β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02518295

Enrollment

Registered

2015-08-07

Start date

2015-09-30

Completion date

2016-09-30

Last updated

2016-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactose Intolerance

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.

Interventions

OTHERPositive control

200ml milk containing 18g lactose

OTHERProbiotic S. thermophilus

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

OTHERProbiotic B. longum

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

OTHERNegative control

200 ml of UHT Lactose free milk

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026