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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:
Participants will:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGR11 Synbiotic Formula Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGR11 synbiotic formula | Other | SGR11 is a synbiotic dietary supplement formulated to support gut microbial balance and intestinal health. It contains a combination of probiotic and prebiotic components designed to act synergistically to enhance microbial diversity, promote beneficial fermentation activity, and support mucosal barrier function. Participants will take the study product daily for 8 weeks. This formulation is distinguished by its specific synbiotic composition and its intended effects on gut microbiota-related pathways relevant to inflammatory bowel disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I) | 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. | 8 weeks after initiation of the study intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicia Chan | Contact | +852 2637 3260 | aliciachan@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong | ||||
| Prince of Wales Hospital |
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| Hong Kong |
| Hong Kong |
|
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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