Clinical trial: Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution (NCT03814668)

Eligibility criteria:
Inclusion Criteria:

          1. Voluntary, written, informed consent to participate in the study

          2. Agreement to comply with the protocol and study restrictions

          3. Healthy females and males of age 25 to 60 years (inclusive)

          4. Self-declared, suspected or medically diagnosed lactose intolerance

          5. Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting
             breath hydrogen value

          6. Participants who agree to maintain their usual dietary habits throughout the trial
             period

          7. Participants who agree not to consume probiotics, prebiotics, fermented milk, and/or
             yogurt containing probiotics during the intervention period (Visits 3-5) and two weeks
             before Visit 3 (2 weeks after screening visit)

          8. Females of child-bearing potential who agree to use a medically approved method of
             birth control

          9. Ability of the participant (in the investigator's opinion) to comprehend the full
             nature and purpose of the study including possible risks and side effects

         10. Covered by Health Insurance System and / or in compliance with the recommendations of
             National Law in force relating to biomedical research

        Exclusion Criteria:

          1. Gastrointestinal disorder or disease (e.g. Crohn's disease, ulcer, irritable bowel
             syndrome (IBS), Celiac disease, small intestinal bacterial overgrowth (SIBO),
             pancreatitis and disorders affecting gastrointestinal motility)

          2. Diagnosed type 1 or type 2 diabetes

          3. Prior abdominal surgery that, in the opinion of the investigator, may present a risk
             for the participant or affect study results

          4. Ongoing or recent (last 1 month) antibiotic treatment.

          5. Use of laxatives or drugs known to affect gut motility 1 month preceding the screening
             visit and during the study

          6. Ongoing or recurrent use of proton pump inhibitors

          7. Colonoscopy within 3 months before screening

          8. History of recurrent colon cleansing and/or a colon cleansing within 3 months before
             screening

          9. Gastrointestinal infection within 1 month before screening or during the trial

         10. Clinically significant underlying systemic illness that may preclude the participant's
             ability to complete the trial or that may affect the study outcomes (e.g. bowel
             cancer, prostate cancer, terminal illness)

         11. History of diagnosed coronary heart disease/cardiovascular disease or artificial heart
             valve

         12. Any obstructive or restrictive respiratory syndrome/disease that may impact breath
             test (e.g. asthma or chronic obstructive pulmonary disease (COPD))

         13. Regular use of tobacco, snuff, nicotine and e-cigarette, and possible other inhaled
             products. Light smokers (less than 5 cigarettes per day) who agree not to smoke during
             the whole duration of the study may be included.

         14. Self-declared history of alcohol abuse (for females: >3 drinks on any single day and
             >7 drinks per week; for males: >4 drinks on any single day and >14 drinks per week)

         15. Self-declared use of illicit drugs within 4 weeks preceding the screening visit

         16. Pregnant or lactating female, or pregnancy planned during study period

         17. Participants under administrative or legal supervision.

         18. Participation in another study with any investigational product within 60 days of
             screening

         19. Clinically significant abnormal values in safety blood tests at screening

         20. Other reasons that, in the opinion of the Investigator, make the participant
             unsuitable for enrolment

         21. Who would receive more than 4500€ as indemnities for his participation in biomedical
             research within the last 12 months, including the indemnities for the present study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction