β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Société des Produits Nestlé (SPN)41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Lactose Intolerance

Interventions

Positive controlOTHER

200ml milk containing 18g lactose

Probiotic S. thermophilusOTHER

200ml milk containing 18g lactose + probiotic S. thermophilus

Probiotic B. longumOTHER

200ml milk containing 18g lactose + probiotic B. longum

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Metabolic Unit

Lausanne, Switzerland

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.