β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Not Applicable

Completed

• Conditions: Lactose Intolerance
• Interventions: Other: Positive control; Other: Probiotic S. thermophilus; Other: Probiotic B. longum; Other: Negative control

• Registration Number: NCT02518295
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Study Start: 2015-09
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Positive control	Positive control	Ultra high temperature (UHT) milk containing 18 g total lactose
Positive control with S. thermophilus	Probiotic S. thermophilus	UHT milk containing 18 g total lactose+ S. thermophilus
Positive control with B. longum	Probiotic B. longum	UHT milk containing 18 g total lactose+ B. longum
Negative control	Negative control	Lactose free milk

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Metabolic Unit; 🇨🇭 Lausanne, Switzerland