NCT03885973

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

25 days

First QC Date

March 17, 2019

Last Update Submit

March 21, 2019

Conditions

Constipation - Functional

Keywords

SCFAProbioticLactobacillus plantarumFunctional constipation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Lactobacillus plantarum

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks.

Drug: Placebo

Interventions

Lactobacillus plantarumDRUG

Fermented milk containing probiotic Lactobacillus plantarum for three weeks

Lactobacillus plantarum
PlaceboDRUG

Fermented milk containing placebo for three weeks

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puskesmas Petamburan

Jakarta, DKI Jakarta, 11440, Indonesia

Location

Study Officials

  • Pratiwi D Kusumo

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 22, 2019

Study Start

July 28, 2018

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

ID(1)