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Completed

NCT Number: NCT04119011

Probiotics in Women With Primary Dysmenorrhoea

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

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Key information

Conditions

Primary Dysmenorrhea

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

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

Other

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

Primary outcomes

  1. pain score before treatment (visual analog scale VAS)

    Time frame: baseline

    mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline

  2. pain score after treatment (visual analog scale VAS)

    Time frame: after 3 months of treatment

    mean Visual Analog Score on scale 0 to 10, on day 2 of menses after 3 months of treatment with probiotic/placebo

  3. severity score before treatment (verbal rating score)

    Time frame: baseline

    mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline

  4. severity score after treatment (verbal rating score)

    Time frame: after 3 months of treatment

    mean Verbal Rating Score on scale 0 to 3, on day 2 of menses after 3 months of treatment with placebo/probiotic

  5. Quality of life before treatment (Physical and mental health score assessed by SF12v2 questionnaire)

    Time frame: baseline

    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

  6. Quality of life after treatment (physical and mental health score assessed by SF12v2 questionnaire)

    Time frame: at 3 months after completed treatment with probiotic or placebo

    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

  7. Frequency of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use between placebo and probiotic group

    Time frame: 3 months during treatment with probiotic or placebo

    mean number of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use per cycle

Secondary outcomes

  1. Concentration of inflammatory markers pre-treatment

    Time frame: baseline

    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

  2. Concentration of inflammatory markers post-treatment

    Time frame: At 3 months after commencement of 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

  3. intestinal microbiota before and after treatment with probiotics

    Time frame: on date of randomization and at 3 month after completed treatment with probiotic or placebo

    Relative abundance of microbiome DNA in percentage

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Collaborators

  • B-Crobes Marketing(M) Sdn Bhd

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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