Status:
COMPLETED
Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution
Lead Sponsor:
Danisco
Conditions:
Lactose Intolerance
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
Study objectives: Primary: Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo, measured by the incremental area under curve (iAUC) analysis N...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03814668
Start Date
November 5 2018
End Date
April 30 2019
Last Update
August 13 2019
Active Locations (1)
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1
Eurofins Optimed
Gières, France, 38610