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β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

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: NCT02518295
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE July 16, 2015
First Posted Date  ICMJE August 7, 2015
Last Update Posted Date November 30, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT) [ Time Frame: HBT measured every hour during 4 hours after challenge (HBT curve) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
Assessment of improvement of lactose intolerance symptoms using a composite score equal to the sum of individual symptoms measured using a visual analog scale (VAS) [ Time Frame: 4 hours after every milk intake, from the time of ingestion up to 5 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion
Official Title  ICMJE β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance
Brief Summary The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.
Detailed Description

The trial will be cross over, randomized in incomplete blocks, controlled, double-blind:

each subject will be administered 3 products out of 4 (positive control, probiotic Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge.

The total sample size is 42 enrolled subjects/37 completed Patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Lactose Intolerance
Intervention  ICMJE
  • Other: Positive control
    200ml milk containing 18g lactose
  • Other: Probiotic S. thermophilus
    200ml milk containing 18g lactose + probiotic S. thermophilus
  • Other: Probiotic B. longum
    200ml milk containing 18g lactose + probiotic B. longum
  • Other: Negative control
    200 ml of UHT Lactose free milk
Study Arms  ICMJE
  • Active Comparator: Positive control
    Ultra high temperature (UHT) milk containing 18 g total lactose
    Intervention: Other: Positive control
  • Active Comparator: Positive control with S. thermophilus
    UHT milk containing 18 g total lactose+ S. thermophilus
    Intervention: Other: Probiotic S. thermophilus
  • Active Comparator: Positive control with B. longum
    UHT milk containing 18 g total lactose+ B. longum
    Intervention: Other: Probiotic B. longum
  • Placebo Comparator: Negative control
    Lactose free milk
    Intervention: Other: Negative control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2016)
41
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2015)
32
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. HBT> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests
  2. Having signed the informed consent or having provide his/her legal representative's informed consent

Exclusion Criteria:

  1. Known Food allergy
  2. Any obstructive (COPD, asthma…) or restrictive respiratory syndrome that may impact breath test measurements
  3. Any medically relevant malabsorption syndrome
  4. Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire
  5. Ongoing therapy with drugs known to affect gut motility
  6. Any general antibiotherapy taken during or within 4 weeks of study onset
  7. Use of lactase pill (eg. Lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to Visit 0b
  8. Subject who cannot be expected to comply with the study procedures
  9. Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
  10. To be a close collaborator to the Investigators, either in terms of Family relationship and/or professional relationship
  11. Pregnancy, based on anamnesis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02518295
Other Study ID Numbers  ICMJE 14.33. MET
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stéphane Duboux Nestlé
Study Director: Gabriela Bergonzelli, PhD Nestlé
PRS Account Nestlé
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP