Probiotics in Women With Primary Dysmenorrhoea

Primary Dysmenorrhea Clinical Trial

Official title:

A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119011
• Other study ID #: FF-2018-204
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2021
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Biological:
• 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

Other:
• Placebo
lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor

Locations

Country	Name	City	State
Malaysia	National University of Malaysia	Cheras	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
National University of Malaysia	B-Crobes Marketing(M) Sdn Bhd

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score before treatment (visual analog scale VAS)	mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline	baseline
Primary	pain score after treatment (visual analog scale VAS)	mean Visual Analog Score on scale 0 to 10, on day 2 of menses after 3 months of treatment with probiotic/placebo	after 3 months of treatment
Primary	severity score before treatment (verbal rating score)	mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline	baseline
Primary	severity score after treatment (verbal rating score)	mean Verbal Rating Score on scale 0 to 3, on day 2 of menses after 3 months of treatment with placebo/probiotic	after 3 months of treatment
Primary	Quality of life before treatment (Physical and mental health score assessed by SF12v2 questionnaire)	mean quality of life score using validated health survey questionnaire Short Form 12 version 2 (SF12v2) (permission obtained from primary author) Answers from each question will be calculated using formula into percentage of average physical health score and average mental health score, on scale 0 to 100 in which higher percentage represents higher quality of life, and score less than 50 represents poor quality of life	baseline
Primary	Quality of life after treatment (physical and mental health score assessed by SF12v2 questionnaire)	mean quality of life score using validated health survey questionnaire Short Form 12 version 2 (SF12v2) (permission obtained from primary author) Answers from each question will be calculated using formula into percentage of average physical health score and average mental health score, on scale 0 to 100 in which higher percentage represents higher quality of life, and score less than 50 represents poor quality of life	at 3 months after completed treatment with probiotic or placebo
Primary	Frequency of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use between placebo and probiotic group	mean number of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use per cycle	3 months during treatment with probiotic or placebo
Secondary	Concentration of inflammatory markers pre-treatment	mean concentration of serum pro-inflammatory markers on day 2 of menses (Interleukin-1,2,4,5,6,7,8,10,12p70,13,17, Tumour necrosis factor-alpha, Granulocyte Colony Stimulating Factor, and Regulated on activation normal T-cell expressed and secreted) all in pg/mL, reported individually in table form	baseline
Secondary	Concentration of inflammatory markers post-treatment	mean concentration of serum pro-inflammatory markers on day 2 of menses (Interleukin-1,2,4,5,6,7,8,10,12p70,13,17, Tumour necrosis factor-alpha, Granulocyte Colony Stimulating Factor, and Regulated on activation normal T-cell expressed and secreted) all in pg/mL, reported individually in table form	At 3 months after commencement of treatment
Secondary	intestinal microbiota before and after treatment with probiotics	Relative abundance of microbiome DNA in percentage	on date of randomization and at 3 month after completed treatment with probiotic or placebo