NCT06647043

Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 Pro in Irritable Bowel Syndrome (IBS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Irritable Bowel Syndrome (IBS) is a common functional bowel disorder characterized by a chronic relapsing-remitting nature of symptoms, including abdominal pain and altered bowel habits. IBS is categorized into four subtypes based on the predominant stool pattern: diarrhoea (IBS-D), constipation (IBS-C), a mix of diarrhoea and constipation (IBS-M) or undefined predominant stool form (IBS-U). The distribution in terms of the predominant stool patterns was IBS-D 37%, IBS-C 27.4%, IBS-M 17.7% and IBS-U 17.7%. Symptoms most likely result from complex interactions between several biological, psychological and social factors and the concept of a brain-gut axis has been evoked. IBS is a heterogeneous disorder with varying treatments targeted at the predominant symptoms. The optimal approach for any individual can be difficult to determine. Treatment options include both dietary modifications and drug therapies. IBS symptoms are experienced as troublesome for those affected and the condition is associated with increased rates of depression and anxiety, as well as economic challenges, and severe reduction in quality of life (QoL). Neither pharmacological treatment nor diet changes completely eliminate symptoms. Therefore, alternative approaches to improve symptoms and QoL for those affected are needed. The overall data from gut microbiome research support the approach of adopting novel therapeutic strategies that target the dysbiotic gut for improving gastrointestinal symptoms in IBS. Although probiotic supplements improve IBS symptoms, the precise composition of probiotics that can achieve optimal response remains unclear. SMT04 Pro (GenieBiome (Malaysia) Sdn. Bhd.) is a novel product that is commercially available in Malaysia. It consists of a patented probiotics blend (3 Bifidobacteria, 1 Streptococci, 12.5 billion CFU in 1 sachet). Bifidobacteria and Streptococci strains have been shown to improve in IBS patients. Thus, there is potential for SMT04 Pro, a health supplement, to be an option for IBS patients.

Conditions

• Irritable Bowel Syndrome (IBS)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SMT04 Pro	Consists of a blend of food-grade Bifidobacterium as active probiotics

Timeline

• Start date: 2025-02-23
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2024-10-17
• Last updated: 2025-04-09

Locations

1 site across 1 country: Malaysia