Constipation - FunctionalPhase 2NCT06122558
Efficacy of Probiotic Against Functional Constipation
A Phase 2 study testing Probiotic in people with Constipation - Functional, run by Min-Tze LIONG at 2 sites in 2 countries.
Trial summary
This project aims to study the benefits of probiotic in modulating gut microbiota and treating functional constipation in patients aged 18-81. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Oct 2023to 26 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnostic criteria for functional constipation in the Rome IV
- Ruled out for IBS or secondary constipation
Who cannot join
- Diagnosed with refractory constipation
- Any other constipation caused by neurological diseases, metabolic diseases, obstructive diseases and drugs
- Mental illness
- Immunodeficiency diseases or used immunosuppressants, serious diseases of the heart, brain, kidney and other systems, malignant tumors, intestinal perforation, intestinal obstruction, intestinal bleeding
- Currently using antibiotics or have a history of taking antibiotics in the past 4 weeks.
- Participating in other clinical trials
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Deyang People's Hospital
Deyang, Sichuan
Fan Zheng, MD, +86 135 1826 1820, fan7jzg@foxmail.com
Yong Yang, MD, +86 187 8388 1797, yongyz88@126.com
Malaysia1 site, 1 recruiting
- Not yet recruiting
School of Industrial Technology, Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, 11900
Min Tze Liong, PhD, 6046532114, mintze.liong@usm.my
About this study
Official title: Efficacy of Probiotic in Patients With Functional Constipation
This project aims to study the benefits of probiotic in modulating gut microbiota and treating functional constipation in patients aged 18-81.
Read the detailed description
Constipation is a common clinical intestinal functional disease worldwide, and its main manifestations are difficulty in defecation and/or decreased frequency of defecation. Difficulty defecating includes straining, difficulty passing, sensation of incomplete defecation, sensation of anorectal blockage, time-consuming defecation, and need for assistance, fewer bowel movements are fewer than 3 bowel movements per week and the duration of chronic constipation is at least 6 months.
The quality of life of patients with chronic constipation is significantly lower than that of non-chronic constipation patients. Some patients have a heavy financial burden due to abuse of laxatives or repeated visits to doctors, including visits to doctors, examinations, direct economic losses caused by treatment and hospitalization and indirect economic losses caused by reduced work productivity and absenteeism.
Constipation caused by functional diseases is mainly caused by nerve smooth muscle dysfunction in the colon, rectum and anus, including functional constipation, functional defecation disorder and constipation-predominant irritable bowel syndrome. In some cases, functional constipation may be related to normal or slow colonic transit and/or bowel dysfunction (pelvic floor dysfunction).
Constipation treatment methods include basic treatment measures such as increasing dietary fiber and water, increasing exercise and other lifestyles, and establishing good bowel habits. Volumetric laxatives and osmotic laxatives are options for patients with mild to moderate constipation. Stimulant laxatives may be used as a short-term/intermittent remedy.
In recent years, the treatment of chronic constipation patients with probiotics has been proposed. Existing research data confirm that patients with chronic constipation have intestinal microecological imbalance. Studies have shown that Bifidobacterium, Lactobacillus, dominant bacterial groups such as Bacteroides decreased significantly, while Escherichia coli, Staphylococcus aureus, Enterobacteriaceae (Citrobacter, Klebsiella, etc.) and fungi and other potential pathogenic bacteria increased significantly, and this trend was related to the severity of constipation. Although probiotics are not the first-line drugs for the treatment of chronic constipation, they can promote intestinal peristalsis and restoration of gastrointestinal motility. Possible mechanisms include changes in the number and types of intestinal flora; metabolites of the flora (methane and short-chain fatty acids), cellular components of bacteria (lipopolysaccharides) or the interaction between bacteria and the host immune system affects a variety of gut functions. Gut microbes through the digestion of polysaccharides in the gut produce short chain fatty acids (short chain fatty acids, SCFAs) to provide energy for the body. SCFAs produced by intestinal flora metabolism also inhibits the growth of pathogenic bacteria and reduces the accumulation of phenolic substances produced by pathogenic bacteria, promote intestinal peristalsis to relieve constipation symptoms.
- Conditions
- Constipation - Functional
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks
PlaceboDietary supplement
Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota profiles of fecal samples in patients with functional constipation upon administration of probiotic or placebo
Differences in microbiota abundance in fecal sample of patients with functional constipation upon administration of probiotic compared to placebo as assessed via DNA profiling of fecal samples upon Ilumina MiSeq sequencing
Measured: 8-weeks
Secondary outcomes (5)
Constipation profiles of patients with functional constipation upon administration of probiotic or placebo
Differences in constipation profiles in patients with functional constipation upon administration of probiotic compared to placebo as assessed via number of complete spontaneous bowel movement (CSBM) per week and bowel habits
Measured: 8-weeks
Quality of life profiles of patients with functional constipation upon administration of probiotic or placebo
Differences in QoL profiles in patients with functional constipation upon administration of probiotic compared to placebo as assessed via the Hamilton Anxiety Scale (HAM-A) comprising of 14-items, with a 5-point Likert scale (8-56 points), where a higher score indicates more severe anxiety symptoms
Measured: 8-weeks
Defecation profiles of patients with functional constipation upon administration of probiotic or placebo
Differences in defecation profiles in patients with functional constipation upon administration of probiotic compared to placebo as assessed via the balloon expulsion test (time to expel the balloon)
Measured: 8-weeks
Defecation profiles of patients with functional constipation upon administration of probiotic or placebo
Differences in defecation profiles in patients with functional constipation upon administration of probiotic compared to placebo as assessed via pelvic floor muscle electromyography
Measured: 8-weeks
Immunity profiles of patients with functional constipation upon administration of probiotic as assessed via blood samples
Differences in concentrations of proteins such as interleukins (IL-10, IL-4, IL-6, Tumour Necrosis Factor-alpha, Interferon gamma) in blood samples of patients upon administration of probiotic compared to placebo
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start27 Oct 2023
- Primary completion26 Oct 2025 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- Deyang People's Hospital
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Min Liong, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122558
- Sponsor's protocol ID
- DCPH-2023-03-001-K01
- Other IDs
- P-ID0024/21(R)
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotic in Patients With Functional Constipation
- ClinicalTrials.gov ID
- NCT06122558
- Acronym / sponsor ID
- DCPH-2023-03-001-K01
- Conditions
- Constipation - Functional
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- Deyang People's Hospital
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 26 Oct 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 8 Nov 2023 (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.
This project aims to study the benefits of probiotic in modulating gut microbiota and treating functional constipation in patients aged 18-81.
Detailed description
Constipation is a common clinical intestinal functional disease worldwide, and its main manifestations are difficulty in defecation and/or decreased frequency of defecation. Difficulty defecating includes straining, difficulty passing, sensation of incomplete defecation, sensation of anorectal blockage, time-consuming defecation, and need for assistance, fewer bowel movements are fewer than 3 bowel movements per week and the duration of chronic constipation is at least 6 months.
The quality of life of patients with chronic constipation is significantly lower than that of non-chronic constipation patients. Some patients have a heavy financial burden due to abuse of laxatives or repeated visits to doctors, including visits to doctors, examinations, direct economic losses caused by treatment and hospitalization and indirect economic losses caused by reduced work productivity and absenteeism.
Constipation caused by functional diseases is mainly caused by nerve smooth muscle dysfunction in the colon, rectum and anus, including functional constipation, functional defecation disorder and constipation-predominant irritable bowel syndrome. In some cases, functional constipation may be related to normal or slow colonic transit and/or bowel dysfunction (pelvic floor dysfunction).
Constipation treatment methods include basic treatment measures such as increasing dietary fiber and water, increasing exercise and other lifestyles, and establishing good bowel habits. Volumetric laxatives and osmotic laxatives are options for patients with mild to moderate constipation. Stimulant laxatives may be used as a short-term/intermittent remedy.
In recent years, the treatment of chronic constipation patients with probiotics has been proposed. Existing research data confirm that patients with chronic constipation have intestinal microecological imbalance. Studies have shown that Bifidobacterium, Lactobacillus, dominant bacterial groups such as Bacteroides decreased significantly, while Escherichia coli, Staphylococcus aureus, Enterobacteriaceae (Citrobacter, Klebsiella, etc.) and fungi and other potential pathogenic bacteria increased significantly, and this trend was related to the severity of constipation. Although probiotics are not the first-line drugs for the treatment of chronic constipation, they can promote intestinal peristalsis and restoration of gastrointestinal motility. Possible mechanisms include changes in the number and types of intestinal flora; metabolites of the flora (methane and short-chain fatty acids), cellular components of bacteria (lipopolysaccharides) or the interaction between bacteria and the host immune system affects a variety of gut functions. Gut microbes through the digestion of polysaccharides in the gut produce short chain fatty acids (short chain fatty acids, SCFAs) to provide energy for the body. SCFAs produced by intestinal flora metabolism also inhibits the growth of pathogenic bacteria and reduces the accumulation of phenolic substances produced by pathogenic bacteria, promote intestinal peristalsis to relieve constipation symptoms.
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 |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticProbiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meet the diagnostic criteria for functional constipation in the Rome IV
- Ruled out for IBS or secondary constipation
Key exclusion criteria (6 listed)
- Diagnosed with refractory constipation
- Any other constipation caused by neurological diseases, metabolic diseases, obstructive diseases and drugs
- Mental illness
- Immunodeficiency diseases or used immunosuppressants, serious diseases of the heart, brain, kidney and other systems, malignant tumors, intestinal perforation, intestinal obstruction, intestinal bleeding
- Currently using antibiotics or have a history of taking antibiotics in the past 4 weeks.
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 |
|---|---|---|
| ProbioticProbiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks | Dietary supplement | Probiotic |
| PlaceboIntervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks) | Dietary supplement | Placebo |
Primary outcome
Microbiota profiles of fecal samples in patients with functional constipation upon administration of probiotic or placebo
Time frame: 8-weeks
Differences in microbiota abundance in fecal sample of patients with functional constipation upon administration of probiotic compared to placebo as assessed via DNA profiling of fecal samples upon Ilumina MiSeq sequencing
5 secondary outcomes
Constipation profiles of patients with functional constipation upon administration of probiotic or placebo
Time frame: 8-weeks
Quality of life profiles of patients with functional constipation upon administration of probiotic or placebo
Time frame: 8-weeks
Defecation profiles of patients with functional constipation upon administration of probiotic or placebo
Time frame: 8-weeks
Defecation profiles of patients with functional constipation upon administration of probiotic or placebo
Time frame: 8-weeks
Immunity profiles of patients with functional constipation upon administration of probiotic as assessed via blood samples
Time frame: 8-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Min Liong, PhD principal investigator
Universiti Sains Malaysia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Constipation - Functional, run by Min-Tze LIONG at 2 sites in 2 countries.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Tze Liong, PhD (046532114, mintze.liong@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota profiles of fecal samples in patients with functional constipation upon administration of probiotic or placebo (time frame: 8-weeks). 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 8 Nov 2023.