Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
104 participants
INTERVENTIONAL
2023-10-27
2025-10-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy of a Probiotic for Functional Constipation (FC)
NCT06083311
Probiotics Alleviate Functional Constipation in Adults
NCT06879587
Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation
NCT04667884
Probiotics for Alleviating Functional Constipation in Adults
NCT06637397
An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation
NCT02418507
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Probiotic
Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks
Probiotic
Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks
Placebo
Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)
Placebo
Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probiotic
Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks
Placebo
Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ruled out for IBS or secondary constipation
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Deyang People's Hospital
OTHER
Min-Tze LIONG
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Min-Tze LIONG
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Min Liong, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Sains Malaysia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deyang People's Hospital
Deyang, Sichuan, China
School of Industrial Technology, Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P-ID0024/21(R)
Identifier Type: OTHER
Identifier Source: secondary_id
DCPH-2023-03-001-K01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.