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 range18 Years – 35 Years
SexFEMALE
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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.),
✓. 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,