Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome
ConditionIrritable Bowel Syndrome (IBS)
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SMT04 Pro
Dietary supplementConsists of a blend of food-grade Bifidobacterium as active probiotics
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: SMT04 ProExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The improvement of IBS severity using IBS severity scoring system (IBS-SSS) at month 3 after taking SMT04 Pro.
The IBS-SSS score will be used to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS. The higher the score, the worsening of the symptoms.
Time frame
3 monthsSecondary outcomes
1
The change in gastrointestinal symptoms at month 3.
This assessment is to compare the symptom status ranging from XXX to XXX at month 3 compared to baseline. Binary outcome of Yes and No will be used.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universiti Sains Malaysia
Lead sponsor
GenieBiome Limited
Collaborator
Source ClinicalTrials.gov