Probiotics in Women With Primary Dysmenorrhoea
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring probiotics
Eligibility Criteria
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
Sites / Locations
- National University of Malaysia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months
Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months
Outcomes
Primary Outcome Measures
pain score before treatment (visual analog scale VAS)
mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline
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
severity score before treatment (verbal rating score)
mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline
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
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
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
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
Secondary Outcome Measures
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
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
intestinal microbiota before and after treatment with probiotics
Relative abundance of microbiome DNA in percentage
Full Information
NCT ID
NCT04119011
First Posted
September 30, 2019
Last Updated
February 19, 2021
Sponsor
National University of Malaysia
Collaborators
B-Crobes Marketing(M) Sdn Bhd
1. Study Identification
Unique Protocol Identification Number
NCT04119011
Brief Title
Probiotics in Women With Primary Dysmenorrhoea
Official Title
A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
Collaborators
B-Crobes Marketing(M) Sdn Bhd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea
Detailed Description
This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized placebo-controlled trial
Masking
ParticipantInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months
Intervention Type
Biological
Intervention Name(s)
Probiotic
Intervention Description
(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
Other
Intervention Name(s)
Placebo
Intervention Description
lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor
Primary Outcome Measure Information:
Title
pain score before treatment (visual analog scale VAS)
Description
mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline
Time Frame
baseline
Title
pain score after treatment (visual analog scale VAS)
Description
mean Visual Analog Score on scale 0 to 10, on day 2 of menses after 3 months of treatment with probiotic/placebo
Time Frame
after 3 months of treatment
Title
severity score before treatment (verbal rating score)
Description
mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline
Time Frame
baseline
Title
severity score after treatment (verbal rating score)
Description
mean Verbal Rating Score on scale 0 to 3, on day 2 of menses after 3 months of treatment with placebo/probiotic
Time Frame
after 3 months of treatment
Title
Quality of life before treatment (Physical and mental health score assessed by SF12v2 questionnaire)
Description
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
Time Frame
baseline
Title
Quality of life after treatment (physical and mental health score assessed by SF12v2 questionnaire)
Description
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
Time Frame
at 3 months after completed treatment with probiotic or placebo
Title
Frequency of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use between placebo and probiotic group
Description
mean number of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use per cycle
Time Frame
3 months during treatment with probiotic or placebo
Secondary Outcome Measure Information:
Title
Concentration of inflammatory markers pre-treatment
Description
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
Time Frame
baseline
Title
Concentration of inflammatory markers post-treatment
Description
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
Time Frame
At 3 months after commencement of treatment
Title
intestinal microbiota before and after treatment with probiotics
Description
Relative abundance of microbiome DNA in percentage
Time Frame
on date of randomization and at 3 month after completed treatment with probiotic or placebo
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur Azurah Abd Ghani
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
clinical data sheet containing demographics, data collection (pain score, quality of life questionnaire, pain diary)
IPD Sharing Time Frame
20 months
Learn more about this trial
Probiotics in Women With Primary Dysmenorrhoea
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