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RECRUITING

NCT06647043

Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

Sponsor: Universiti Sains Malaysia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-23

Completion Date

2025-09-30

Last Updated

2025-04-09

Healthy Volunteers

Conditions

Irritable Bowel Syndrome (IBS)

Interventions

DIETARY_SUPPLEMENT

SMT04 Pro

Consists of a blend of food-grade Bifidobacterium as active probiotics

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 mixed subtypes, or functional diarrhoea: Rome-III-definition: Abdominal pain or abdominal discomfort on minimum of three days per month during the last three months, starting at least six months ago, and a minimum of two of the following criteria: * 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 consistency Subtype of IBS-D which requires more than 25% of your stools to be loose and less than 25% hard and lumpy; Subtype of IBS-M which your stools must be both hard and lumpy, as well as loose in consistency at least 25% of the time. Functional diarrhoea: The experience of loose or watery stools without pain occurring in at least 75% of bowel movements for at least three 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 Criteria: * • Known inflammatory bowel disease, lactose intolerance or other malabsorption syndromes, celiac disease, diabetes mellitus, thyroid disfunction, cancer, immunodeficiency, autoimmune diseases, severe hepatic or renal insufficiency, other explainable causes of abdominal pain, diarrhoea or constipation * Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months * Known severe mental illnesses; unstable type or dose of psychiatric drugs within the last 3 months that will affect their judgement of study participation * Evidence of active infection at the time of inclusion * History of use of prebiotics, probiotics, antibiotic therapy or anti-inflammatory drugs within the last 2 weeks * Known current pregnancy or breast-feeding female

Locations (1)

Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia