Probiotics in Women With Primary Dysmenorrhoea

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

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-03-31

Brief Summary

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This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea

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Detailed Description

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This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea

Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized placebo-controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

placebo and probiotic are labelled A or B, this is prepared by the manufacturer and blinded from the participant and investigator, the unblinding takes place only after completion of the data collection

Study Groups

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Probiotic

Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months

Group Type EXPERIMENTAL

Probiotic

Intervention Type BIOLOGICAL

(Lactobacillus acidophilus, lactobacillus casei, lactobacillus lactis) and Bifidobacterium (Bifidobacterium bifidum, bifidobacterium longum, bifidobacterium infantis) lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor

Placebo

Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor

Interventions

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Probiotic

(Lactobacillus acidophilus, lactobacillus casei, lactobacillus lactis) and Bifidobacterium (Bifidobacterium bifidum, bifidobacterium longum, bifidobacterium infantis) lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor

Intervention Type BIOLOGICAL

Placebo

lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* regular menstrual cycles between 21 to 45 days
* primary dysmenorrhoea only
* willing to consume sachets twice daily for 3 months

Exclusion Criteria

* current Intrauterine Copper Device (IUCD) user
* recent hormonal (estrogen or progesterone) therapy in last 3 months
* on treatment for allergy such as antihistamine
* diarrhoea with dairy product
* often take drugs which may affect the test results (such as medicines treating constipation or digestive medicine such as laxatives or enema)
* any malignant tumor regardless of type or site

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes