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

February 9, 2026 updated by: Siew Chien NG, Chinese University of Hong Kong

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
        • Principal Investigator:
          • Siew Chien Ng
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: SGR11 synbiotic formula
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I)
Time Frame: 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.
8 weeks after initiation of the study intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBD Synbiotic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Disease (IBD)

Clinical Trials on SGR11 synbiotic formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe