Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women (NCT04457401) | Clinical Trial Compass
CompletedNot Applicable
Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women
United States187 participantsStarted 2020-12-01
Plain-language 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. A subgroup of participants will be asked to provide vaginal swab and stool samples to assess microbial communities.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.),
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.),
. 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,
Exclusion criteria
. 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,
. Allergy to milk, soy, or yeast,
. Use of another investigational product within 3 months of the screening visit,