HYBRID: Hydrogen Breath Test in Lactose Digestion

Danone

Status

Completed

Conditions

Lactose Intolerance

Treatments

Other: Fermented infant milk formula

Other: Non-fermented infant milk formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT02703987

Dig.1.C.I/0

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

Male

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.