Clinical Trial

Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

Study acronym: IBSXtra02
Recruiting
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Record status
This record was last updated April 9, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Irritable Bowel Syndrome (IBS) is a brain-gut-disorder characterized by a chronic relapsing-remitting nature of symptoms, including abdominal pain and altered bowel habits. Symptoms most likely result from complex interactions between several biological, psychological and social factors. Probiotic supplements are thought to improve IBS symptoms through manipulation of the gut microbiota. Some studies have suggested that different strains of probiotics may improve abdominal pain and reduce visceral hypersensitivity by modulation of expression of neurotransmitters and receptors involved in the modulation of pain, such as the opioid receptor or the cannabinoid receptor. In addition, probiotics have been shown to reduce intestinal cytokine secretion and improve epithelial barrier function in a mice model of intestinal inflammation. Bifidobacteria and Streptococci strains had previously demonstrated efficacy in achieving symptom improvement in IBS patients. Thus, there is potential for SMT04, a health supplement, to be an option for IBS patients.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-15; most recent amendment 2025-04-06.
Status change: Not Yet Recruiting → Recruiting 2025-04-06
Trial Details
NCT Number NCT06647043
Lead Sponsor Universiti Sains Malaysia
Collaborators: GenieBiome Limited
Conditions Irritable Bowel Syndrome (IBS)
Enrollment 20 participants
Start Date 2025-02-23
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-09