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Completed

NCT Number: NCT00599859

Effects of Lactose on Fecal Microflora

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.

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Key information

Conditions

Lactose Intolerance Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Mortimer B Davis General Hospital

Montreal, Quebec, H3T 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactose

Dietary Supplement

consumption of 50g lactose/day in 2 divided doses mixed in water.

Primary outcomes

  1. bacterial differences within the 2 groups between the 2 weeks of lactose ingestion

    Time frame: 2 weeks

Secondary outcomes

  1. bacterial differences between the 2 groups on comparison of first stool sample

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Collaborators

  • Danone Institute International

Registry information

Official study title

Differential Biologic Impact of Lactose Consumption in Lactase Persistent and Non-persistent Populations: Evaluation of Microflora and Insulin/Glycemic Response

Acronym: ELM

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 24, 2008
Registry last updated
Sep 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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