Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647043
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Open-label Clinical Trial to Evaluate the Effect of SMT04 Pro in Irritable Bowel Syndrome IBS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBSXtra02
Brief 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
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 274 IBS-M 177 and IBS-U 177 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 125 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
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 125 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None