Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Study Overview
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Brief Summary
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In this study, the investigators measured the SCFA (Butyrate, Acetate and Propionate) as a Biomarker improvement symptom and quality of life women with functional constipation after supplementation of commensal bacterial fermented milk Lactobacillus plantarum (isolated from indigenous probiotics from Dadih, West Sumatra) for 21 days

Official Title
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Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation: Molecular Profile of Fecal Microbiome With NGS Method

Conditions
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Constipation - Functional

Intervention / Treatment
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* Drug: Lactobacillus plantarum
* 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: Lactobacillus plantarum<br>1 bottle of fermented milk (100 g) containing probiotic Lactobacillus plantarum IS-10506 1.0x10^8 CFU will be given daily for three weeks. | Drug: Lactobacillus plantarum<br>* Fermented milk containing probiotic Lactobacillus plantarum for three weeks<br>|
| Placebo Comparator: Placebo<br>1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks. | Drug: Placebo<br>* Fermented milk containing placebo for three weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Chain Fatty Acid (SCFA) titer | Short Chain Fatty Acid (SCFA) titer that will be analyzed by Gas chromatography-mass spectrometry (GCMS) consists of three metabolites: Butyrate will be shown in mM unit measure, higher value represents better outcome Acetate will be shown in mM unit measure, higher value represents better outcome Proprionate will be shown in mM unit measure, higher value represents better outcome | Three weeks after intervention | 
| Functional constipation symptom improvement (1) | Functional constipation symptom improvement (1) will be measured by improvement of PAC Sym questionnaire score. PAC Sym (Patient Assessment of Constipation Symptoms) has a minimum score of 0, maximum score 48, lower value represents better outcome | Three weeks after intervention | 
| Functional constipation symptom improvement (2) | Functional constipation symptom improvement (2) will be measured by improvement of PAC QoL questionnaire score. PAC QoL (Patient Assessment of Constipation Quality of Life) has a minimum score of -20, maximum score 92, lower value represents better outcome | Three weeks after intervention | 
| Molecular Profile of Fecal Microbiome | Microbiome profile from faecal samples will be analyzed with NGS (Next Gen Sequencing) method. The result will be analyzed with MiSEq Reporter software (MSR) and will be presented in nM unit measure. | Three weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCFA, Probiotic, Lactobacillus plantarum, Functional constipation