Lactose IntoleranceHYBRIDNCT02703987

HYBRID: Hydrogen Breath Test in Lactose Digestion

A study testing Fermented infant milk formula and Non-fermented infant milk formula in people with Lactose Intolerance, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 21 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Lactose Intolerance
What is being tested?: Fermented infant milk formula and Non-fermented infant milk formula
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSingapore
Study dates: Nov 2015to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

Changi General Hospital
Singapore, 529889

Other trials in Singapore

About this study

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

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
Being tested: Fermented infant milk formula, Non-fermented infant milk formula
Medical subject headings: Lactose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fermented infant milk formulaOther
Non-fermented infant milk formulaOther

Study groups in NCT02703987
Study group	Role	What they receive
Group I	Experimental	Fermented infant milk formula Receives: Other: Fermented infant milk formula
Group II	Active comparator	Non-fermented infant milk formula Receives: Other: Non-fermented infant milk formula

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Jun 2016

First posted9 Mar 2016 (estimated)
Study startNov 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02703987
Sponsor's protocol ID: Dig.1.C.I/0
Acronym: HYBRID
Status last verified: Mar 2020
First submitted: 4 Mar 2016
Last updated: 18 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lactose Intolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02703987
Acronym / sponsor ID: HYBRID / Dig.1.C.I/0
Conditions: Lactose Intolerance
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 9 Mar 2016 (estimated)
Results: Posted 4 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group I	Experimental	Other: Fermented infant milk formulaFermented infant milk formula
Group II	Active comparator	Other: Non-fermented infant milk formulaNon-fermented infant milk formula

Who may qualify

Ages: 21 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

BMI between 18.5 and 24.9 kg/m2 inclusive Lactose intolerant
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.

Key exclusion criteria (5 listed)

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
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fermented infant milk formula	Other	Group I
Non-fermented infant milk formula	Other	Group II

Primary outcome

Log of First Postprandial Peak Change of Hydrogen Concentration
Time frame: 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
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
Log of Maximum Postprandial Change in Hydrogen Concentration
Time frame: 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
This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes

1 secondary outcome

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

Results and safety

Results posted to the registry on 4 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (Test at Visit 3 Followed by Control at Visit 4)	14	13
Sequence 2 (Control at Visit 3 Followed by Test at Visit 4)	14	11

Primary outcome: Log of First Postprandial Peak Change of Hydrogen Concentration

Time frame: 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. Least squares mean (Standard Error). Unit: log(ppm)

Measure	Control n = 27	Test n = 25
Baseline	1.21 (0.10)	1.10 (0.10)
Post-baseline	3.38 (0.08)	3.59 (0.09)

Control vs Test: Mean Difference (Net): 0.32 (95% CI -0.04 to 0.67), p = 0.0801, Mixed Models Analysis

Population analysed: At Visit 3, 14 subjects took the control product and at Visit 4, 13 subjects took the control product. Therefore, 27 subjects took the control product in total. At Visit 3, 14 subjects took the test product and at Visit 4, 11 subjects took the test product. Therefore, 25 subjects took the test product in total.

Primary outcome: Log of Maximum Postprandial Change in Hydrogen Concentration

Time frame: 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. Least squares mean (Standard Error). Unit: log(ppm)

Measure	Control n = 27	Test n = 25
Baseline	1.21 (0.10)	1.09 (0.11)
Post-baseline	3.70 (0.10)	3.93 (0.11)

Control vs Test: Mean Difference (Net): 0.34 (95% CI -0.03 to 0.71), p = 0.0714, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From visit 1 (day -14 to 0) to visit 4 (day 11 to 15). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 27 (0%)	26 of 27 (96.3%)	0 of 27
Test	0 of 25 (0%)	25 of 25 (100%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lactose Intolerance

Not yet recruiting
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ngai Moh Law principal investigator

Changi General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fermented infant milk formula and Non-fermented infant milk formula in people with Lactose Intolerance, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Log of First Postprandial Peak Change of Hydrogen Concentration (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02703987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.