HYBRID: Hydrogen Breath Test in Lactose Digestion (HYBRID)

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

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

Study Overview

• Status: Completed
• Conditions: Lactose Intolerance
• Intervention / Treatment: Other: Fermented infant milk formula; Other: Non-fermented infant milk formula

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log of First Postprandial Peak Change of Hydrogen Concentration	This is measured as the log of the first change >20ppm peak value compared to baseline between 90 minutes and 240 minutes. If there was no change >20ppm at all between 90 minutes and 240 minutes, it is the maximum change compared to baseline in that interval	Postprandial peak hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4
Log of Maximum Postprandial Change in Hydrogen Concentration	This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes	Maximum postprandial hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes	The iAUC of hydrogen concentration from 30 to 240 minute sampling time points is calculated with the triangular rule (reference: Wolever TM. Effect of blood sampling schedule and method of calculating the area under the curve on validity and precision of glycaemic index values. Br J Nutr. 2004 Feb;91(2):295-301). The square root of the iAUC is then taken for the outcome measure	Hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 30, 60, 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Investigators: Principal Investigator: Ngai Moh Law, Changi General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: Dig.1.C.I/0