Lactose IntoleranceELMNCT00599859
Effects of Lactose on Fecal Microflora
A study testing lactose in people with Lactose Intolerance, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial summary
The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those who cannot(LNP)digest lactose. This division may help modify disease risks according to geographic population distribution. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- lactose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-49 yr old male or female.
- Healthy except may take chronic thyroid or hypertension medication.
Who cannot join
- Pregnancy
- Antibiotics in last 6 weeks
- Any active illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Biologic Impact of Lactose Consumption in Lactase Persistent and Non-persistent Populations: Evaluation of Microflora and Insulin/Glycemic Response
The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those who cannot(LNP)digest lactose. This division may help modify disease risks according to geographic population distribution. At least some of the putative mechanism of risk modification may relate to an effect of undigested lactose on lower intestinal bacteria. The effect may provide for support of beneficial microbes. The amount of lactose reaching the colon is made easier in LNP than LP subjects who have to consume larger amounts to have meaningful spillover into the lower bowel.The current study examines whether there are quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk sugar)between these 2 different phenotypic populations. Finding of differences would lend support to the notion that for some diseases LP and LNP subjects face different risks even in an area of uniform disease risk if they consume lactose (found in dairy foods).
The primary end point is comparison of 4 groups of specific bacteria between LP and LNP participants before and after 2 weeks of lactose(in powder form mixed in water) consumption. Classification is based on genetic analysis and secondarily on breath hydrogen results. Results are compared within groups.
Read more
The secondary outcome is comparison of 4 groups of bacteria between LP and LNP subjects against each group of stool samples obtained on the first visit. Results are obtained between groups.
Additional information and other secondary outcomes are to evaluate any relationship between diet intake and the 4 groups of bacteria on the first visit
Another outcome will be to compare within groups any effect of lactose consumption on insulin and glucose levels within the 2 groups.
Read the detailed description
Healthy volunteers between the ages of 18 and 49 are recruited.
- Each participant fills a lactose targetting diet questionnaire(3 day recall).
- A 50g lactose challenge tets is administered,breath hydrogen and symptoms are recorded for 4.5hrs.
- Blood is drawn for analysis of lactase genetic status.
- A stool sample is collected(10-15g)and analysed fo total anaerobes, enterococci, bifidobacteria and lactobacilli.
- All subjects are withdrawn from dairy foods(calcium replacement suggested in diet) for 2 weeks and are aked to return to repeat parts 2 and 4.
- A voluntary segment has glucose and insulin measured for 4 hrs via an indwelling venous catheter.
- Subjects are asked to consume 50g lactose in divided doses for 2 further weeks
- At the end they return and repeat sections 2 and 4 for the third time.
- Participants who volunteered to have glucose and insulin measured repeat this segment of the study as well.
- Conditions
- Lactose Intolerance
- Being tested
- lactose
- Keywords
- lactase, lactose, microflora
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactoseDietary supplement
consumption of 50g lactose/day in 2 divided doses mixed in water.
lactoseDietary supplement
consumption of lactose 50g/day in 2 divided doses mixed in water
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants in arm 1 are grouped as lactose digesters based on genetic analysis and breath hydrogen results. In discrepant cases the genetic status is accepted. Arm 1 is initially withdrawn from dairy foods(lactose) and then asked to consume lactose 50g in divided doses mixed in water for 2 weeks. Receives: Dietary Supplement: lactose |
| 2 | Active comparator | Arm 2 are lactose maldigesters: 2 interventions are a. withdrawal from lactose for 2 weeks and b. consumption of 50g lactose in divided doses mixed in water for a 2 week period. Receives: Dietary Supplement: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial differences within the 2 groups between the 2 weeks of lactose ingestion
Measured: 2 weeks
Secondary outcomes (1)
bacterial differences between the 2 groups on comparison of first stool sample
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute International
- Investigators
- Andrew Szilagyi, MD, Principal investigator, SMBD Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599859
- Sponsor's protocol ID
- GIA-05-01
- Other IDs
- Danone Institute Mtl, Canada
- Acronym
- ELM
- Status last verified
- Sep 2009
- First submitted
- 10 Jan 2008
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szilagyi A, Nathwani U, Vinokuroff C, Correa JA, Shrier I. The effect of lactose maldigestion on the relationship between dairy food intake and colorectal cancer: a systematic review. Nutr Cancer. 2006;55(2):141-50. doi: 10.1207/s15327914nc5502_4.
PubMed 17044768Szilagyi A, Nathwani U, Vinokuroff C, Correa JA, Shrier I. Evaluation of relationships among national colorectal cancer mortality rates, genetic lactase non-persistence status, and per capita yearly milk and milk product consumption. Nutr Cancer. 2006;55(2):151-6. doi: 10.1207/s15327914nc5502_5.
PubMed 17044769
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Biologic Impact of Lactose Consumption in Lactase Persistent and Non-persistent Populations: Evaluation of Microflora and Insulin/Glycemic Response
- ClinicalTrials.gov ID
- NCT00599859
- Acronym / sponsor ID
- ELM / GIA-05-01
- Conditions
- Lactose Intolerance
- Keywords
- lactase, lactose, microflora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Danone Institute International
- Study start
- Sep 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those who cannot(LNP)digest lactose. This division may help modify disease risks according to geographic population distribution. At least some of the putative mechanism of risk modification may relate to an effect of undigested lactose on lower intestinal bacteria. The effect may provide for support of beneficial microbes. The amount of lactose reaching the colon is made easier in LNP than LP subjects who have to consume larger amounts to have meaningful spillover into the lower bowel.The current study examines whether there are quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk sugar)between these 2 different phenotypic populations. Finding of differences would lend support to the notion that for some diseases LP and LNP subjects face different risks even in an area of uniform disease risk if they consume lactose (found in dairy foods).
The primary end point is comparison of 4 groups of specific bacteria between LP and LNP participants before and after 2 weeks of lactose(in powder form mixed in water) consumption. Classification is based on genetic analysis and secondarily on breath hydrogen results. Results are compared within groups.
The secondary outcome is comparison of 4 groups of bacteria between LP and LNP subjects against each group of stool samples obtained on the first visit. Results are obtained between groups.
Additional information and other secondary outcomes are to evaluate any relationship between diet intake and the 4 groups of bacteria on the first visit
Another outcome will be to compare within groups any effect of lactose consumption on insulin and glucose levels within the 2 groups.
Detailed description
Healthy volunteers between the ages of 18 and 49 are recruited.
- Each participant fills a lactose targetting diet questionnaire(3 day recall).
- A 50g lactose challenge tets is administered,breath hydrogen and symptoms are recorded for 4.5hrs.
- Blood is drawn for analysis of lactase genetic status.
- A stool sample is collected(10-15g)and analysed fo total anaerobes, enterococci, bifidobacteria and lactobacilli.
- All subjects are withdrawn from dairy foods(calcium replacement suggested in diet) for 2 weeks and are aked to return to repeat parts 2 and 4.
- A voluntary segment has glucose and insulin measured for 4 hrs via an indwelling venous catheter.
- Subjects are asked to consume 50g lactose in divided doses for 2 further weeks
- At the end they return and repeat sections 2 and 4 for the third time.
- Participants who volunteered to have glucose and insulin measured repeat this segment of the study as well.
Study design
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: lactoseParticipants in arm 1 are grouped as lactose digesters based on genetic analysis and breath hydrogen results. In discrepant cases the genetic status is accepted. Arm 1 is initially withdrawn from dairy foods(lactose) and then asked to consume lactose 50g in divided doses mixed in water for 2 weeks. |
| 2 | Active comparator | Dietary Supplement: lactoseArm 2 are lactose maldigesters: 2 interventions are a. withdrawal from lactose for 2 weeks and b. consumption of 50g lactose in divided doses mixed in water for a 2 week period. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-49 yr old male or female.
- Healthy except may take chronic thyroid or hypertension medication.
Key exclusion criteria (3 listed)
- Pregnancy
- Antibiotics in last 6 weeks
- Any active illness.
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 |
|---|---|---|
| lactoseconsumption of 50g lactose/day in 2 divided doses mixed in water. | Dietary supplement | 1 |
| lactoseconsumption of lactose 50g/day in 2 divided doses mixed in water | Dietary supplement | 2 |
Primary outcome
bacterial differences within the 2 groups between the 2 weeks of lactose ingestion
Time frame: 2 weeks
1 secondary outcome
bacterial differences between the 2 groups on comparison of first stool sample
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
- Background: PubMed 17044768Szilagyi A, Nathwani U, Vinokuroff C, Correa JA, Shrier I. The effect of lactose maldigestion on the relationship between dairy food intake and colorectal cancer: a systematic review. Nutr Cancer. 2006;55(2):141-50. doi: 10.1207/s15327914nc5502_4.
- Background: PubMed 17044769Szilagyi A, Nathwani U, Vinokuroff C, Correa JA, Shrier I. Evaluation of relationships among national colorectal cancer mortality rates, genetic lactase non-persistence status, and per capita yearly milk and milk product consumption. Nutr Cancer. 2006;55(2):151-6. doi: 10.1207/s15327914nc5502_5.
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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.
Andrew Szilagyi, MD principal investigator
SMBD Jewish 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 lactose in people with Lactose Intolerance, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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 2 inclusion and 3 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 21 Sep 2009. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bacterial differences within the 2 groups between the 2 weeks of lactose ingestion (time frame: 2 weeks). 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 NCT00599859, which also lists 2 linked publications.
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 21 Sep 2009.