β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Study Overview
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Brief Summary
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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
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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.

Official Title
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β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance

Conditions
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Lactose Intolerance

Intervention / Treatment
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* Other: Positive control
* Other: Probiotic S. thermophilus
* Other: Probiotic B. longum
* Other: Negative control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBT> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests Having signed the informed consent or having provide his/her legal representative's informed consent Exclusion Criteria: Known Food allergy Any obstructive (COPD, asthma…) or restrictive respiratory syndrome that may impact breath test measurements Any medically relevant malabsorption syndrome Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire Ongoing therapy with drugs known to affect gut motility Any general antibiotherapy taken during or within 4 weeks of study onset Use of lactase pill (eg. Lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to Visit 0b Subject who cannot be expected to comply with the study procedures Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study. To be a close collaborator to the Investigators, either in terms of Family relationship and/or professional relationship Pregnancy, based on anamnesis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive control<br>Ultra high temperature (UHT) milk containing 18 g total lactose | Other: Positive control<br>* 200ml milk containing 18g lactose<br>|
| Active Comparator: Positive control with S. thermophilus<br>UHT milk containing 18 g total lactose+ S. thermophilus | Other: Probiotic S. thermophilus<br>* 200ml milk containing 18g lactose + probiotic S. thermophilus<br>|
| Active Comparator: Positive control with B. longum<br>UHT milk containing 18 g total lactose+ B. longum | Other: Probiotic B. longum<br>* 200ml milk containing 18g lactose + probiotic B. longum<br>|
| Placebo Comparator: Negative control<br>Lactose free milk | Other: Negative control<br>* 200 ml of UHT Lactose free milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT) |  | HBT measured every hour during 4 hours after challenge (HBT curve) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 4 hours after every milk intake, from the time of ingestion up to 5 hours |