- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06122558
Efficacy of Probiotic Against Functional Constipation
Efficacy of Probiotic in Patients With Functional Constipation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Min Tze Liong, PhD
- Phone Number: 046532114
- Email: mintze.liong@usm.my
Study Locations
-
-
Sichuan
-
Deyang, Sichuan, China
- Recruiting
- Deyang People's Hospital
-
Contact:
- Fan Zheng, MD
- Phone Number: +86 135 1826 1820
- Email: fan7jzg@foxmail.com
-
Contact:
- Yong Yang, MD
- Phone Number: +86 187 8388 1797
- Email: yongyz88@126.com
-
-
-
-
Penang
-
Pulau Pinang, Penang, Malaysia, 11900
- Not yet recruiting
- School of Industrial Technology, Universiti Sains Malaysia
-
Contact:
- Min Tze Liong, PhD
- Phone Number: 6046532114
- Email: mintze.liong@usm.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meet the diagnostic criteria for functional constipation in the Rome IV
- Ruled out for IBS or secondary constipation
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic
Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks
|
Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks
|
Placebo Comparator: Placebo
Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)
|
Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constipation profiles of patients with functional constipation upon administration of probiotic or placebo
Time Frame: 8-weeks
|
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
|
8-weeks
|
Quality of life profiles of patients with functional constipation upon administration of probiotic or placebo
Time Frame: 8-weeks
|
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
|
8-weeks
|
Defecation profiles of patients with functional constipation upon administration of probiotic or placebo
Time Frame: 8-weeks
|
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)
|
8-weeks
|
Defecation profiles of patients with functional constipation upon administration of probiotic or placebo
Time Frame: 8-weeks
|
Differences in defecation profiles in patients with functional constipation upon administration of probiotic compared to placebo as assessed via pelvic floor muscle electromyography
|
8-weeks
|
Immunity profiles of patients with functional constipation upon administration of probiotic as assessed via blood samples
Time Frame: 8-weeks
|
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
|
8-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Min Liong, PhD, Universiti Sains Malaysia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCPH-2023-03-001-K01
- P-ID0024/21(R) (Other Identifier: Universiti Sains Malaysia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation - Functional
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
Huazhong University of Science and TechnologyWuhan Union Hospital, China; Guangzhou University of Traditional Chinese Medicine and other collaboratorsUnknownFunctional Constipation | Functional DiarrheaChina
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
Chulalongkorn UniversityNot yet recruitingFunctional ConstipationThailand
-
AbbVieIronwood Pharmaceuticals, Inc.RecruitingFunctional ConstipationUnited States, Bulgaria, United Kingdom, Croatia, Germany, Hungary
-
Gelesis, Inc.Not yet recruitingConstipation - Functional
-
Wageningen University and ResearchAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); FrieslandCampina... and other collaboratorsRecruitingFunctional ConstipationNetherlands
-
University of AlexandriaCompletedFunctional ConstipationEgypt
-
The First Affiliated Hospital of Xiamen UniversityEnrolling by invitationFunctional ConstipationChina
-
Société des Produits Nestlé (SPN)CompletedConstipation - FunctionalIreland
Clinical Trials on Probiotic
-
King's College Hospital NHS TrustCompleted
-
Fudan UniversityInner Mongolia Yili Industrial Group Co., LtdCompletedObesity | AdiposityChina
-
Centros de Investigación de Nutrición y SaludNutribioticaCompletedFunctional ConstipationSpain
-
Universiti Kebangsaan Malaysia Medical CentreUnknownHypertension | Obesity | Type 2 Diabetes Mellitus | HyperlipidemiaMalaysia
-
Maastricht University Medical CenterCompleted
-
Fundació Sant Joan de DéuCompleted
-
University of LeedsUnknown
-
Centro Pediatrico Albina de PatinoCompletedAcute Gastroenteritis | Acute DiarrheaBolivia
-
BiocodexCompletedAcute GastroenteritisArgentina
-
Shandong UniversityUnknownGastrointestinal Neoplasms | Colorectal Cancer | Malnutrition | Effects of Chemotherapy | Tumor ImmunityChina