Effects of Lactose on Fecal Microflora

NCT00599859 | Completed DMC

• 2 other identifiers: GIA-05-01Danone Institute Mtl, Canada
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactose Intolerance

Keywords

lactase; lactose; microflora

Outcome Measures

Primary Outcomes (1)

• bacterial differences within the 2 groups between the 2 weeks of lactose ingestion

  2 weeks

Secondary Outcomes (1)

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

  1 day

Study Arms (2)

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.

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.

Dietary Supplement: lactose

Interventions

lactose DIETARY_SUPPLEMENT

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

1

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead
• Danone Institute International: collaborator

Study Sites (1)

Sir Mortimer B Davis General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (2)

• 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.

  PMID: 17044768 BACKGROUND

• Szilagyi 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.

  PMID: 17044769 BACKGROUND

MeSH Terms

Conditions

Lactose Intolerance

Interventions

Lactose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Andrew Szilagyi, MD

  SMBD Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 24, 2008
• Study Start: September 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 21, 2009

Record last verified: 2009-09

Locations

CA (1)