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The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation

Primary Purpose

Constipation - Functional

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Lactobacillus plantarum IS-10506
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional focused on measuring Constipation, Quality of Life, Probiotic, PAC-QOL

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

Probiotic

Placebo

Arm Description

Lactobacillus plantarum IS-10506

Placebo

Outcomes

Primary Outcome Measures

Improvement in quality of life
Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction. Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction • Total score, minimum score -20, maximum score 92, lower value represents better outcome

Secondary Outcome Measures

Full Information

First Posted
February 1, 2019
Last Updated
February 3, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
Collaborators
United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03829358
Brief Title
The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation
Official Title
The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 24, 2018 (Actual)
Primary Completion Date
July 21, 2018 (Actual)
Study Completion Date
July 21, 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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional
Keywords
Constipation, Quality of Life, Probiotic, PAC-QOL

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
Probiotic
Arm Type
Experimental
Arm Description
Lactobacillus plantarum IS-10506
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Lactobacillus plantarum IS-10506
Intervention Description
Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Fermented milk containing placebo to be consumed once daily for three weeks.
Primary Outcome Measure Information:
Title
Improvement in quality of life
Description
Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction. Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction • Total score, minimum score -20, maximum score 92, lower value represents better outcome
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
No
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
Hasan Maulahela, MD
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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The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation

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