Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversiti Sains Malaysia

About this trial

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

Qualifiers

The subject must meet all of the inclusion criteria to participate in this study.

Male or female,

Aged from 18 to 70 years old

Improvement of symptoms after defecation

Disqualifiers

• 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

Trial design

Treatments tested in this trial

  • SMT04 Pro

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Universiti Sains Malaysia

Lead sponsor

GenieBiome Limited

Collaborator