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The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Fermented infant milk formula |
|
| Group II | Active Comparator | Non-fermented infant milk formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented infant milk formula | Other |
| ||
| Non-fermented infant milk formula |
| 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 |
| 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 |
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Inclusion Criteria:
BMI 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 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:
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| Name | Affiliation | Role |
|---|---|---|
| Ngai Moh Law | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | 529889 | Singapore |
Two subjects were terminated before randomisation (1 due to sponsor decision to withdraw, and 1 due to consent withdrawal).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 3 Intervention (1 Day) |
| |||||||||||||
| Washout (Minimum 5 Days) |
| |||||||||||||
| Visit 4 Intervention (1 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Test at visit 3, Control at visit 4 |
| BG001 | Sequence 2 | Control at visit 3, Test at visit 4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Least Squares Mean | Standard Error | log(ppm) | 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 |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Non-fermented infant milk formula | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danone Nutricia Research | Danone Nutricia Research | register.clinicalresearchnutricia@danone.com |
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| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Other |
|
| 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 |
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|
| NOT COMPLETED |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Non-fermented infant milk formula
| OG001 | Test | Fermented infant milk formula |
|
|
|
| Primary | 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 | 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. | Posted | Least Squares Mean | Standard Error | log(ppm) | 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 | 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 | 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. | Posted | Least Squares Mean | Standard Error | sqrt(ppm*min) | 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 |
|
|
|
|
| 27 |
| 0 |
| 27 |
| 26 |
| 27 |
| EG001 | Test | Fermented infant milk formula | 0 | 25 | 0 | 25 | 25 | 25 |
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
|
| Defecation Urgency | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Sounds Abnormal | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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.
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |