Probiotics in Women With Primary Dysmenorrhoea

National University of Malaysia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Dysmenorrhea

Treatments: Biological: Probiotic; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04119011

FF-2018-204

Details and patient eligibility

About

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

Full description

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

Enrollment: 72 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Biological: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo