Constipation - Functional
Conditions
Keywords
Constipation, Quality of Life, Probiotic, PAC-QOL
Brief summary
This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.
Interventions
Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.
DRUGPlacebo
Fermented milk containing placebo to be consumed once daily for three weeks.
Sponsors
United States Agency for International Development (USAID)
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed