Primary DysmenorrheaPhase 1/2NCT04119011
Probiotics in Women With Primary Dysmenorrhoea
A Phase 1/2 study testing Probiotic in people with Primary Dysmenorrhea, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2019to 31 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- regular menstrual cycles between 21 to 45 days
- primary dysmenorrhoea only
- willing to consume sachets twice daily for 3 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial
This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea
Read the detailed description
This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea
- Conditions
- Primary Dysmenorrhea
- Being tested
- Probiotic, Placebo
- Keywords
- probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticBiological
(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
PlaceboOther
lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months Receives: Biological: Probiotic |
| Placebo | Placebo comparator | Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score before treatment (visual analog scale VAS)
mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months during treatment with probiotic or placebo
Secondary outcomes (3)
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
Measured: baseline
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
Measured: At 3 months after commencement of treatment
intestinal microbiota before and after treatment with probiotics
Relative abundance of microbiome DNA in percentage
Measured: on date of randomization and at 3 month after completed treatment with probiotic or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Oct 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- B-Crobes Laboratory
- Responsible party
- Principal investigator, Prof Dr Nur Azurah Abd Ghani, National University of Malaysia
- Investigators
- Nur Azurah Abd Ghani, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119011
- Sponsor's protocol ID
- FF-2018-204
- Status last verified
- Feb 2021
- First submitted
- 30 Sep 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: clinical data sheet containing demographics, data collection (pain score, quality of life questionnaire, pain diary)
Publications
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.
PubMed 38444064
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04119011
- Acronym / sponsor ID
- FF-2018-204
- Conditions
- Primary Dysmenorrhea
- Keywords
- probiotics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- B-Crobes Laboratory
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Biological: ProbioticProbiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months |
| Placebo | Placebo comparator | Other: PlaceboPlacebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- regular menstrual cycles between 21 to 45 days
- primary dysmenorrhoea only
- willing to consume sachets twice daily for 3 months
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Probiotic |
| Placebolactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor | Other | Placebo |
Primary outcome
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
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
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
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
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
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
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
3 secondary outcomes
Concentration of inflammatory markers pre-treatment
Time frame: baseline
Concentration of inflammatory markers post-treatment
Time frame: At 3 months after commencement of treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 38444064Zakaria 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.
- Individual participant dataSharing planned: Yes. clinical data sheet containing demographics, data collection (pain score, quality of life questionnaire, pain diary)
Related trials for Primary Dysmenorrhea
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Azurah Abd Ghani principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Probiotic in people with Primary Dysmenorrhea, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score before treatment (visual analog scale VAS) (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.