HYBRID: Hydrogen Breath Test in Lactose Digestion
Lactose Intolerance
Bottom Line
View on ClinicalTrials.gov: NCT02703987 ↗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
| Outcome | Result | p-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
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.
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.