A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I)
研究概览
简要总结
The goal of this clinical trial is to find out whether a synbiotic formula (SGR11) can improve symptoms and health measures in people with inflammatory bowel disease (IBD). The main questions it aims to answer are:
- Does SGR11 lead to overall improvement in a participant's condition after 8 weeks, as measured by the Clinical Global Impression-Improvement Scale (CGI I)?
- Is SGR11 safe and well tolerated in people with IBD?
Participants will:
- Take the study synbiotic formula (SGR11) daily for 8 weeks
- Complete symptom and quality of life questionnaires
- Provide stool samples and, if applicable, blood samples to measure inflammation and gut microbiome changes
- Report any side effects that occur during the study
详细描述
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is characterized by chronic relapsing inflammation of the gastrointestinal tract driven by dysregulated immune responses to intestinal microbiota. Extensive evidence demonstrates that IBD is associated with marked gut microbiota dysbiosis, including loss of key short-chain fatty acid (SCFA)-producing taxa and enrichment of pro-inflammatory or mucosa-associated organisms. These microbial alterations contribute to impaired epithelial barrier integrity, shifts in microbial metabolite profiles, activation of mucosal immune pathways, and increased susceptibility to persistent intestinal inflammation. Additionally, IBS-like symptoms remain common among individuals with IBD, even during clinical remission, indicating ongoing functional and microbiota-related disturbances not fully addressed by conventional therapies.
Synbiotics, which combine probiotic and prebiotic components in a synergistic formulation, represent a promising therapeutic strategy targeting microbial and mucosal mechanisms relevant to IBD. Components within SGR11 have demonstrated potential in preclinical and clinical research to modulate intestinal inflammation, enhance epithelial barrier function, influence T-cell-mediated immune responses, improve microbial fermentation profiles, and support restoration of gut microbiota homeostasis. Prebiotic elements within synbiotic formulations may further promote beneficial microbial activity, reinforce mucosal structural integrity, and modulate host immune responses.
This pilot, single-arm clinical trial will evaluate the safety and preliminary efficacy of SGR11 over an 8-week intervention period in adults with IBD. The study will assess global clinical improvement, symptom indices, patient-reported outcomes, biochemical markers of intestinal inflammation and permeability, and gut microbiome composition and functional characteristics using stool-based assays
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18-75
- •Chinese ethnicity
- •Confirmed diagnosis of ulcerative colitis (UC) with mild to moderate disease activity, defined as a Simple Clinical Colitis Activity Index (SCCAI) of 3-5
- •On stable doses of IBD medication for ≥4 weeks prior to enrolment
- •Ability to provide written informed consent
- •Willingness to comply with study procedures
排除标准
- •Severe active IBD requiring hospitalization
- •Known history of severe organ failure (including decompensated cirrhosis, malignant disease, kidney failure, epilepsy, active serious infection, acquired immunodeficiency syndrome)
- •Presence of an ileostomy or colostomy
- •Severe comorbidities or immunocompromised states
- •Known current sepsis
- •Recent use of antibiotics, probiotics, or prebiotics within 4 weeks
- •Known pregnancy or breastfeeding
- •Known allergy or intolerance to study components
- •Inability to receive oral fluids
- •Participation in other interventional clinical trials within 30 days
研究组 & 干预措施
SGR11 Synbiotic Formula Arm
Participants in this arm will receive the synbiotic formula SGR11 for an 8-week intervention period. All participants will take the study product as directed and complete scheduled assessments, including symptom questionnaires, stool sample collection for microbiome and biomarker analysis, and safety monitoring throughout the study.
干预措施: SGR11 synbiotic formula (Other)
结局指标
主要结局
Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I)
时间窗: 8 weeks after initiation of the study intervention
Overall clinical improvement will be assessed using the Clinical Global Impression - Improvement scale (CGI-I), a clinician-rated measure evaluating change in a participant's condition relative to baseline.
次要结局
未报告次要终点
研究者
Siew Chien NG
Professor
Chinese University of Hong Kong