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Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814668
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Danisco

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

Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group, measured by the incremental area under curve (iAUC) analysis

Secondary:

Breath test

  • Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo
  • Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo

Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert scale) in lactase and probiotic groups compared to placebo

  • Abdominal pain
  • Flatulence
  • Bloating
  • Nausea and vomiting
  • Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol stool scale and number of bowel movements to be recorded)

Ancillary:

  • Baseline fasting BHC (ppm)
  • Breath methane CH4 (ppm)
  • Breath carbon dioxide CO2 (ppm)
  • Probiotic identification in feces before each lactose challenge by molecular methods
  • Gene test to determine lactase deficiency status at screening (following SNP variants to be screened: 13910*C (Europe, Central Asia, commonly used) -22018*G (Europe), -13915*T (Saudi-Arabia, Africa), -14010*G (Africa), -13907*C (Africa))

Condition or disease Intervention/treatment Phase
Lactose Intolerance Dietary Supplement: Probiotic Dietary Supplement: Lactase Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution: Randomized, Double-blind, Placebo-controlled, Positive-controlled, Three-way Crossover, Acute Lactose Challenge
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic powder
One sachet of Probiotic powderwill be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.
Dietary Supplement: Probiotic
Intake of probiotic

Active Comparator: Lactase
One sachet of Lactase powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.
Dietary Supplement: Lactase
Intake of lactase

Placebo Comparator: Placebo
One sachet of placebo powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.
Other: Placebo
Intake of placebo




Primary Outcome Measures :
  1. Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath hydrogen concentration (BHC, ppm) in probiotic compared to placebo, measured by the iAUC analysis

  2. Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis

  3. Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control) [ Time Frame: During the 6-hour acute lactose challenge ]
    Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis


Secondary Outcome Measures :
  1. Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value

  2. Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value

  3. Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value

  4. Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value

  5. Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  6. Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of abdominal pain in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey

  7. Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  8. Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey

  9. Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  10. Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey

  11. Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  12. Difference in the severity of nausea in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the severity of nausea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey

  13. Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  14. Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey

  15. Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  16. Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey

  17. Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  18. Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey


Other Outcome Measures:
  1. Difference in baseline fasting BHC (ppm) between the treatments [ Time Frame: Baseline ]
    Difference in baseline fasting BHC (ppm) between the treatments

  2. Difference in breath methane concentration (ppm) between the treatments [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath methane concentration (ppm) between the treatments

  3. Difference in breath carbon dioxide concentration (ppm) between the treatments [ Time Frame: During the 6-hour acute lactose challenge ]
    Difference in breath methane concentration (ppm) between the treatments

  4. Difference in the quantity of probiotic in fecal samples between the treatments [ Time Frame: 48-hours before the visits ]
    Difference in the quantity of probiotic in fecal samples between the treatments

  5. Description of the SNP variants in each treatment group [ Time Frame: At screening ]
    Description of the SNP variants in each treatment group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814668


Locations
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France
Eurofins Optimed
Gières, France, 38610
Sponsors and Collaborators
Danisco

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Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT03814668    
Other Study ID Numbers: NH-03978
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases