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Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Primary Purpose

Constipation - Functional

Status

Completed

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

Lactobacillus plantarum

Placebo

About this trial

This is an interventional treatment trial for Constipation - Functional focused on measuring SCFA, Probiotic, Lactobacillus plantarum, Functional constipation

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Puskesmas Petamburan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus plantarum

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03885973

First Posted

March 17, 2019

Last Updated

March 21, 2019

Sponsor

Fakultas Kedokteran Universitas Indonesia

Collaborators

United States Agency for International Development (USAID)

1. Study Identification

Unique Protocol Identification Number

NCT03885973

Brief Title

Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

July 28, 2018 (Actual)

Primary Completion Date

August 22, 2018 (Actual)

Study Completion Date

August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fakultas Kedokteran Universitas Indonesia

Collaborators

United States Agency for International Development (USAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation - Functional

Keywords

SCFA, Probiotic, Lactobacillus plantarum, Functional constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lactobacillus plantarum

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lactobacillus plantarum

Intervention Description

Fermented milk containing probiotic Lactobacillus plantarum for three weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Fermented milk containing placebo for three weeks

Primary Outcome Measure Information:

Title

Short Chain Fatty Acid (SCFA) titer

Description

Time Frame

Three weeks after intervention

Title

Functional constipation symptom improvement (1)

Description

Time Frame

Three weeks after intervention

Title

Functional constipation symptom improvement (2)

Description

Time Frame

Three weeks after intervention

Title

Molecular Profile of Fecal Microbiome

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pratiwi D Kusumo

Organizational Affiliation

Fakultas Kedokteran Universitas Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Puskesmas Petamburan

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

11440

Country

Indonesia

12. IPD Sharing Statement

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Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

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