Back to results

β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Primary Purpose

Lactose Intolerance

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Positive control

Probiotic S. thermophilus

Probiotic B. longum

Negative control

About this trial

This is an interventional supportive care trial for Lactose Intolerance

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Metabolic Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Positive control

Positive control with S. thermophilus

Positive control with B. longum

Negative control

Arm Description

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

UHT milk containing 18 g total lactose+ S. thermophilus

UHT milk containing 18 g total lactose+ B. longum

Lactose free milk

Outcomes

Primary Outcome Measures

Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02518295

First Posted

July 16, 2015

Last Updated

November 29, 2016

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT02518295

Brief Title

β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lactose Intolerance

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Positive control

Arm Type

Active Comparator

Arm Description

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

Arm Title

Positive control with S. thermophilus

Arm Type

Active Comparator

Arm Description

UHT milk containing 18 g total lactose+ S. thermophilus

Arm Title

Positive control with B. longum

Arm Type

Active Comparator

Arm Description

UHT milk containing 18 g total lactose+ B. longum

Arm Title

Negative control

Arm Type

Placebo Comparator

Arm Description

Lactose free milk

Intervention Type

Other

Intervention Name(s)

Positive control

Intervention Description

200ml milk containing 18g lactose

Intervention Type

Other

Intervention Name(s)

Probiotic S. thermophilus

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Probiotic B. longum

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Negative control

Intervention Description

200 ml of UHT Lactose free milk

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stéphane Duboux

Organizational Affiliation

Société des Produits Nestlé (SPN)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gabriela Bergonzelli, PhD

Organizational Affiliation

Société des Produits Nestlé (SPN)

Official's Role

Study Director

Facility Information:

Facility Name

Metabolic Unit

City

Lausanne

ZIP/Postal Code

CH-1000

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

We'll reach out to this number within 24 hrs