Effects of Lactose on Fecal Microflora (ELM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599859
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : September 21, 2009
Danone Institute International
Information provided by:
Sir Mortimer B. Davis - Jewish General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Lactose Intolerance Dietary Supplement: lactose Not Applicable

Detailed Description:

Healthy volunteers between the ages of 18 and 49 are recruited.

  1. Each participant fills a lactose targetting diet questionnaire(3 day recall).
  2. A 50g lactose challenge tets is administered,breath hydrogen and symptoms are recorded for 4.5hrs.
  3. Blood is drawn for analysis of lactase genetic status.
  4. A stool sample is collected(10-15g)and analysed fo total anaerobes, enterococci, bifidobacteria and lactobacilli.
  5. 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.
  6. A voluntary segment has glucose and insulin measured for 4 hrs via an indwelling venous catheter.
  7. Subjects are asked to consume 50g lactose in divided doses for 2 further weeks
  8. At the end they return and repeat sections 2 and 4 for the third time.
  9. Participants who volunteered to have glucose and insulin measured repeat this segment of the study as well.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Differential Biologic Impact of Lactose Consumption in Lactase Persistent and Non-persistent Populations: Evaluation of Microflora and Insulin/Glycemic Response
Study Start Date : September 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
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.
Dietary Supplement: lactose
consumption of 50g lactose/day in 2 divided doses mixed in water.

Active Comparator: 2
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.
Dietary Supplement: lactose
consumption of lactose 50g/day in 2 divided doses mixed in water

Primary Outcome Measures :
  1. bacterial differences within the 2 groups between the 2 weeks of lactose ingestion [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. bacterial differences between the 2 groups on comparison of first stool sample [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18-49 yr old male or female.
  • Healthy except may take chronic thyroid or hypertension medication.

Exclusion Criteria:

  • Pregnancy
  • Antibiotics in last 6 weeks
  • Any active illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599859

Canada, Quebec
Sir Mortimer B Davis General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Danone Institute International
Principal Investigator: Andrew Szilagyi, MD SMBD Jewish General Hospital

Responsible Party: Andrew Szilagyi MD, SMBD Jewish General Hospital , McGill university Identifier: NCT00599859     History of Changes
Other Study ID Numbers: GIA-05-01
Danone Institute Mtl, Canada
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:

Additional relevant MeSH terms:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases