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

University of Indonesia (UI)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Constipation - Functional

Treatments: Drug: Lactobacillus plantarum IS-10506; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03829358

SMART CITY #AID-497-A-1600004

Sub Grant #IIE-00000078-UI-1 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Lactobacillus plantarum IS-10506

Treatment:

Drug: Lactobacillus plantarum IS-10506

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo