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β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

NCT ID: NCT02518295

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

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.

Conditions

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Lactose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Positive control

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

Group Type ACTIVE_COMPARATOR

Positive control

Intervention Type OTHER

200ml milk containing 18g lactose

Positive control with S. thermophilus

UHT milk containing 18 g total lactose+ S. thermophilus

Group Type ACTIVE_COMPARATOR

Probiotic S. thermophilus

Intervention Type OTHER

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

Positive control with B. longum

UHT milk containing 18 g total lactose+ B. longum

Group Type ACTIVE_COMPARATOR

Probiotic B. longum

Intervention Type OTHER

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

Negative control

Lactose free milk

Group Type PLACEBO_COMPARATOR

Negative control

Intervention Type OTHER

200 ml of UHT Lactose free milk

Interventions

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Positive control

200ml milk containing 18g lactose

Intervention Type OTHER

Probiotic S. thermophilus

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

Intervention Type OTHER

Probiotic B. longum

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

Intervention Type OTHER

Negative control

200 ml of UHT Lactose free milk

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Duboux

Role: STUDY_DIRECTOR

Société des Produits Nestlé (SPN)

Gabriela Bergonzelli, PhD

Role: STUDY_DIRECTOR

Société des Produits Nestlé (SPN)

Locations

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Metabolic Unit

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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14.33. MET

Identifier Type: -

Identifier Source: org_study_id