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

February 3, 2019 updated by: Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia

The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Fermented milk containing placebo to be consumed once daily for three weeks.
Experimental: Probiotic
Lactobacillus plantarum IS-10506
Drug: Lactobacillus plantarum IS-10506
Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in quality of life
Time Frame: Three weeks after intervention.

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
Three weeks after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakultas Kedokteran Universitas Indonesia

Collaborators

United States Agency for International Development (USAID)

Investigators

  • Principal Investigator: Hasan Maulahela, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2018

Primary Completion (Actual)

July 21, 2018

Study Completion (Actual)

July 21, 2018

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 3, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART CITY #AID-497-A-1600004
  • Sub Grant #IIE-00000078-UI-1 (Other Grant/Funding Number: USAID/SHERA - SMART CITY)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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