Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

Phase

N/A

Condition

Gastroparesis

Colic

Non-ulcer Dyspepsia (Nud)

Treatment

SMT04 Pro

Clinical Study ID

NCT06647043

IBSXtra02 study

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The subject must meet all of the inclusion criteria to participate in this study.
Male or female,
Aged from 18 to 70 years old
Meet the criteria of the Rome-III-definition of IBS with diarrhoea or mixedsubtypes, or functional diarrhoea: Rome-III-definition: Abdominal pain orabdominal discomfort on minimum of three days per month during the last threemonths, starting at least six months ago, and a minimum of two of the followingcriteria:
Improvement of symptoms after defecation
Start of symptoms in association with a change in stool frequency
Start of symptoms in association with a change in stool consistencySubtype of IBS-D which requires more than 25% of your stools to be looseand less than 25% hard and lumpy; Subtype of IBS-M which your stools mustbe both hard and lumpy, as well as loose in consistency at least 25% ofthe time. Functional diarrhoea: The experience of loose or watery stoolswithout pain occurring in at least 75% of bowel movements for at leastthree months over the last six months.
Have the latest negative colonoscopy result within five years
Literate and can complete questionnaire
Written informed consent is obtained

Exclusion

Exclusion Criteria:

• Known inflammatory bowel disease, lactose intolerance or other malabsorptionsyndromes, celiac disease, diabetes mellitus, thyroid disfunction, cancer,immunodeficiency, autoimmune diseases, severe hepatic or renal insufficiency, otherexplainable causes of abdominal pain, diarrhoea or constipation
Known operations involving small intestines and large intestines; or history ofappendectomy, hysterectomy, and cholecystectomy in last 6 months
Known severe mental illnesses; unstable type or dose of psychiatric drugswithin the last 3 months that will affect their judgement of studyparticipation
Evidence of active infection at the time of inclusion
History of use of prebiotics, probiotics, antibiotic therapy oranti-inflammatory drugs within the last 2 weeks
Known current pregnancy or breast-feeding female

Study Design

SMT04 Pro

February 23, 2025

September 30, 2025

Study 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.

Connect with a study center

Universiti Sains Malaysia
Kubang Kerian, Kelantan 16150
Malaysia
Active - Recruiting

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