总结
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits, often associated with impaired intestinal barrier function, low-grade inflammation, and dysregulation of the gut-brain axis. Postbiotics have emerged as a promising therapeutic approach due to their immunomodulatory, anti-inflammatory, and gut barrier-protective properties.
This completed single-arm, open-label clinical study evaluated the efficacy of PosBion® postbiotic supplementation in adults with IBS over a 12-week intervention period. The study assessed changes in IBS symptom severity, quality of life, gastrointestinal health, inflammatory biomarkers, intestinal barrier integrity, mucosal immunity, oxidative stress, and gut-brain axis biomarkers using validated questionnaires and salivary biomarker analyses.
详细描述
Irritable bowel syndrome (IBS) is one of the most prevalent disorders of gut-brain interaction, affecting millions of individuals worldwide and substantially impairing quality of life. Increasing evidence suggests that IBS is associated with intestinal dysbiosis, impaired intestinal barrier function, microbial translocation, low-grade inflammation, oxidative stress, altered mucosal immunity, and dysregulation of the gut-brain axis. These interconnected mechanisms represent important therapeutic targets for nutritional interventions.
Postbiotics, consisting of inactivated microorganisms and their bioactive components, have attracted increasing attention due to their safety, stability, and potential health benefits. Experimental and clinical studies suggest that postbiotics may improve intestinal homeostasis by strengthening epithelial barrier integrity, modulating immune responses, suppressing intestinal inflammation, and regulating host-microbiota interactions.
This completed prospective, single-arm, open-label clinical study investigated the efficacy of PosBion® postbiotic supplementation in adults with IBS. Fifty-five subjects were enrolled, of whom fifty completed the 12-week intervention. Subjects consumed two sachets of PosBion® daily throughout the study period.
Clinical efficacy was evaluated using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire, and a gastrointestinal health visual analogue scale (GI Health VAS). To investigate the potential mechanisms underlying the intervention, serial saliva samples were collected at baseline and during follow-up visits for biomarker analyses.
Inflammatory responses were assessed by measuring salivary calprotectin, interleukin-1β (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), lactoferrin, and myeloperoxidase (MPO). Intestinal barrier integrity and intestinal permeability were evaluated using salivary zonulin, lipopolysaccharide (LPS), and lipopolysaccharide-binding protein (LBP). Mucosal immune function was assessed using secretory immunoglobulin A (sIgA), while oxidative stress was evaluated by measuring salivary malondialdehyde (MDA). Gut-brain axis responses were assessed using salivary cortisol and serotonin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced one or more symptoms consistent with irritable bowel syndrome (IBS), including:
- •Stomach pain or abdominal cramps
- •Excessive gas
- •Diarrhoea
- •Constipation (or alternating diarrhoea and constipation)
- •Mucus in stool
- •Urgency to defecate
- •Sensation of incomplete bowel evacuation
- •Willing and able to comply with all study procedures and scheduled visits.
- •Provided written informed consent before study participation.
排除标准
- •History of chronic or serious medical conditions, including but not limited to diabetes mellitus, cardiovascular disease, chronic kidney disease, cancer, or chronic respiratory disease.
- •Current use of supplements intended to improve gut health.
- •Current use of antibiotics or antiviral medications.
- •Current use of probiotic, prebiotic, or postbiotic supplements.
- •Major surgery within the previous 6 months.
- •Pregnant or breastfeeding women.
- •Known allergy or hypersensitivity to any ingredient of the investigational product.
- •Any condition that, in the opinion of the investigators, could interfere with study participation, compliance, or interpretation of the study results.
研究组 & 干预措施
PosBion® Postbiotic Supplementation
Subjects received PosBion® postbiotic supplementation for 12 weeks. Each sachet contained Lactobacillus plantarum RS5 (2,500 mg) and Lactobacillus plantarum RI11 (2,500 mg). Subjects were instructed to consume two sachets daily throughout the intervention period. Clinical assessments and saliva samples were collected at baseline and at Weeks 4, 8, and 12 to evaluate changes in IBS symptoms, quality of life, gastrointestinal health, inflammatory biomarkers, intestinal barrier function, mucosal immunity, oxidative stress, and gut-brain axis biomarkers.
干预措施: Postbiotic supplementation (Dietary Supplement)
结局指标
主要结局
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Score
时间窗: Baseline, Week 4, Week 8, and Week 12
IBS-related quality of life was assessed using the 34-item Irritable Bowel Syndrome Quality of Life questionnaire. Raw item scores were transformed to a total score ranging from 0 to 100. Higher scores indicate better IBS-related quality of life and a better outcome.
Change in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) Score
时间窗: Baseline, Week 4, Week 8, and Week 12
Irritable bowel syndrome symptom severity was assessed using the 5-item Irritable Bowel Syndrome Symptom Severity Scale. The scale evaluates abdominal pain severity, abdominal pain frequency, abdominal distension, dissatisfaction with bowel habits, and interference with daily life. The total score ranges from 0 to 500, with higher scores indicating more severe IBS symptoms and a worse outcome.
次要结局
- Change in Salivary Calprotectin Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Interleukin-1β (IL-1β) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Interleukin-6 (IL-6) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Interleukin-8 (IL-8) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Lactoferrin Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Myeloperoxidase (MPO) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Zonulin Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Lipopolysaccharide (LPS) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Lipopolysaccharide-Binding Protein (LBP) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Secretory Immunoglobulin A (sIgA) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Malondialdehyde (MDA) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Cortisol Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Salivary Serotonin Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Gastrointestinal Health Visual Analogue Scale (GI Health VAS)(Baseline, Week 4, Week 8, and Week 12)