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

NCT03829358 | Completed Phase 2

• 2 other identifiers: SMART CITY #AID-497-A-1600004Sub Grant #IIE-00000078-UI-1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation - Functional

Keywords

Constipation; Quality of Life; Probiotic; PAC-QOL

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus plantarum IS-10506

Drug: Lactobacillus plantarum IS-10506

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lactobacillus plantarum IS-10506 DRUG

Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.

Probiotic

Placebo DRUG

Fermented milk containing placebo to be consumed once daily for three weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Puskesmas Petamburan

Jakarta, DKI Jakarta, 11440, Indonesia

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hasan Maulahela, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: February 24, 2018
• Primary Completion: July 21, 2018
• Study Completion: July 21, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

ID (1)