Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome (IBSXtra02)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Dietary supplement: SMT04 Pro

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nik Nur Athirah Rohazman Affandi; Phone Number: +601161203432; Email: athirahaffandi22@gmail.com
• Study Contact Backup: Name: Nur Diyana Mohamed Hashim; Phone Number: +60139441057; Email: nurdiyana@usm.my

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Recruiting
      • Universiti Sains Malaysia
      • Contact: Nik Nur Athirah Rohazman Affandi; Phone Number: +6011-61203432; Email: athirahaffandi22@gmail.com
      • Contact: Nur Diyana Mohamed Hashim; Phone Number: +6013-9441057; Email: nurdiyana@usm.my
      • Contact: Yeong Yeh Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMT04 Pro; 2 sachets daily for 3 months	Dietary supplement: SMT04 Pro; Consists of a blend of food-grade Bifidobacterium as active probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Collaborators: GenieBiome Limited
• Investigators: Principal Investigator: Yeong Yeh Lee, Universiti Sains Malaysia

Publications and helpful links

General Publications

• Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
• Madsen K, Cornish A, Soper P, McKaigney C, Jijon H, Yachimec C, Doyle J, Jewell L, De Simone C. Probiotic bacteria enhance murine and human intestinal epithelial barrier function. Gastroenterology. 2001 Sep;121(3):580-91. doi: 10.1053/gast.2001.27224.
• Rousseaux C, Thuru X, Gelot A, Barnich N, Neut C, Dubuquoy L, Dubuquoy C, Merour E, Geboes K, Chamaillard M, Ouwehand A, Leyer G, Carcano D, Colombel JF, Ardid D, Desreumaux P. Lactobacillus acidophilus modulates intestinal pain and induces opioid and cannabinoid receptors. Nat Med. 2007 Jan;13(1):35-7. doi: 10.1038/nm1521. Epub 2006 Dec 10.
• Van den Houte K, Carbone F, Pannemans J, Corsetti M, Fischler B, Piessevaux H, Tack J. Prevalence and impact of self-reported irritable bowel symptoms in the general population. United European Gastroenterol J. 2019 Mar;7(2):307-315. doi: 10.1177/2050640618821804. Epub 2018 Dec 22.
• Jafari E, Vahedi H, Merat S, Momtahen S, Riahi A. Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating. Arch Iran Med. 2014 Jul;17(7):466-70.
• Mezzasalma V, Manfrini E, Ferri E, Sandionigi A, La Ferla B, Schiano I, Michelotti A, Nobile V, Labra M, Di Gennaro P. A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation. Biomed Res Int. 2016;2016:4740907. doi: 10.1155/2016/4740907. Epub 2016 Aug 9. Erratum In: Biomed Res Int. 2019 Apr 9;2019:9042956. doi: 10.1155/2019/9042956.
• Tornkvist NT, Aziz I, Whitehead WE, Sperber AD, Palsson OS, Hreinsson JP, Simren M, Tornblom H. Health care utilization of individuals with Rome IV irritable bowel syndrome in the general population. United European Gastroenterol J. 2021 Dec;9(10):1178-1188. doi: 10.1002/ueg2.12153. Epub 2021 Oct 1.
• Verdu EF, Bercik P, Verma-Gandhu M, Huang XX, Blennerhassett P, Jackson W, Mao Y, Wang L, Rochat F, Collins SM. Specific probiotic therapy attenuates antibiotic induced visceral hypersensitivity in mice. Gut. 2006 Feb;55(2):182-90. doi: 10.1136/gut.2005.066100. Epub 2005 Aug 16.
• Lea R, Whorwell PJ. New insights into the psychosocial aspects of irritable bowel syndrome. Curr Gastroenterol Rep. 2003 Aug;5(4):343-50. doi: 10.1007/s11894-003-0073-z.
• El-Salhy M. Irritable bowel syndrome: diagnosis and pathogenesis. World J Gastroenterol. 2012 Oct 7;18(37):5151-63. doi: 10.3748/wjg.v18.i37.5151.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome (IBS); Synbiotics
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Syndrome
• Other Study ID Numbers: IBSXtra02 study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No