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N/A N=28 Randomized Double-blind Treatment

HYBRID: Hydrogen Breath Test in Lactose Digestion

Lactose Intolerance

Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Log of First Postprandial Peak Change of Hydrogen Concentration — 1.21; 1.10; 3.38; 3.59 log(ppm) — p=0.0801

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Fermented infant milk formula (Other); Non-fermented infant milk formula (Other)
Age
Adult · 21+ yrs
Sex
Male
Sponsor
Danone Asia Pacific Holdings Pte, Ltd.
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Log of First Postprandial Peak Change of Hydrogen Concentration
1.21; 1.10; 3.38; 3.59 0.0801
PRIMARY
Log of Maximum Postprandial Change in Hydrogen Concentration
1.21; 1.09; 3.70; 3.93 0.0714
SECONDARY
Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes
66.22; 75.78 0.0609

Summary

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

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02703987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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