Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

NCT06647043 | Recruiting

• 1 other identifier: IBSXtra02 study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome (IBS); Synbiotics

Outcome Measures

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.

  3 months

Secondary Outcomes (1)

• The change in gastrointestinal symptoms at month 3.

  3 months

Study Arms (1)

SMT04 Pro

EXPERIMENTAL

2 sachets daily for 3 months

Dietary Supplement: SMT04 Pro

Interventions

SMT04 Pro DIETARY_SUPPLEMENT

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

SMT04 Pro

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of use of prebiotics, probiotics, antibiotic therapy or anti-inflammatory drugs within the last 2 weeks
• Known current pregnancy or breast-feeding female

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• GenieBiome Limited: collaborator

Study Sites (1)

Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (10)

• 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.

  PMID: 34599559 BACKGROUND

• 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.

  PMID: 27595104 BACKGROUND

• 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.

  PMID: 11522742 BACKGROUND

• 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.

  PMID: 16105890 BACKGROUND

• 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.

  PMID: 17159985 BACKGROUND

• 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.

  PMID: 24979556 BACKGROUND

• 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.

  PMID: 31080615 BACKGROUND

• 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.

  PMID: 12864966 BACKGROUND

• 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.

  PMID: 22426087 BACKGROUND

• 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.

  PMID: 23066308 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yeong Yeh Lee

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nik Nur Athirah Rohazman Affandi

CONTACT

+601161203432; athirahaffandi22@gmail.com

Nur Diyana Mohamed Hashim

CONTACT

+60139441057; nurdiyana@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Model Details: All study subjects will receive the same study products for 3 months.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: February 23, 2025
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 9, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)