Ulcerative ColitisNCT06595719
Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
A study testing Multi-Strain Probiotics in people with Ulcerative Colitis, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Multi-Strain Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Feb 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of UC established by previous colonoscopy, with consistent histology, and clinical course.
- UC involving at least the rectosigmoid, actively confirmed by colonoscopy at the beginning of the study.
- Mild to moderate disease activity, defined as a PMS ranging from 3-8.
- Use of medication at least 4 weeks prior to study.
Who cannot join
- Crohn's disease or pouchitis.
- Severe disease activity as defined in PMS, more than 8.
- Use of antibiotics within the last 2 weeks before study entry.
- Change in dose of medication within the last 4 weeks before study entry and throughout the 12-week study period.
- Use of probiotics preparation either prescribed or over the counter within 2 weeks before the study entry.
- Use of NSAIDs for 1 week before and throughout the 12-week study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
About this study
Official title: Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics
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.
Read the detailed description
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Multi-Strain Probiotics, Placebo
- Keywords
- Probiotics, Inflammatory Bowel Disease, Gut microbiota
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Strain ProbioticsDietary supplement
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
PlaceboDietary supplement
Replicate for multi-strain probiotics without any active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Probiotics with standard care | Experimental | 62 mild to moderate UC patients were supplemented with multi-strain probiotics consisting of 6 active strains from Bifidobacterium and Lactobacillus species for 12 weeks. Receives: Dietary Supplement: Multi-Strain Probiotics |
| Placebo with standard care | Placebo comparator | 62 mild to moderate UC patients were supplemented with placebo, containing no active bacteria strains for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome analysis
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.
Measured: 12 weeks
Faecal Calprotectin Level
Level of faecal calprotectin (mg/kg) measured before and after treatment with multi-strain probiotics or placebo, indicating levels of intestinal inflammation.
Measured: 12 weeks
C-reactive Protein (CRP) Level
Level of CRP (mg/dl) measured before and after treatment with multi-strain probiotics or placebo, reflecting changes in systemic inflammation.
Measured: 12 weeks
Erythrocyte Sedimentation Rate (ESR) Level
Rate of erythrocyte sedimentation (mm/hr) measured before and after treatment with multi-strain probiotics or placebo, as a marker of inflammation.
Measured: 12 weeks
Change in White Blood Cell (WBC) Count
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.
Measured: 12 weeks
Change in Serum Metabolite Profile
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.
Measured: 12 weeks
Change in Proinflammatory Cytokine Gene Expression
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.
Measured: 12 weeks
Secondary outcomes (5)
Partial Mayo score (PMS)
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.
Measured: 12 weeks
International Physical Activity Questionnaire (IPAQ)
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.
Measured: 12 weeks
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
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.
Measured: 12 weeks
Three Days Food Record
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.
Measured: 12 weeks
Diet History Questionnaire
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Feb 2024
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595719
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2023-852
- Status last verified
- Mar 2025
- First submitted
- 3 Sep 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No The investigators are bound to the Institutional Review Board Universiti Kebangsaan Malaysia Medical Research Ethics Committee rules and regulations where recruited patients identity and data are kept confidential and will only be allowed to access by the research team.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics
- ClinicalTrials.gov ID
- NCT06595719
- Acronym / sponsor ID
- UKM PPI/111/8/JEP-2023-852
- Conditions
- Ulcerative Colitis
- Keywords
- Probiotics, Inflammatory Bowel Disease, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics with standard care | Experimental | Dietary Supplement: Multi-Strain Probiotics62 mild to moderate UC patients were supplemented with multi-strain probiotics consisting of 6 active strains from Bifidobacterium and Lactobacillus species for 12 weeks. |
| Placebo with standard care | Placebo comparator | Dietary Supplement: Placebo62 mild to moderate UC patients were supplemented with placebo, containing no active bacteria strains for 12 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of UC established by previous colonoscopy, with consistent histology, and clinical course.
- UC involving at least the rectosigmoid, actively confirmed by colonoscopy at the beginning of the study.
- Mild to moderate disease activity, defined as a PMS ranging from 3-8.
- Use of medication at least 4 weeks prior to study.
Key exclusion criteria (6 listed)
- Crohn's disease or pouchitis.
- Severe disease activity as defined in PMS, more than 8.
- Use of antibiotics within the last 2 weeks before study entry.
- Change in dose of medication within the last 4 weeks before study entry and throughout the 12-week study period.
- Use of probiotics preparation either prescribed or over the counter within 2 weeks before the study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Strain ProbioticsEach 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 | Dietary supplement | Probiotics with standard care |
| PlaceboReplicate for multi-strain probiotics without any active ingredients | Dietary supplement | Placebo with standard care |
Primary outcome
Gut microbiome analysis
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.
Faecal Calprotectin Level
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.
C-reactive Protein (CRP) Level
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.
Erythrocyte Sedimentation Rate (ESR) Level
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.
Change in White Blood Cell (WBC) Count
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.
Change in Serum Metabolite Profile
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.
Change in Proinflammatory Cytokine Gene Expression
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.
5 secondary outcomes
Partial Mayo score (PMS)
Time frame: 12 weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: 12 weeks
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: 12 weeks
Three Days Food Record
Time frame: 12 weeks
Diet History Questionnaire
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No. No The investigators are bound to the Institutional Review Board Universiti Kebangsaan Malaysia Medical Research Ethics Committee rules and regulations where recruited patients identity and data are kept confidential and will only be allowed to access by the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Strain Probiotics in people with Ulcerative Colitis, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norfilza M Mokhtar, MD, MMedSci, PhD (+60391458610, norfilza@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome analysis (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.