Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000, Malaysia
Location status: Recruiting
NCT Number: NCT06595719
Probiotics are one of the adjunctive treatments that have been extensively explored for Ulcerative colitis (UC) disease management. Probiotics, a group of beneficial bacteria, can bring various health benefits when adequately supplied to the body, especially for gut wellness. In particular, for UC patients, gut dysbiosis is one of the contributing factors in their pathogenesis. Thus, the supplementation of probiotics in combination with standard treatment can potentially help in relieving symptoms as well as promoting mucosal healing for long-term remission.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Cheras, Kuala Lumpur, 56000, Malaysia
Location status: Recruiting
Inflammatory bowel disease (IBD) has progressively risen globally, becoming more prevalent in recent years. Crohn's disease (CD) and UC are classified as two of IBD variations resulting in range of symptoms that can negatively impact patients' quality of life. The underlying cause of UC is complicated, encompassing genetic, environmental, and immunological factors. Despite breakthroughs in medical treatment, obtaining and maintaining remission in UC remains a substantial challenge, especially for people with mild to moderate disease severity. Standard treatment for UC consists of anti-inflammatory drugs, antibiotics, immunosuppressants, and, in severe instances, biologic therapy and possibly surgery. While these procedures have proven effective, a significant proportion of patients endure ongoing symptoms or undesirable consequences, emphasizing the need for alternative or supplementary therapeutic options.
In recent years, studies have focused on the gut microbiota as an important contributor in the pathophysiology of UC. Individuals with UC frequently exhibit altered microbial composition and dysbiosis, implying a possible role for gut microbiome-modulating therapies. Probiotics, which are live microorganisms that provide health advantages have emerged as a viable area for research in UC management. The rationale for using probiotics in UC lies in their potential to restore microbial balance, strengthen the intestinal barrier, and modulate the immune response. Previous studies have shown varying degrees of success with probiotics administration in terms of clinical and laboratory outcomes.
This proposed research seeks to contribute to the growing body of knowledge on the role of probiotics in UC by evaluating the efficacy of a multi-strain probiotic supplement. By combining these probiotics with standard care, we aim to explore the synergistic effects that may lead to improved clinical outcomes, endoscopic remission, and enhanced quality of life in individuals with mild to moderate UC. Understanding the impact of multi-strain probiotics on UC could provide clinicians with a valuable adjunctive tool for UC treatment strategies. Furthermore, elucidating the underlying mechanisms by which probiotics exert their effects enable better knowledge regarding the interplay between the gut microbiota and UC management. Thus, it can bring benefits to both patients and health institutions which helped in reducing the cost and maintaining long term remission.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each sachet of the multi-strain probiotics contain 30 billion CFU of 6 strains which includes Lactobacillus acidophilus BCMC®12130, Lactobacillus casei subsp BCMC®12313, Lactobacillus lactis BCMC®12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium infantis BCMC®02129, Bifidobacterium longum BCMC®02120
Replicate for multi-strain probiotics without any active ingredients
Time frame: 12 weeks
The composition, diversity, and core microbiome of the gut bacterial community were identified via 16S rRNA sequencing and compared before and after taking multi-strain probiotics or placebo.
Time frame: 12 weeks
Level of faecal calprotectin (mg/kg) measured before and after treatment with multi-strain probiotics or placebo, indicating levels of intestinal inflammation.
Time frame: 12 weeks
Level of CRP (mg/dl) measured before and after treatment with multi-strain probiotics or placebo, reflecting changes in systemic inflammation.
Time frame: 12 weeks
Rate of erythrocyte sedimentation (mm/hr) measured before and after treatment with multi-strain probiotics or placebo, as a marker of inflammation.
Time frame: 12 weeks
Number of participants with changes in WBC count (x10^9/L) measured before and after treatment with multi-strain probiotics or placebo, to assess immune response and inflammation levels.
Time frame: 12 weeks
Identification and quantification of serum metabolites via Liquid Chromatography-Mass Spectrometry (LC-MS) before and after treatment with multi-strain probiotics or placebo. The changes in metabolite concentrations will be compared to assess the metabolic response to the intervention.
Time frame: 12 weeks
Quantification of IL5, IL6, IL13, IL33, and TNFα gene expression using quantitative PCR (qPCR) before and after treatment with multi-strain probiotics or placebo. The changes in gene expression levels will be compared to evaluate the impact on proinflammatory cytokines.
Time frame: 12 weeks
Assessment of disease severity using the Partial Mayo Score, a scale ranging from 0 to 9, where higher scores indicate worse disease severity. The PMS was used during the screening process to identify mild to moderate UC patients, and was also measured after 12 weeks of intervention during post-treatment sample collection to evaluate changes in disease severity.
Time frame: 12 weeks
Physical activity was assessed using the International Physical Activity Questionnaire (IPAQ), completed by participants before and after treatment with multi-strain probiotics or placebo. The total weekly minutes for each domain (e.g., walking, moderate activity, vigorous activity) will be summed to estimate the participant's overall physical activity level.
Time frame: 12 weeks
Quality of Life (QoL) was assessed through patient-completed questionnaires before and after treatment with multi-strain probiotics or placebo. Total scores will be calculated, with higher or lower scores indicating the patient's overall QoL. The change in scores will be used to determine the impact of the intervention on QoL.
Time frame: 12 weeks
Dietary intake over the past three days was recorded by participants using a Three-Days Food Record before and after treatment with multi-strain probiotics or placebo. The data will be used to assess changes in participants' dietary patterns and nutrient intake prior to sample collection.
Time frame: 12 weeks
At the end of the 12-week intervention, participants completed a Diet History Questionnaire to report their intake of probiotics-based foods, including conventional and local foods. This data will provide insight into the participants' consumption of probiotics-based foods during the intervention period, helping to account for potential bias in the study.
Contact information is provided by the study sponsor or research team.
Norfilza M Mokhtar, MD, MMedSci, PhD
CONTACT
Raja Affendi Raja Ali, MBBChBaO,MD,MMedSci,MBA,CCST
CONTACT
National University of Malaysia
Other
Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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