β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Lactose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518295
• Other study ID #: 14.33. MET
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: November 29, 2016
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

Other:
• Positive control
200ml milk containing 18g lactose
• Probiotic S. thermophilus
200ml milk containing 18g lactose + probiotic S. thermophilus
• Probiotic B. longum
200ml milk containing 18g lactose + probiotic B. longum
• Negative control
200 ml of UHT Lactose free milk

Locations

Country	Name	City	State
Switzerland	Metabolic Unit	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No