Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation: Molecular Profile of Fecal Microbiome With NGS Method

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 Overview

• Status: Completed
• Conditions: Constipation - Functional
• Intervention / Treatment: Drug: Lactobacillus plantarum; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 11440
      • Puskesmas Petamburan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lactobacillus plantarum; Fermented milk containing probiotic Lactobacillus plantarum for three weeks
Placebo Comparator: Placebo; 1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks.	Drug: Placebo; Fermented milk containing placebo for three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	Three weeks after intervention

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Collaborators: United States Agency for International Development (USAID)
• Investigators: Principal Investigator: Pratiwi D Kusumo, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2018
• Primary Completion (Actual): August 22, 2018
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: March 17, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Probiotic; Lactobacillus plantarum; Functional constipation; SCFA
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 18-01-0060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No