Clinical trial: A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults (NCT04223388)

Eligibility criteria:
Inclusion Criteria:

          1. Females and males between 18 to 55 years of age, inclusive

          2. BMI between 18.5 to 32 kg/m2, inclusive

          3. Self-reported history of diarrhea over the last 3 months, defined as > 5 BMs with the
             majority (≥ 50%) of the BMs per week being Bristol stool form types ≥5, 6 or 7

          4. Female participant is not of child bearing potential, which is defined as females who
             have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete
             endometrial ablation, or are post-menopausal (natural or surgically with > 1 year
             since last menstruation) OR,

             Females of childbearing potential must agree to use a medically approved method of
             birth control and must have negative urine pregnancy test results at screening and
             baseline. A minimum of 3-months stable dose is required for females on a hormonal
             birth control. Acceptable methods of birth control include:

             I. Hormonal contraceptives including oral contraceptives, hormone birth control patch
             (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives
             (Depo-Provera, Lunelle), or hormone implant (Norplant System) II. Double-barrier
             method III. Intrauterine devices IV. Non-heterosexual lifestyle or agrees to use
             contraception if planning on changing to heterosexual partner(s) V. Vasectomy of
             partner (shown successful as per appropriate follow-up)

          5. Healthy as determined by laboratory results, medical history and physical exam by QI

          6. Agrees to comply with all study procedures

          7. Agrees to refrain from the use of any home remedies to control GI issues if live
             bacteria may be involved

          8. Agrees to avoid NSAIDs and Steroids for 72 hours and Vitamin C and related supplements
             for 24 hours prior to fecal zonulin sample collection

          9. Agrees to maintain current level of physical activity and diet throughout the study

         10. Agrees to provide written informed consent

        Exclusion Criteria:

          1. Women who are pregnant, breast feeding, or planning to become pregnant during the
             trial

          2. Allergy or sensitivity to investigational product's active or inactive ingredients

          3. Clinically significant abnormal laboratory results at screening as assessed by QI

          4. Chronic use of anti-diarrhea medications and supplements; occasional use is permitted
             based on frequency of use and appropriate wash-out to be determined by QI

          5. Currently undergoing pharmacological treatment for IBS, or history of active treatment
             for IBS within the last 1 year

          6. Clinically significant disease of the gastrointestinal tract (examples include but are
             not limited to celiac disease, gluten intolerance/sensitivity, inflammatory bowel
             disease)

          7. Gastrointestinal surgery within the past 3 months. Gastrointestinal surgery > 3 months
             ago, will be assessed by the QI on a case-by-case basis.

          8. Major surgery in the past 3 months or individuals who have planned surgery during the
             course of the trial. Minor surgery will be considered on a case by case basis by QI

          9. Cancer, except skin cancers completely excised with no chemotherapy or radiation with
             a follow up that is negative. Cancer in full remission for more than five years after
             diagnosis are acceptable.

         10. Verbal confirmation of autoimmune disease or if immune-compromised

         11. Verbal confirmation of HIV, hepatitis B/C positive diagnosis

         12. Metabolic syndrome or chronic diseases to be assessed by QI on a case by case basis

         13. Type I or Type II diabetes

         14. Significant cardiovascular event in the past 6 months. No significant cardiovascular
             event on stable medication may be included after assessment by the QI on a case by
             case basis

         15. History or currently with kidney and liver diseases assessed by QI on a case by case
             basis, with the exception of the history of kidney stones symptom-free for 1 year

         16. Verbal confirmation of current or pre-existing thyroid condition. Treatment on a
             stable dose medication for over 6 months will be reviewed on a case-by-case basis by
             the QI

         17. Blood or bleeding disorders, with the exception of a history of anemia caused by
             deficiency of a mineral or vitamin, and no longer present

         18. Current use or consumption of antibiotics in the 4 weeks prior to baseline

         19. Current use or consumption of prebiotic or probiotic or synbiotic supplements in the 4
             weeks prior to baseline

         20. Current use of prescribed medications that may affect the study outcomes

         21. Use of over-the-counter (OTC) medications or supplements or consumption of
             foods/drinks that may affect the study outcomes, unless willing to undergo an
             appropriate washout period prior to baseline is agreed upon after assessment by the QI

         22. Use of medical marijuana

         23. Chronic use of recreational marijuana; infrequent use (>30 days since last use) to be
             assessed by QI

         24. Use of tobacco products unless quit 90 days prior to baseline

         25. Alcohol or drug abuse in the past year

         26. High alcohol intake (average of >2 standard drinks per day or >10 standard drinks per
             week)

         27. Use of narcotics

         28. Illicit drug use in the past 6 months as assessed by the QI

         29. Participation in other clinical research trials 30 days prior to randomization or will
             be participating in another investigation during the study

         30. Participants who plan to donate blood during the study or within 30 days of completing
             the study

         31. Any known (choric or acute) medical or neuropsychological condition that, in the QI's
             opinion, could interfere with study participation, or individuals who are cognitively
             impaired and/or who are unable to give informed consent

         32. Any other active or unstable medical condition, that, in the opinion of the QI, may
             adversely affect the participant's ability to complete the study or its measures or
             pose a significant risk to the participant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 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