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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese University of Hong Kong

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • SGR11 synbiotic formula

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: SGR11 Synbiotic Formula ArmExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
8 weeks after initiation of the study intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: