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

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

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

Conditions
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Constipation - Functional

Intervention / Treatment
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* Drug: Lactobacillus plantarum IS-10506
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Lactobacillus plantarum IS-10506 | Drug: Lactobacillus plantarum IS-10506<br>* Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Fermented milk containing placebo to be consumed once daily for three weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Quality of Life, Probiotic, PAC-QOL