Clinical trial NCT01129791: Effects of Raw Versus Other Milk Sources on Lactose Digestion
Official title: Comparison of Raw Milk Consumption vs. Other Milk Sources on Lactose Digestion in Healthy Individuals With Self-reported Lactose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactose Intolerance
Keywords: Lactose intolerance
Dairy products
Raw milk
Adults
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.

Detailed description: The goal is to determine if raw milk consumption intake will benefit humans with lactose maldigestion, a common human response to the intake of dairy products during adult years. An increasing number of people are consuming raw unpasteurized milk. Enhanced nutritional qualities, taste, and health benefits have all been advocated as reasons for increased interest in raw milk consumption.

However, science-based data to substantiate these claims are limited or anecdotal.

Raw milk may differ in its ability to improve lactose maldigestion related symptoms from other milk types. Adult lactose maldigestion affects the majority of the world adult population. It appears that consumption of lactose containing foods by those who cannot digest lactose is a relatively common cause of irritable bowel syndrome.

Eligibility criteria: Inclusion Criteria:

* Gender: Both women and men
* Age: \> or = 18 years
* Ethnicity and race: All ethnic and racial backgrounds welcome
* Elevation of breath hydrogen after ingestion of 25 g of lactose \> 20 ppm over baseline
* Planning to be available for clinic visits for the 6 weeks of study participation
* Ability and willingness to give written informed consent
* No known active psychiatric illness.

Exclusion Criteria:

* Intake of antibiotics or other medications within the past month
* History of diarrheal illness within past month
* Secondary lactase deficiency
* Self reported personal history of:

  \*gastrointestinal conditions other than related with lactose maldigestion (IBS, IRB, Short bowel, malabsorption, celiac disease, GI surgery)
* Pregnant or Lactating
* Inability to communicate effectively with study personnel
* Protein allergy related to cow 's milk proteins or soybean proteins

Primary outcomes:
measure: Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8
timeFrame: Day 1 and day 8 of each milk phase
Secondary outcomes:
measure: Severity of symptoms of lactose intolerance for each milk phase
timeFrame: Day 7 of each milk phase
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Christopher D Gardner
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mummah S, Oelrich B, Hope J, Vu Q, Gardner CD. Effect of raw milk on lactose intolerance: a randomized controlled pilot study. Ann Fam Med. 2014 Mar-Apr;12(2):134-41. doi: 10.1370/afm.1618.