Probiotics in Women With Primary Dysmenorrhoea

NCT04119011 | Completed Phase 1

• 1 other identifier: FF-2018-204
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Dysmenorrhea

Keywords

probiotics

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• severity score before treatment (verbal rating score)

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

  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

  after 3 months of treatment

• 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

• 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

• 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 Outcomes (3)

• Concentration of inflammatory markers pre-treatment

  baseline

• Concentration of inflammatory markers post-treatment

  At 3 months after commencement of treatment

• intestinal microbiota before and after treatment with probiotics

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

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Biological: Probiotic

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Probiotic

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead
• B-Crobes Marketing(M) Sdn Bhd: collaborator

Study Sites (1)

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

• Zakaria IA, Mohammed Zain NA, Teik CK, Abu MA, Zainuddin AA, Abdul Aziz NH, Safian N, Mohd Mokhtar N, Raja Ali RA, Beng Kwang N, Mohamed Ismail NA, Hamizan MR, Ab Razak WS, Nur Azurah AG. The role of probiotics in improving menstrual health in women with primary dysmenorrhoea: A randomized, double-blind, placebo-controlled trial (the PERIOD study). Womens Health (Lond). 2024 Jan-Dec;20:17455057241234524. doi: 10.1177/17455057241234524.

  PMID: 38444064 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nur Azurah Abd Ghani

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized placebo-controlled trial

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 8, 2019
• Study Start: October 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 20 months

Locations

MY (1)