An interventional study of Fermented infant milk formula and Non-fermented infant milk formula in Lactose Intolerance, sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Completed at 1 site in Singapore. Open to male participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Danone Asia Pacific Holdings Pte, Ltd. (part of Danone) · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 30 is below the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
between 18.5 and 24.9 kg/m2 inclusive Lactose intolerant
The following criteria need to be checked at visit 2:
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 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fermented infant milk formula
Other: Fermented infant milk formula
Non-fermented infant milk formula
Other: Non-fermented infant milk formula
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
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
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
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
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
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
| Milestone | Sequence 1 (Test at Visit 3 Followed by Control at Visit 4) | Sequence 2 (Control at Visit 3 Followed by Test at Visit 4) |
|---|---|---|
| Started | 14 | 14 |
| Completed | 13 | 11 |
| Not completed | 1 | 3 |
| Milestone | Sequence 1 (Test at Visit 3 Followed by Control at Visit 4) | Sequence 2 (Control at Visit 3 Followed by Test at Visit 4) |
|---|---|---|
| Started | 13 | 11 |
| Completed | 13 | 11 |
| Not completed | 0 | 0 |
| Milestone | Sequence 1 (Test at Visit 3 Followed by Control at Visit 4) | Sequence 2 (Control at Visit 3 Followed by Test at Visit 4) |
|---|---|---|
| Started | 13 | 11 |
| Completed | 12 | 10 |
| Not completed | 1 | 1 |
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(ppm) | Control | Test |
|---|---|---|
| Baseline | 1.21 ± 0.10 | 1.10 ± 0.10 |
| Post-baseline | 3.38 ± 0.08 | 3.59 ± 0.09 |
This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes
| log(ppm) | Control | Test |
|---|---|---|
| Baseline | 1.21 ± 0.10 | 1.09 ± 0.11 |
| Post-baseline | 3.70 ± 0.10 | 3.93 ± 0.11 |
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
| sqrt(ppm*min) | Control | Test |
|---|---|---|
| Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes | 66.22 ± 4.42 | 75.78 ± 4.59 |
Collected over From visit 1 (day -14 to 0) to visit 4 (day 11 to 15). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/27 (0%) | 0/27 (0%) | 26/27 (96.3%) |
| Test | 0/25 (0%) | 0/25 (0%) | 25/25 (100%) |
| Event | Control | Test |
|---|---|---|
| FlatulenceGastrointestinal disorders | 15/27 | 16/25 |
| DiarrhoeaGastrointestinal disorders | 14/27 | 14/25 |
| Gastrointestinal Sounds AbnormalGastrointestinal disorders | 9/27 | 4/25 |
| Abdominal DistensionGastrointestinal disorders | 4/27 | 5/25 |
| NauseaGastrointestinal disorders | 4/27 | 5/25 |
| Abdominal PainGastrointestinal disorders | 4/27 | 1/25 |
| DyspepsiaGastrointestinal disorders | 0/27 | 3/25 |
| Abdominal DiscomfortGastrointestinal disorders | 0/27 | 1/25 |
| Abdominal Pain UpperGastrointestinal disorders | 0/27 | 1/25 |
| Defecation UrgencyGastrointestinal disorders | 1/27 | 1/25 |
| Age, Continuous(years) | Sequence 1 | Sequence 2 | Total |
|---|---|---|---|
| Mean | 30.0 ± 6.5 | 30.6 ± 4.6 | 30.3 ± 5.6 |
| Sex: Female, Male(Participants) | Sequence 1 | Sequence 2 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 14 | 14 | 28 |
| Race/Ethnicity, Customized(Participants) | Sequence 1 | Sequence 2 | Total |
|---|---|---|---|
| Chinese | 13 | 12 | 25 |
| Indian | 0 | 1 | 1 |
| Malay | 0 | 1 | 1 |
| Other | 1 | 0 | 1 |
The record gives a start of Nov 2015, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2020, 3 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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