Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-28

Study Completion Date

2018-08-22

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

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Detailed Description

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Conditions

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Constipation - Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lactobacillus plantarum

1 bottle of fermented milk (100 g) containing probiotic Lactobacillus plantarum IS-10506 1.0x10\^8 CFU will be given daily for three weeks.

Group Type EXPERIMENTAL

Lactobacillus plantarum

Intervention Type DRUG

Fermented milk containing probiotic Lactobacillus plantarum for three weeks

Placebo

1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Fermented milk containing placebo for three weeks

Interventions

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Lactobacillus plantarum

Fermented milk containing probiotic Lactobacillus plantarum for three weeks

Intervention Type DRUG

Placebo

Fermented milk containing placebo for three weeks

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No