Status:
COMPLETED
Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Lallemand Health Solutions
Conditions:
Menstrual Discomfort
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief 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 abdomina...
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 o...
Eligibility Criteria
Inclusion
- 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,
- 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).
Exclusion
- 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,
- Use of any antibiotic drug within 1 month of screening.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT04457401
Start Date
December 1 2020
End Date
June 1 2024
Last Update
June 28 2024
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611-0370