Constipation - Functional
Conditions
Keywords
SCFA, Probiotic, Lactobacillus plantarum, Functional constipation
Brief summary
In this study, the investigators measured the SCFA (Butyrate, Acetate and Propionate) as a Biomarker improvement symptom and quality of life women with functional constipation after supplementation of commensal bacterial fermented milk Lactobacillus plantarum (isolated from indigenous probiotics from Dadih, West Sumatra) for 21 days
Interventions
Fermented milk containing probiotic Lactobacillus plantarum for three weeks
DRUGPlacebo
Fermented milk containing placebo for three weeks
Sponsors
United States Agency for International Development (USAID)
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Chain Fatty Acid (SCFA) titer | Three weeks after intervention | Short Chain Fatty Acid (SCFA) titer that will be analyzed by Gas chromatography-mass spectrometry (GCMS) consists of three metabolites: * Butyrate will be shown in mM unit measure, higher value represents better outcome * Acetate will be shown in mM unit measure, higher value represents better outcome * Proprionate will be shown in mM unit measure, higher value represents better outcome |
| Functional constipation symptom improvement (1) | Three weeks after intervention | Functional constipation symptom improvement (1) will be measured by improvement of PAC Sym questionnaire score. PAC Sym (Patient Assessment of Constipation Symptoms) has a minimum score of 0, maximum score 48, lower value represents better outcome |
| Functional constipation symptom improvement (2) | Three weeks after intervention | Functional constipation symptom improvement (2) will be measured by improvement of PAC QoL questionnaire score. PAC QoL (Patient Assessment of Constipation Quality of Life) has a minimum score of -20, maximum score 92, lower value represents better outcome |
| Molecular Profile of Fecal Microbiome | Three weeks after intervention | Microbiome profile from faecal samples will be analyzed with NGS (Next Gen Sequencing) method. The result will be analyzed with MiSEq Reporter software (MSR) and will be presented in nM unit measure. |
Countries
Indonesia
Outcome results
None listed