- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03829358
The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation
The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 11440
- Puskesmas Petamburan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)
- Having the symptoms and signs of functional constipation refer to ROME IV
- Able to communicate well
- Able to consume 1 bottle of fermented milk each day for three weeks
- Not using antibiotic no later than one week before supplementation
Exclusion Criteria:
- Diagnosed with functional bowel disorder
- Using anesthesia at least 4 weeks before treatment
- Having a serious pathological disorder (carcinoma)
- During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
- Having severe heart disease
- Taking chronic medications such as antidepressants or analgesics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Fermented milk containing placebo to be consumed once daily for three weeks.
|
Experimental: Probiotic
Lactobacillus plantarum IS-10506
|
Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in quality of life
Time Frame: Three weeks after intervention.
|
Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction.
Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction • Total score, minimum score -20, maximum score 92, lower value represents better outcome |
Three weeks after intervention.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hasan Maulahela, MD, Fakultas Kedokteran Universitas Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMART CITY #AID-497-A-1600004
- Sub Grant #IIE-00000078-UI-1 (Other Grant/Funding Number: USAID/SHERA - SMART CITY)
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
-
Huazhong University of Science and TechnologyWuhan Union Hospital, China; Guangzhou University of Traditional Chinese Medicine and other collaboratorsUnknownFunctional Constipation | Functional DiarrheaChina
-
Pamukkale UniversityRecruiting
-
Shanghai University of Traditional Chinese MedicineLonghua Hospital; Shanghai Municipal Hospital of Traditional Chinese MedicineRecruiting
-
Universidade Nova de LisboaCINTESIS - Center for Health Technology and Services ResearchRecruiting
-
United PharmaceuticalsDelta ConsultantsRecruitingFunctional ConstipationItaly
-
King's College LondonImperial College London; Queen Mary University of LondonRecruitingConstipation - FunctionalUnited Kingdom
-
Children's Hospital Los AngelesTerminatedFunctional ConstipationUnited States
-
Pusan National University Yangsan HospitalCompletedConstipation - FunctionalKorea, Republic of
-
ortisCEN BiotechCompleted
-
Anji PharmaCovanceCompletedFunctional ConstipationChina, United States
Clinical Trials on Lactobacillus plantarum IS-10506
-
Dr. Soetomo General HospitalUniversitas AirlanggaRecruiting
-
Gadjah Mada UniversityCompletedHumoral Immune ResponseIndonesia
-
Region SkaneLund UniversityTerminatedClostridium Difficile Colonisation | Impact of Enteral Probiotics on Certain Lab ParametersSweden
-
National Taiwan University HospitalUnknownRett Syndrome | Tourette Syndrome | Tic DisordersTaiwan
-
Nanfang Hospital of Southern Medical UniversityNot yet recruitingHelicobacter Pylori Infection
-
National Taiwan Sport UniversitySYNBIO TECH INC.CompletedFrail Elderly Syndrome | SarcopeniaTaiwan
-
Region SkaneLund UniversityCompletedOropharyngeal MicrobiologySweden
-
University of CopenhagenThe Ministry of Science, Technology and Innovation, DenmarkCompleted
-
Norwegian University of Science and TechnologySykehuset Innlandet HF; Norwegian Foundation for Health and Rehabilitation; Norwegian... and other collaboratorsCompletedIrritable Bowel Syndrome | Functional Gastrointestinal DisordersNorway
-
Green Cross WellbeingRecruitingRespiratory SymptomsKorea, Republic of