Effects of Raw Versus Other Milk Sources on Lactose Digestion (NCT01129791) | Clinical Trial Compass
CompletedNot Applicable
Effects of Raw Versus Other Milk Sources on Lactose Digestion
United States16 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8