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

Phase 2

Completed

• Conditions: Constipation - Functional
• Interventions: Drug: Lactobacillus plantarum IS-10506; Drug: Placebo

• Registration Number: NCT03829358
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-24
• Primary Completion: 2018-07-21
• Study Completion: 2018-07-21
• Status Verified: 2019-02
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-03
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Lactobacillus plantarum IS-10506	Lactobacillus plantarum IS-10506
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life	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

Trial Locations

Locations (1)

Puskesmas Petamburan; 🇮🇩 Jakarta, DKI Jakarta, Indonesia