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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8