Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Fakultas Kedokteran Universitas Indonesia76 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Constipation - Functional

Interventions

Lactobacillus plantarumDRUG

Fermented milk containing probiotic Lactobacillus plantarum for three weeks

PlaceboDRUG

Fermented milk containing placebo for three weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Puskesmas Petamburan

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Short Chain Fatty Acid (SCFA) titer

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

Time frame: Three weeks after intervention

Functional constipation symptom improvement (1)

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

Time frame: Three weeks after intervention

Functional constipation symptom improvement (2)

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

Time frame: Three weeks after intervention

Molecular Profile of Fecal Microbiome

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.

Time frame: Three weeks after intervention

Data from ClinicalTrials.gov

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