Clinical trial: Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women (NCT04457401)

Eligibility criteria:
Inclusion Criteria:

          1. Be a healthy female between the ages of 18 and 35 years who has regular menstrual
             cycles (i.e., every 24 to 33 days),

          2. 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,

          3. Be on an combination oral contraceptive,

          4. Willing and able to consume a probiotic or placebo supplement for approximately 8
             weeks,

          5. 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.),

          6. 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.),

          7. Willing to discontinue consumption of fiber supplements (This would include Metamucil,
             Benefiber, or other products with added fiber supplement.),

          8. Willing to complete a pregnancy test before consuming the study supplement,

          9. Willingness to complete questionnaires, records, and diaries associated with the study
             and to complete all study visits,

         10. Able to provide informed consent,

         11. Willing to provide a stool and vaginal sample ten times during the study (subgroup),

         12. Typically have one stool per day (subgroup).

        Exclusion Criteria:

          1. Women who have a birth control implant, vaginal ring, shot, or patch or intrauterine
             device,

          2. Women who are lactating, attempting to become pregnant, know that they are pregnant,
             or test positive on a pregnancy test,

          3. Women who have consumed probiotic supplements in the last month,

          4. Currently being treated for any physician-diagnosed diseases or conditions,

          5. Women who have been diagnosed with any gynecological diseases of conditions (fibroma,
             endometriosis, etc),

          6. 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,

          7. Allergy to milk, soy, or yeast,

          8. Use of another investigational product within 3 months of the screening visit,

          9. Use of any antibiotic drug within 1 month of screening.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction