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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

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.

Condition or disease Intervention/treatment Phase
Lactose Intolerance Other: Positive control Other: Probiotic S. thermophilus Other: Probiotic B. longum Other: Negative control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Positive control
Ultra high temperature (UHT) milk containing 18 g total lactose
Other: Positive control
200ml milk containing 18g lactose

Active Comparator: Positive control with S. thermophilus
UHT milk containing 18 g total lactose+ S. thermophilus
Other: Probiotic S. thermophilus
200ml milk containing 18g lactose + probiotic S. thermophilus

Active Comparator: Positive control with B. longum
UHT milk containing 18 g total lactose+ B. longum
Other: Probiotic B. longum
200ml milk containing 18g lactose + probiotic B. longum

Placebo Comparator: Negative control
Lactose free milk
Other: Negative control
200 ml of UHT Lactose free milk




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02518295


Locations
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Switzerland
Metabolic Unit
Lausanne, Switzerland, CH-1000
Sponsors and Collaborators
Nestlé
Investigators
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Study Director: Stéphane Duboux Nestlé
Study Director: Gabriela Bergonzelli, PhD Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02518295    
Other Study ID Numbers: 14.33. MET
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016
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
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents