Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2025-12-17 @ 2:31 AM
Study NCT ID:
NCT06177938
Status:
None
Last Update Posted:
2025-07-08 00:00:00
First Post:
2023-12-11 00:00:00
Brief Title:
Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers
Sponsor:
ETH Zurich
Organization:
ETH Zurich
Study Overview
Official Title:
Lactobreath: A Pilot Study to Diagnose Lactose Intolerance Based on the Exhaled Breath Metabolome
Status:
None
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lactobreath
Brief Summary:
Genetic and lactose tolerance screening For all eligible participants, a screening home test will be conducted. The home screening test kit will contain lactose powder and accompanying information in order for the subjects to conduct a lactose tolerance test (according to the LHBT protocol) at home. The test will be adapted from recent guidelines (https://www.esnm.eu/guidelines.html) that propose the use of 25g of lactose for lactose tolerance testing, including a questionnaire to quantitatively assess symptoms. The home screening test kit will also provide material to collect a saliva sample to determine genetic polymorphisms commonly modulating LP.
A total of 120 participants will be selected and distributed into three groups based on their LP genetic profiles and response to the ingestion of 25 g of lactose (lactose solution):
* 24 genetically LP subjects with no GI symptoms in response to the ingestion of lactose (group 1)
* 24 genetically lactase-non-persistent (LNP) subjects with no GI symptoms in response to the ingestion of lactose (group 2)
* 72 genetically LNP subjects with any GI symptoms in response to lactose ingestion (group 3).
Study procedures Baseline measures: For each subject, baseline measurement of microbiota and diet will be made within four weeks of the intervention day. The assessment of diet and the genomic characterization of the fecal microbiota will be performed in parallel with repeated measures
* Four 24 h dietary recalls will be completed using an adapted version of the myfood24 online platform on four consecutive days, during days -30 to -7, before the intervention day
* Three fecal samples will be collected by the participants at home, ideally on three consecutive days, on days +1, +2, and +3 relative to the first 24 h dietary recall.
Intervention day: The diet of all selected participants will be restricted for the three days before the carbohydrate challenge test day to ensure that all FODMAPs are avoided with a standardized diet provided to the participants for the three days before the test.
On the morning of the test day, the participants will be asked to collect their first test sample, the morning urine and consume 300 mL of water at home. Upon arrival in the test laboratory, the participants will deliver a further urine sample and baseline breath samples for the breath metabolome and hydrogen breath test. The urine samples will be used for metabolomics analysis and, in the case of female participants, for a pregnancy test. Participants with a positive pregnancy test will be excluded.
The participants will also fill out the questionnaire on LI (as used for the screening survey) to describe symptoms of LI before the test (baseline symptoms).
The 120 participants will be assigned to one of the two carbohydrate challenges using stratified randomization based on the three groups defined by the pre-screening tests. 100 participants will be assigned to the experimental intervention (lactose). The remaining 20 participants (4 participants from each groups 1 and 2 and 12 participants from group 3) will be assigned to the control intervention (glucose). The participants and investigators will be blinded during testing to the type of carbohydrate solution assigned.
For each participant, the carbohydrate solution will need to be consumed in a time-lapse of 5 min. Following the solution intake, participants will be asked to rinse their mouths with a standard quantity of water (500 mL) to avoid the detection of solution-relevant residual molecules in the oral cavity. The participants will swallow a commercially available gas-sensing capsule within the 5 minutes following the lactose or glucose solution intake to monitor intestinal gases and GI transit time.
Postprandial breath, exhaled breath condensate (EBC) and urine samples will then be collected at predefined times during the 6 h following consumption of the assigned test product. Breath sampling will be performed using a secondary electrospray ionization source coupled to a high-resolution mass spectrometry system (SESI-HR-MS) for direct and real-time detection of volatile organic compounds (VOC) and using an H2 breath sensor (e.g. QuinTron BreathTracker Digital Microlyzer) for detection of exhaled hydrogen. EBC samples will be collected using a spirometry filter connected to a glass cold trap cooled to -78°C. In addition, the participants will fill out the questionnaire for symptoms of LI to describe the symptoms during the 6 h postprandial assessment .
To normalize participants' hydration, particularly to facilitate the urine collection, the participants will be offered a standardized quantity of water based on their body weight to be consumed in regular portions during the post-ingestion period. No other foods or fluids will be permitted during the laboratory testing.
Intestinal excretion of the gas-sensing capsule will mark the end of the intervention. A follow-up visit to confirm the excretion of the gas-sensing capsule will conclude the study.
Additional subjects will be recruited should the number of participants completing the lactose and glucose tests fall below the targeted numbers.
A total of 120 participants will be selected and distributed into three groups based on their LP genetic profiles and response to the ingestion of 25 g of lactose (lactose solution):
* 24 genetically LP subjects with no GI symptoms in response to the ingestion of lactose (group 1)
* 24 genetically lactase-non-persistent (LNP) subjects with no GI symptoms in response to the ingestion of lactose (group 2)
* 72 genetically LNP subjects with any GI symptoms in response to lactose ingestion (group 3).
Study procedures Baseline measures: For each subject, baseline measurement of microbiota and diet will be made within four weeks of the intervention day. The assessment of diet and the genomic characterization of the fecal microbiota will be performed in parallel with repeated measures
* Four 24 h dietary recalls will be completed using an adapted version of the myfood24 online platform on four consecutive days, during days -30 to -7, before the intervention day
* Three fecal samples will be collected by the participants at home, ideally on three consecutive days, on days +1, +2, and +3 relative to the first 24 h dietary recall.
Intervention day: The diet of all selected participants will be restricted for the three days before the carbohydrate challenge test day to ensure that all FODMAPs are avoided with a standardized diet provided to the participants for the three days before the test.
On the morning of the test day, the participants will be asked to collect their first test sample, the morning urine and consume 300 mL of water at home. Upon arrival in the test laboratory, the participants will deliver a further urine sample and baseline breath samples for the breath metabolome and hydrogen breath test. The urine samples will be used for metabolomics analysis and, in the case of female participants, for a pregnancy test. Participants with a positive pregnancy test will be excluded.
The participants will also fill out the questionnaire on LI (as used for the screening survey) to describe symptoms of LI before the test (baseline symptoms).
The 120 participants will be assigned to one of the two carbohydrate challenges using stratified randomization based on the three groups defined by the pre-screening tests. 100 participants will be assigned to the experimental intervention (lactose). The remaining 20 participants (4 participants from each groups 1 and 2 and 12 participants from group 3) will be assigned to the control intervention (glucose). The participants and investigators will be blinded during testing to the type of carbohydrate solution assigned.
For each participant, the carbohydrate solution will need to be consumed in a time-lapse of 5 min. Following the solution intake, participants will be asked to rinse their mouths with a standard quantity of water (500 mL) to avoid the detection of solution-relevant residual molecules in the oral cavity. The participants will swallow a commercially available gas-sensing capsule within the 5 minutes following the lactose or glucose solution intake to monitor intestinal gases and GI transit time.
Postprandial breath, exhaled breath condensate (EBC) and urine samples will then be collected at predefined times during the 6 h following consumption of the assigned test product. Breath sampling will be performed using a secondary electrospray ionization source coupled to a high-resolution mass spectrometry system (SESI-HR-MS) for direct and real-time detection of volatile organic compounds (VOC) and using an H2 breath sensor (e.g. QuinTron BreathTracker Digital Microlyzer) for detection of exhaled hydrogen. EBC samples will be collected using a spirometry filter connected to a glass cold trap cooled to -78°C. In addition, the participants will fill out the questionnaire for symptoms of LI to describe the symptoms during the 6 h postprandial assessment .
To normalize participants' hydration, particularly to facilitate the urine collection, the participants will be offered a standardized quantity of water based on their body weight to be consumed in regular portions during the post-ingestion period. No other foods or fluids will be permitted during the laboratory testing.
Intestinal excretion of the gas-sensing capsule will mark the end of the intervention. A follow-up visit to confirm the excretion of the gas-sensing capsule will conclude the study.
Additional subjects will be recruited should the number of participants completing the lactose and glucose tests fall below the targeted numbers.
Detailed Description:
Genetic and lactose tolerance screening For all eligible participants a screening home test will be conducted The home screening test kit will contain lactose powder and accompanying information in order for the subjects to conduct a lactose tolerance test according to the LHBT protocol at home The test will be adapted from recent guidelines httpswwwesnmeuguidelineshtml that propose the use of 25g of lactose for lactose tolerance testing including a questionnaire to quantitatively assess symptoms The home screening test kit will also provide material to collect a saliva sample to determine genetic polymorphisms commonly modulating LP
A total of 120 participants will be selected and distributed into three groups based on their LP genetic profiles and response to the ingestion of 25 g of lactose lactose solution
24 genetically LP subjects with no GI symptoms in response to the ingestion of lactose group 1
24 genetically lactase-non-persistent LNP subjects with no GI symptoms in response to the ingestion of lactose group 2
72 genetically LNP subjects with any GI symptoms in response to lactose ingestion group 3
Study procedures Baseline measures For each subject baseline measurement of microbiota and diet will be made within four weeks of the intervention day The assessment of diet and the genomic characterization of the fecal microbiota will be performed in parallel with repeated measures
Four 24 h dietary recalls will be completed using an adapted version of the myfood24 online platform on four consecutive days during days -30 to -7 before the intervention day
Three fecal samples will be collected by the participants at home ideally on three consecutive days on days 1 2 and 3 relative to the first 24 h dietary recall
Intervention day The diet of all selected participants will be restricted for the three days before the carbohydrate challenge test day to ensure that all FODMAPs are avoided with a standardized diet provided to the participants for the three days before the test
On the morning of the test day the participants will be asked to collect their first test sample the morning urine and consume 300 mL of water at home Upon arrival in the test laboratory the participants will deliver a further urine sample and baseline breath samples for the breath metabolome and hydrogen breath test The urine samples will be used for metabolomics analysis and in the case of female participants for a pregnancy test Participants with a positive pregnancy test will be excluded
The participants will also fill out the questionnaire on LI as used for the screening survey to describe symptoms of LI before the test baseline symptoms
The 120 participants will be assigned to one of the two carbohydrate challenges using stratified randomization based on the three groups defined by the pre-screening tests 100 participants will be assigned to the experimental intervention lactose The remaining 20 participants 4 participants from each groups 1 and 2 and 12 participants from group 3 will be assigned to the control intervention glucose The participants and investigators will be blinded during testing to the type of carbohydrate solution assigned
For each participant the carbohydrate solution will need to be consumed in a time-lapse of 5 min Following the solution intake participants will be asked to rinse their mouths with a standard quantity of water 500 mL to avoid the detection of solution-relevant residual molecules in the oral cavity The participants will swallow a commercially available gas-sensing capsule within the 5 minutes following the lactose or glucose solution intake to monitor intestinal gases and GI transit time
Postprandial breath exhaled breath condensate EBC and urine samples will then be collected at predefined times during the 6 h following consumption of the assigned test product Breath sampling will be performed using a secondary electrospray ionization source coupled to a high-resolution mass spectrometry system SESI-HR-MS for direct and real-time detection of volatile organic compounds VOC and using an H2 breath sensor eg QuinTron BreathTracker Digital Microlyzer for detection of exhaled hydrogen EBC samples will be collected using a spirometry filter connected to a glass cold trap cooled to -78C In addition the participants will fill out the questionnaire for symptoms of LI to describe the symptoms during the 6 h postprandial assessment
