HYBRID: Hydrogen Breath Test in Lactose Digestion

NCT02703987 | Completed Results

• 1 other identifier: Dig.1.C.I/0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes

  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

Study Arms (2)

Group I

EXPERIMENTAL

Fermented infant milk formula

Other: Fermented infant milk formula

Group II

ACTIVE COMPARATOR

Non-fermented infant milk formula

Other: Non-fermented infant milk formula

Interventions

Fermented infant milk formula OTHER

Group I

Non-fermented infant milk formula OTHER

Group II

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Danone Nutricia Research
• Organization: Danone Nutricia Research

register.clinicalresearchnutricia@danone.com

Study Officials

• Ngai Moh Law

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 18, 2020
• Results First Posted: March 4, 2020

Record last verified: 2020-03

Locations

SG (1)