Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

Launched by UNIVERSITI SAINS MALAYSIA · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effect of a health supplement called SMT04, which contains specific strains of probiotics, on patients with Irritable Bowel Syndrome (IBS). IBS is a common condition that causes symptoms like abdominal pain and changes in bowel habits, which can be uncomfortable and distressing. The goal of the trial is to see if taking SMT04 can help improve these symptoms by positively affecting the balance of bacteria in the gut.

To participate in the study, you must be between 18 and 70 years old and have been diagnosed with IBS, specifically the diarrhea or mixed types. You should also have had a negative colonoscopy in the last five years. Participants will need to complete some questionnaires and provide consent to join. Throughout the trial, you can expect to receive guidance and support from the research team. It's important to note that individuals with certain medical conditions or recent treatments that could interfere with the study will not be eligible. This trial is currently recruiting participants, so if you or a family member are interested, it could be a good opportunity to explore potential new treatment options for IBS.

Gender

ALL

Eligibility criteria

• 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