A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)

NCT07411131 | Not Yet Recruiting

• 1 other identifier: IBD Synbiotic
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC)

Keywords

Inflammatory Bowel Disease; Ulcerative Colitis; Synbiotic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: SGR11 synbiotic formula

Interventions

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.

SGR11 Synbiotic Formula Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Alicia Chan

CONTACT

+852 2637 3260; aliciachan@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

HK (2)