Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

Inclusion criteria

• Voluntary, written, informed consent to participate in the study
• Agreement to comply with the protocol and study restrictions
• Healthy females and males of age 25 to 60 years (inclusive)
• Self-declared, suspected or medically diagnosed lactose intolerance
• Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting breath hydrogen value
• Participants who agree to maintain their usual dietary habits throughout the trial period
• 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)
• Females of child-bearing potential who agree to use a medically approved method of birth control
• 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
• Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research

Exclusion criteria

• 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)
• Diagnosed type 1 or type 2 diabetes
• Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or affect study results
• Ongoing or recent (last 1 month) antibiotic treatment.
• Use of laxatives or drugs known to affect gut motility 1 month preceding the screening visit and during the study
• Ongoing or recurrent use of proton pump inhibitors
• Colonoscopy within 3 months before screening
• History of recurrent colon cleansing and/or a colon cleansing within 3 months before screening
• Gastrointestinal infection within 1 month before screening or during the trial
• 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)
• History of diagnosed coronary heart disease/cardiovascular disease or artificial heart valve
• Any obstructive or restrictive respiratory syndrome/disease that may impact breath test (e.g. asthma or chronic obstructive pulmonary disease (COPD))
• 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.
• 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)
• Self-declared use of illicit drugs within 4 weeks preceding the screening visit
• Pregnant or lactating female, or pregnancy planned during study period
• Participants under administrative or legal supervision.
• Participation in another study with any investigational product within 60 days of screening
• Clinically significant abnormal values in safety blood tests at screening
• Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
• 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.