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

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: Constipation - Functional
• Intervention / Treatment: Drug: Lactobacillus plantarum IS-10506; 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 Assignment
• Masking: Double

Number of Arms

2

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	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

• 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

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: Constipation; Quality of Life; Probiotic; PAC-QOL
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• 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