Menstrual DiscomfortNCT04457401
Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women
A study testing Probiotic in people with Menstrual Discomfort, run by University of Florida at 1 site in United States.
Trial summary
In this double blind, parallel study, female participants who are on an oral contraceptive will consume either a probiotic or placebo supplement for approximately 8 weeks. Menstrual cramp and abdominal pain severity, as measured by the visual analog scale, will be assessed daily. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Discomfort
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Jun 2024
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a healthy female between the ages of 18 and 35 years who has regular menstrual cycles (i.e., every 24 to 33 days),
- On the daily gastrointestinal symptom questionnaire for abdominal pain, participants must have a score of ≥ 3 for abdominal pain when thinking about their typical average score during first three days of menstruation,
- Be on an combination oral contraceptive,
- Willing and able to consume a probiotic or placebo supplement for approximately 8 weeks,
- Willing and able to complete daily and weekly questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided.),
- Willing to discontinue consumption of fermented foods or foods with live active cultures two weeks prior to beginning the study and throughout the study (This would include kefir, kombucha, yogurts with live, active cultures, etc.),
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- Willing to discontinue consumption of fiber supplements (This would include Metamucil, Benefiber, or other products with added fiber supplement.),
- Willing to complete a pregnancy test before consuming the study supplement,
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits,
- Able to provide informed consent,
- Willing to provide a stool and vaginal sample ten times during the study (subgroup),
- Typically have one stool per day (subgroup).
Who cannot join
- Women who have a birth control implant, vaginal ring, shot, or patch or intrauterine device,
- Women who are lactating, attempting to become pregnant, know that they are pregnant, or test positive on a pregnancy test,
- Women who have consumed probiotic supplements in the last month,
- Currently being treated for any physician-diagnosed diseases or conditions,
- Women who have been diagnosed with any gynecological diseases of conditions (fibroma, endometriosis, etc),
- Women who have pain that is caused by a disorder in the woman's reproductive organs. This would include a physician diagnosis such as endometriosis, adenomyosis, uterine fibroma, or a pelvic infection,
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- Allergy to milk, soy, or yeast,
- Use of another investigational product within 3 months of the screening visit,
- Use of any antibiotic drug within 1 month of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32611-0370
About this study
Official title: The Effect of a Probiotic on Gastrointestinal Symptoms Due to Menstruation in Healthy Adult Women: a Randomized, Double-blind, Controlled Clinical Trial
In this double blind, parallel study, female participants who are on an oral contraceptive will consume either a probiotic or placebo supplement for approximately 8 weeks. Menstrual cramp and abdominal pain severity, as measured by the visual analog scale, will be assessed daily. A subgroup of participants will be asked to provide vaginal swab and stool samples to assess microbial communities.
Read the detailed description
Participants recruited from the university community in the Southeast U.S. will participate in a randomized, double-blind, placebo-controlled interventional study for approximately 8 weeks following obtainment of informed consent. Participants will be asked to maintain their usual physical activity level as well as their usual diets with the exception of fermented foods, food containing added probiotics (e.g. yogurts with live, active cultures or supplements or probiotic supplements), or foods with added fiber supplements.
After obtaining consent, participants will be randomized to receive either the probiotic or placebo daily for 8 weeks. All study days will be ± 3 days to account for variation in each participant's menstrual cycle. The study supplements will be distributed approximately 7 days before their first menstrual event. Participants will be instructed to begin taking the study supplement 3 days after they menstruate.
At randomization, participants will be asked to start completing daily questionnaires inquiring about gastrointestinal symptoms, abdominal pain as measured by a visual analog scale, duration of abdominal pain, stool form and number, adverse events, and medications taken, including the dose and administration schedule. On the third day of their menstrual cycle (day 3/menstruation 1), they will begin consuming their study supplement (start of intervention). On the days participants experience gastrointestinal symptoms related to the menstrual cycle, they will answer an additional questionnaire asking about gastrointestinal symptoms. Approximately seven days prior to the first menstrual cycle (study day -7) and three days after each menstrual event (study day 3 and 31), participants will answer the Menstrual Symptom Questionnaire to assess symptoms leading up to and during menstruation. Seven days after each menstrual event (study days 7 and 35), participants will be administered the Perceived Stress Scale to assess stress levels over the previous month. Participants will also answer two validated weekly questionnaires inquiring about gastrointestinal symptoms and how symptoms affect quality of life each week they are in the study. Each participant will also complete a 24-hour dietary recall assessment at four points during the study (study day -7, 21, 28, and 35) in order to determine how dietary patterns fluctuate throughout the menstrual cycle. A subgroup of participants will be asked to provide six additional vaginal swab and stool samples and six additional dietary recalls.
