Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Phase 2

Completed

• Conditions: Constipation - Functional
• Interventions: Drug: Placebo; Drug: Lactobacillus plantarum

• Registration Number: NCT03885973
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-28
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2019-03
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-21
• Study First Posted: 2019-03-22
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks.
Lactobacillus plantarum	Lactobacillus plantarum	1 bottle of fermented milk (100 g) containing probiotic Lactobacillus plantarum IS-10506 1.0x10\^8 CFU will be given daily for three weeks.

Primary Outcome Measures

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

Puskesmas Petamburan; 🇮🇩 Jakarta, DKI Jakarta, Indonesia