To normalize participants hydration particularly to facilitate the urine collection the participants will be offered a standardized quantity of water based on their body weight to be consumed in regular portions during the post-ingestion period No other foods or fluids will be permitted during the laboratory testing
Intestinal excretion of the gas-sensing capsule will mark the end of the intervention A follow-up visit to confirm the excretion of the gas-sensing capsule will conclude the study
Additional subjects will be recruited should the number of participants completing the lactose and glucose tests fall below the targeted numbers
A total of 120 participants will be selected and distributed into three groups based on their LP genetic profiles and response to the ingestion of 25 g of lactose lactose solution
24 genetically LP subjects with no GI symptoms in response to the ingestion of lactose group 1
24 genetically lactase-non-persistent LNP subjects with no GI symptoms in response to the ingestion of lactose group 2
72 genetically LNP subjects with any GI symptoms in response to lactose ingestion group 3
Study procedures Baseline measures For each subject baseline measurement of microbiota and diet will be made within four weeks of the intervention day The assessment of diet and the genomic characterization of the fecal microbiota will be performed in parallel with repeated measures
Four 24 h dietary recalls will be completed using an adapted version of the myfood24 online platform on four consecutive days during days -30 to -7 before the intervention day
Three fecal samples will be collected by the participants at home ideally on three consecutive days on days 1 2 and 3 relative to the first 24 h dietary recall
Intervention day The diet of all selected participants will be restricted for the three days before the carbohydrate challenge test day to ensure that all FODMAPs are avoided with a standardized diet provided to the participants for the three days before the test
On the morning of the test day the participants will be asked to collect their first test sample the morning urine and consume 300 mL of water at home Upon arrival in the test laboratory the participants will deliver a further urine sample and baseline breath samples for the breath metabolome and hydrogen breath test The urine samples will be used for metabolomics analysis and in the case of female participants for a pregnancy test Participants with a positive pregnancy test will be excluded
The participants will also fill out the questionnaire on LI as used for the screening survey to describe symptoms of LI before the test baseline symptoms
The 120 participants will be assigned to one of the two carbohydrate challenges using stratified randomization based on the three groups defined by the pre-screening tests 100 participants will be assigned to the experimental intervention lactose The remaining 20 participants 4 participants from each groups 1 and 2 and 12 participants from group 3 will be assigned to the control intervention glucose The participants and investigators will be blinded during testing to the type of carbohydrate solution assigned
For each participant the carbohydrate solution will need to be consumed in a time-lapse of 5 min Following the solution intake participants will be asked to rinse their mouths with a standard quantity of water 500 mL to avoid the detection of solution-relevant residual molecules in the oral cavity The participants will swallow a commercially available gas-sensing capsule within the 5 minutes following the lactose or glucose solution intake to monitor intestinal gases and GI transit time
Postprandial breath exhaled breath condensate EBC and urine samples will then be collected at predefined times during the 6 h following consumption of the assigned test product Breath sampling will be performed using a secondary electrospray ionization source coupled to a high-resolution mass spectrometry system SESI-HR-MS for direct and real-time detection of volatile organic compounds VOC and using an H2 breath sensor eg QuinTron BreathTracker Digital Microlyzer for detection of exhaled hydrogen EBC samples will be collected using a spirometry filter connected to a glass cold trap cooled to -78C In addition the participants will fill out the questionnaire for symptoms of LI to describe the symptoms during the 6 h postprandial assessment
To normalize participants hydration particularly to facilitate the urine collection the participants will be offered a standardized quantity of water based on their body weight to be consumed in regular portions during the post-ingestion period No other foods or fluids will be permitted during the laboratory testing
Intestinal excretion of the gas-sensing capsule will mark the end of the intervention A follow-up visit to confirm the excretion of the gas-sensing capsule will conclude the study
Additional subjects will be recruited should the number of participants completing the lactose and glucose tests fall below the targeted numbers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None