A subgroup of 20 participants per arm will also be consented to provide ten stool samples and vaginal swabs during the study (study day -7, 1, 7, 14, 21, 28, 35, 42, 49, \& 56). Participants will be provided with stool and vaginal swab collection kits. Participants will self collect both of these samples and may either collect them at home or may use a restroom in the Food Science and Human Nutrition building to self collect. Coolers will be left outside of the building and in these restrooms for participants to drop off their samples. If social distancing is required during this study, participants will be asked to collect the samples at home and drop them off in a cooler outside of the building to ensure social distancing. This subgroup will also complete additional 24-hour dietary recalls (study day 1, 42, 49, \& 56).
Participants will continue to answer daily questionnaires until the third day of their third menstrual cycle, at which point they will discontinue answering questionnaires and consuming the study supplement. At the conclusion of the study, they will complete the final questionnaire that asks them which supplement they thought they were consuming to assess blinding efficacy. Participants will be instructed to return any unused supplements to the study site after the completion of the intervention.
- Conditions
- Menstrual Discomfort
- Being tested
- Probiotic, Placebo
- Keywords
- Gastrointestinal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
This probiotic is commercially available and contains Bifidobacterium (3 x 10^9 colony forming units/capsule) as the active ingredient and potato starch, magnesium stearate and ascorbic acid as excipients.
PlaceboDietary supplement
The placebo contains potato starch, magnesium stearate and ascorbic acid.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 1 capsule daily for 8 weeks, containing 3 x 10^9 colony forming units/capsule of a Bifidobacterium strain Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | 1 capsule daily for 8 weeks containing the same carrier material and is similar in size, shape and taste to probiotic Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain
The primary outcome is the change (average of the first 3 days of the second menstrual cycle during the study when on the intervention minus the average of the first 3 days of the first menstrual cycle during the study prior to initiating the intervention) in the daily Visual Analog Score for abdominal pain between women on the probiotic versus the placebo interventions. The visual analog scale is scored between 0 (not pain at all) - 100 (worst pain imaginable). A higher score is less desirable. While we anticipate that a menstrual cycle should last 28 days, there may be variability in this number due to variability in the length of each participant's menstrual cycle.
Measured: 28 days
Secondary outcomes (3)
Menstrual Symptom Questionnaire
The Menstrual Symptom Questionnaire assesses symptoms related to each menstrual cycle.
Measured: 28 days
Stool consistency
Compare stool consistency, as measured by the Bristol Stool Form Scale (BSFS), between the probiotic and placebo groups. The BSFS is scored between 1 (hard stool) - 7 (liquid stool). A score of 4 or 5 is ideal.
Measured: Each day up to 9 weeks
Stool frequency
Compare the number of stools between the probiotic and placebo groups.
Measured: Each day up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Dec 2020
- Primary completion2 Dec 2021
- Study completion1 Jun 2024
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 Menstrual DiscomfortStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled parallel study in which participants receive one of the study supplements (probiotic or placebo) for an 8-week intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457401
- Sponsor's protocol ID
- IRB201901746
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Judkins TC, Oula ML, Sims SM, Langkamp-Henken B. The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol. Trials. 2022 Jun 10;23(1):481. doi: 10.1186/s13063-022-06410-w.
PubMed 35689274
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Probiotic on Gastrointestinal Symptoms Due to Menstruation in Healthy Adult Women: a Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04457401
- Acronym / sponsor ID
- IRB201901746
- Conditions
- Menstrual Discomfort
- Keywords
- Gastrointestinal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 Jul 2020 (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.
In this double blind, parallel study, female participants who are on an oral contraceptive will consume either a probiotic or placebo supplement for approximately 8 weeks. Menstrual cramp and abdominal pain severity, as measured by the visual analog scale, will be assessed daily. A subgroup of participants will be asked to provide vaginal swab and stool samples to assess microbial communities.
Detailed description
Participants recruited from the university community in the Southeast U.S. will participate in a randomized, double-blind, placebo-controlled interventional study for approximately 8 weeks following obtainment of informed consent. Participants will be asked to maintain their usual physical activity level as well as their usual diets with the exception of fermented foods, food containing added probiotics (e.g. yogurts with live, active cultures or supplements or probiotic supplements), or foods with added fiber supplements.
After obtaining consent, participants will be randomized to receive either the probiotic or placebo daily for 8 weeks. All study days will be ± 3 days to account for variation in each participant's menstrual cycle. The study supplements will be distributed approximately 7 days before their first menstrual event. Participants will be instructed to begin taking the study supplement 3 days after they menstruate.
