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HYBRID: Hydrogen Breath Test in Lactose Digestion (HYBRID)

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ClinicalTrials.gov Identifier: NCT02703987
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.

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

Condition or disease Intervention/treatment Phase
Lactose Intolerance Other: Fermented infant milk formula Other: Non-fermented infant milk formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-blind, Cross-over, Single-centre Study to Investigate the Effect of a Fermented Infant Formula on Lactose Digestion in Lactose Intolerant Adults
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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Arm Intervention/treatment
Experimental: Group I
Fermented infant milk formula
Other: Fermented infant milk formula
Active Comparator: Group II
Non-fermented infant milk formula
Other: Non-fermented infant milk formula



Primary Outcome Measures :
  1. Postprandial peak hydrogen in breath [ Time Frame: 4 hours ]
    First peak of increased hydrogen concentration and maximum peak of hydrogen concentration between groups



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703987


Locations
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Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
Investigators
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Principal Investigator: Ngai Moh Law Changi General Hospital

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Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT02703987     History of Changes
Other Study ID Numbers: Dig.1.C.I/0
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases