Trial Outcomes & Findings for HYBRID: Hydrogen Breath Test in Lactose Digestion (NCT NCT02703987)
NCT ID: NCT02703987
Last Updated: 2020-03-18
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
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
Results posted on
2020-03-18
Participant Flow
Two subjects were terminated before randomisation (1 due to sponsor decision to withdraw, and 1 due to consent withdrawal).
Participant milestones
| Measure |
Sequence 1 (Test at Visit 3 Followed by Control at Visit 4)
Test product: 35g of Gallia Lactofidus 1 + 11.2g lactose to match an oral load of 20g lactose, 250mL (reconstituted), once as breakfast, had to be consumed within 10 mins
Control product: 35g of Nursie 1 + 10g maltodextrin to match an oral load of 20g lactose and the carbohydrate load as test product, 250mL (reconstituted), once as breakfast, had to be consumed within 10 mins.
|
Sequence 2 (Control at Visit 3 Followed by Test at Visit 4)
Control product: 35g of Nursie 1 + 10g maltodextrin to match an oral load of 20g lactose and the carbohydrate load as test product, 250mL (reconstituted), once as breakfast, had to be consumed within 10
Test product: 35g of Gallia Lactofidus 1 + 11.2g lactose to match an oral load of 20g lactose, 250mL (reconstituted), once as breakfast, had to be consumed within 10 mins
|
|---|---|---|
|
Visit 3 Intervention (1 Day)
STARTED
|
14
|
14
|
|
Visit 3 Intervention (1 Day)
COMPLETED
|
13
|
11
|
|
Visit 3 Intervention (1 Day)
NOT COMPLETED
|
1
|
3
|
|
Washout (Minimum 5 Days)
STARTED
|
13
|
11
|
|
Washout (Minimum 5 Days)
COMPLETED
|
13
|
11
|
|
Washout (Minimum 5 Days)
NOT COMPLETED
|
0
|
0
|
|
Visit 4 Intervention (1 Day)
STARTED
|
13
|
11
|
|
Visit 4 Intervention (1 Day)
COMPLETED
|
12
|
10
|
|
Visit 4 Intervention (1 Day)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HYBRID: Hydrogen Breath Test in Lactose Digestion
Baseline characteristics by cohort
| Measure |
Sequence 1
n=14 Participants
Test at visit 3, Control at visit 4
|
Sequence 2
n=14 Participants
Control at visit 3, Test at visit 4
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Malay
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 4Population: 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.
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
Outcome measures
| Measure |
Control
n=27 Participants
Non-fermented infant milk formula
|
Test
n=25 Participants
Fermented infant milk formula
|
|---|---|---|
|
Log of First Postprandial Peak Change of Hydrogen Concentration
Baseline
|
1.21 log(ppm)
Standard Error 0.10
|
1.10 log(ppm)
Standard Error 0.10
|
|
Log of First Postprandial Peak Change of Hydrogen Concentration
Post-baseline
|
3.38 log(ppm)
Standard Error 0.08
|
3.59 log(ppm)
Standard Error 0.09
|
PRIMARY outcome
Timeframe: 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 4Population: 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.
This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes
Outcome measures
| Measure |
Control
n=27 Participants
Non-fermented infant milk formula
|
Test
n=25 Participants
Fermented infant milk formula
|
|---|---|---|
|
Log of Maximum Postprandial Change in Hydrogen Concentration
Baseline
|
1.21 log(ppm)
Standard Error 0.10
|
1.09 log(ppm)
Standard Error 0.11
|
|
Log of Maximum Postprandial Change in Hydrogen Concentration
Post-baseline
|
3.70 log(ppm)
Standard Error 0.10
|
3.93 log(ppm)
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 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 4Population: 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.
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
Outcome measures
| Measure |
Control
n=27 Participants
Non-fermented infant milk formula
|
Test
n=25 Participants
Fermented infant milk formula
|
|---|---|---|
|
Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes
|
66.22 sqrt(ppm*min)
Standard Error 4.42
|
75.78 sqrt(ppm*min)
Standard Error 4.59
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Test
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=27 participants at risk
Non-fermented infant milk formula
|
Test
n=25 participants at risk
Fermented infant milk formula
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/27 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
4.0%
1/25 • Number of events 1 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Abdominal Distension
|
14.8%
4/27 • Number of events 4 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
20.0%
5/25 • Number of events 5 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.8%
4/27 • Number of events 4 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
4.0%
1/25 • Number of events 1 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/27 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
4.0%
1/25 • Number of events 1 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Defecation Urgency
|
3.7%
1/27 • Number of events 1 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
4.0%
1/25 • Number of events 1 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Diarrhoea
|
51.9%
14/27 • Number of events 14 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
56.0%
14/25 • Number of events 14 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
12.0%
3/25 • Number of events 4 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Eructation
|
3.7%
1/27 • Number of events 1 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
0.00%
0/25 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Flatulence
|
55.6%
15/27 • Number of events 16 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
64.0%
16/25 • Number of events 16 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Gastrointestinal Sounds Abnormal
|
33.3%
9/27 • Number of events 9 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
16.0%
4/25 • Number of events 4 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
|
Gastrointestinal disorders
Nausea
|
14.8%
4/27 • Number of events 4 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
20.0%
5/25 • Number of events 5 • From visit 1 (day -14 to 0) to visit 4 (day 11 to 15)
Adverse events were collected throughout the study period and were documented by Investigator at Visit 2 (Day 1), Visit 3 (Day 6-8), and Visit 4 (Day 11-15).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results communication be submitted to Nutricia Research for review and comment prior to publication at least sixty (60) days prior to submission for publication, public dissemination, or review by a publication committee. All reasonable comments made by Nutricia Research in relation to a proposed publication by Contractor will be incorporated into the publication.
- Publication restrictions are in place
Restriction type: OTHER