At randomization, participants will be asked to start completing daily questionnaires inquiring about gastrointestinal symptoms, abdominal pain as measured by a visual analog scale, duration of abdominal pain, stool form and number, adverse events, and medications taken, including the dose and administration schedule. On the third day of their menstrual cycle (day 3/menstruation 1), they will begin consuming their study supplement (start of intervention). On the days participants experience gastrointestinal symptoms related to the menstrual cycle, they will answer an additional questionnaire asking about gastrointestinal symptoms. Approximately seven days prior to the first menstrual cycle (study day -7) and three days after each menstrual event (study day 3 and 31), participants will answer the Menstrual Symptom Questionnaire to assess symptoms leading up to and during menstruation. Seven days after each menstrual event (study days 7 and 35), participants will be administered the Perceived Stress Scale to assess stress levels over the previous month. Participants will also answer two validated weekly questionnaires inquiring about gastrointestinal symptoms and how symptoms affect quality of life each week they are in the study. Each participant will also complete a 24-hour dietary recall assessment at four points during the study (study day -7, 21, 28, and 35) in order to determine how dietary patterns fluctuate throughout the menstrual cycle. A subgroup of participants will be asked to provide six additional vaginal swab and stool samples and six additional dietary recalls.
A subgroup of 20 participants per arm will also be consented to provide ten stool samples and vaginal swabs during the study (study day -7, 1, 7, 14, 21, 28, 35, 42, 49, \& 56). Participants will be provided with stool and vaginal swab collection kits. Participants will self collect both of these samples and may either collect them at home or may use a restroom in the Food Science and Human Nutrition building to self collect. Coolers will be left outside of the building and in these restrooms for participants to drop off their samples. If social distancing is required during this study, participants will be asked to collect the samples at home and drop them off in a cooler outside of the building to ensure social distancing. This subgroup will also complete additional 24-hour dietary recalls (study day 1, 42, 49, \& 56).
Participants will continue to answer daily questionnaires until the third day of their third menstrual cycle, at which point they will discontinue answering questionnaires and consuming the study supplement. At the conclusion of the study, they will complete the final questionnaire that asks them which supplement they thought they were consuming to assess blinding efficacy. Participants will be instructed to return any unused supplements to the study site after the completion of the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled parallel study in which participants receive one of the study supplements (probiotic or placebo) for an 8-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic1 capsule daily for 8 weeks, containing 3 x 10^9 colony forming units/capsule of a Bifidobacterium strain |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule daily for 8 weeks containing the same carrier material and is similar in size, shape and taste to probiotic |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Be a healthy female between the ages of 18 and 35 years who has regular menstrual cycles (i.e., every 24 to 33 days),
- On the daily gastrointestinal symptom questionnaire for abdominal pain, participants must have a score of ≥ 3 for abdominal pain when thinking about their typical average score during first three days of menstruation,
- Be on an combination oral contraceptive,
- Willing and able to consume a probiotic or placebo supplement for approximately 8 weeks,
- Willing and able to complete daily and weekly questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided.),
Key exclusion criteria (9 listed)
- Women who have a birth control implant, vaginal ring, shot, or patch or intrauterine device,
- Women who are lactating, attempting to become pregnant, know that they are pregnant, or test positive on a pregnancy test,
- Women who have consumed probiotic supplements in the last month,
- Currently being treated for any physician-diagnosed diseases or conditions,
- Women who have been diagnosed with any gynecological diseases of conditions (fibroma, endometriosis, etc),
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 |
|---|---|---|
| ProbioticThis probiotic is commercially available and contains Bifidobacterium (3 x 10^9 colony forming units/capsule) as the active ingredient and potato starch, magnesium stearate and ascorbic acid as excipients. | Dietary supplement | Probiotic |
| PlaceboThe placebo contains potato starch, magnesium stearate and ascorbic acid. | Dietary supplement | Placebo |
Primary outcome
Abdominal Pain
Time frame: 28 days
The primary outcome is the change (average of the first 3 days of the second menstrual cycle during the study when on the intervention minus the average of the first 3 days of the first menstrual cycle during the study prior to initiating the intervention) in the daily Visual Analog Score for abdominal pain between women on the probiotic versus the placebo interventions. The visual analog scale is scored between 0 (not pain at all) - 100 (worst pain imaginable). A higher score is less desirable. While we anticipate that a menstrual cycle should last 28 days, there may be variability in this number due to variability in the length of each participant's menstrual cycle.
3 secondary outcomes
Menstrual Symptom Questionnaire
Time frame: 28 days
Stool consistency
Time frame: Each day up to 9 weeks
Stool frequency
Time frame: Each day up to 9 weeks
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 28 Jun 2024.
- Derived from this study: PubMed 35689274Judkins TC, Oula ML, Sims SM, Langkamp-Henken B. The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol. Trials. 2022 Jun 10;23(1):481. doi: 10.1186/s13063-022-06410-w.
- Individual participant dataSharing planned: No
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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.
Bobbi Langkamp-Henken, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Menstrual Discomfort, run by University of Florida at 1 site in United States.
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 12 inclusion and 9 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 28 Jun 2024. 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 United States. 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.
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?
Abdominal Pain (time frame: 28 days). 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 NCT04457401, 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 28 Jun 2024.