β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

NCT02518295 | Completed DMC

• 1 other identifier: 14.33. MET
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

Positive control

ACTIVE COMPARATOR

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

Other: Positive control

Positive control with S. thermophilus

ACTIVE COMPARATOR

UHT milk containing 18 g total lactose+ S. thermophilus

Other: Probiotic S. thermophilus

Positive control with B. longum

ACTIVE COMPARATOR

UHT milk containing 18 g total lactose+ B. longum

Other: Probiotic B. longum

Negative control

PLACEBO COMPARATOR

Lactose free milk

Other: Negative control

Interventions

Positive control OTHER

200ml milk containing 18g lactose

Positive control

Probiotic S. thermophilus OTHER

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

Positive control with S. thermophilus

Probiotic B. longum OTHER

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

Positive control with B. longum

Negative control OTHER

200 ml of UHT Lactose free milk

Negative control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Metabolic Unit

Lausanne, CH-1000, Switzerland

Location

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stéphane Duboux

  Société des Produits Nestlé (SPN)

  STUDY DIRECTOR

• Gabriela Bergonzelli, PhD

  Société des Produits Nestlé (SPN)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: August 7, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

CH (1)