β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Nestlé

Status: Completed

Conditions: Lactose Intolerance

Treatments: Other: Probiotic B. longum; Other: Positive control; Other: Probiotic S. thermophilus; Other: Negative control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02518295

14.33. MET

Details and patient eligibility

About

The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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41 participants in 4 patient groups, including a placebo group

Positive control

Active Comparator group

Description:

Ultra high temperature (UHT) milk containing 18 g total lactose

Treatment:

Other: Positive control

Positive control with S. thermophilus

Active Comparator group

Description:

UHT milk containing 18 g total lactose+ S. thermophilus

Treatment:

Other: Probiotic S. thermophilus

Positive control with B. longum

Active Comparator group

Description:

UHT milk containing 18 g total lactose+ B. longum

Treatment:

Other: Probiotic B. longum

Negative control

Placebo Comparator group

Description:

Lactose free milk

Treatment:

Other: Negative control