HYBRID: Hydrogen Breath Test in Lactose Digestion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.

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Detailed Description

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Conditions

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Lactose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group I

Fermented infant milk formula

Group Type EXPERIMENTAL

Fermented infant milk formula

Intervention Type OTHER

Group II

Non-fermented infant milk formula

Group Type ACTIVE_COMPARATOR

Non-fermented infant milk formula

Intervention Type OTHER

Interventions

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Fermented infant milk formula

Intervention Type OTHER

Non-fermented infant milk formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

BMI between 18.5 and 24.9 kg/m2 inclusive Lactose intolerant

The following criteria need to be checked at visit 2:

* Lactose intolerance confirmed by positive Hydrogen Breath Test (HBT) (i.e. if there are two or more samples with hydrogen level \> 20 ppm increase compared to baseline sample between 90 mins and 240 min sampling time point).
* At least one sample with hydrogen level \> 20 ppm increase compared to baseline between 90 mins and 180 mins sampling time point.

Exclusion Criteria

History of gastrointestinal disorders Current illness which could interfere with the study (e.g. diarrhea, regurgitation) Any history of cow's milk protein allergy or known allergy to galacto-oligosaccharides Any current participation or within 8 weeks of study start, in any other study involving investigational or marketed products, any medical procedures, or any surgical methods.

Any antibiotic, laxative or colonic cleansing treatments within 4 weeks of study start Any administration of probiotic in the 1 week prior to study start Investigator's uncertainty about willingness or ability of subject to comply with protocol requirements

The following criteria need to be checked at visit 2:

* Level of hydrogen \> 20 ppm in the baseline breath sample.
* An early peak of hydrogen (i.e. hydrogen level \> 20 ppm increase compared to baseline value) in the first 60 minutes after ingestion of the study products.

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes