Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

NCT ID: NCT06647043

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-23
• Study Completion Date: 2025-09-30

Brief 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.

Detailed 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.

Conditions

Irritable Bowel Syndrome (IBS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SMT04 Pro

2 sachets daily for 3 months

Group Type: EXPERIMENTAL

SMT04 Pro

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

SMT04 Pro

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GenieBiome Limited

INDUSTRY

Sponsor Role: collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Lee Yeong Yeh

Professor Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yeong Yeh Lee

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Nik Nur Athirah Rohazman Affandi

Role: CONTACT

athirahaffandi22@gmail.com

+601161203432

Nur Diyana Mohamed Hashim

Role: CONTACT

nurdiyana@usm.my

+60139441057

Facility Contacts

Nik Nur Athirah Rohazman Affandi

Role: primary

athirahaffandi22@gmail.com

+6011-61203432

Nur Diyana Mohamed Hashim

Role: backup

nurdiyana@usm.my

+6013-9441057

References

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Other Identifiers

IBSXtra02 study

Identifier Type: -

Identifier Source: org_study_id