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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive control | Active Comparator | Ultra high temperature (UHT) milk containing 18 g total lactose |
|
| Positive control with S. thermophilus | Active Comparator | UHT milk containing 18 g total lactose+ S. thermophilus |
|
| Positive control with B. longum | Active Comparator | UHT milk containing 18 g total lactose+ B. longum |
|
| Negative control | Placebo Comparator | Lactose free milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive control | Other | 200ml milk containing 18g lactose |
| |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Duboux | Société des Produits Nestlé (SPN) | Study Director |
| Gabriela Bergonzelli, PhD | Société des Produits Nestlé (SPN) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Unit | Lausanne | CH-1000 | Switzerland |
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| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Probiotic S. thermophilus |
| Other |
200ml milk containing 18g lactose + probiotic S. thermophilus |
|
| Probiotic B. longum | Other | 200ml milk containing 18g lactose + probiotic B. longum |
|
| Negative control | Other | 200 ml of UHT Lactose free milk |
|
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |