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

Constipation - Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829358
• Other study ID #: SMART CITY #AID-497-A-1600004
• Secondary ID: Sub Grant #IIE-0
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 24, 2018
• Est. completion date: July 21, 2018

Study information

• Verified date: February 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 21, 2018
• Est. primary completion date: July 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Drug:
• Lactobacillus plantarum IS-10506
Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.
• Placebo
Fermented milk containing placebo to be consumed once daily for three weeks.

Locations

Country	Name	City	State
Indonesia	Puskesmas Petamburan	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.