Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Pe… (NCT03713346) | Clinical Trial Compass
CompletedNot Applicable
Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons
United States42 participantsStarted 2018-01-17
Plain-language summary
Persons with dairy intolerance may experience cramps/abdominal pain, bloating, flatulence, acute diarrhea, or fecal urgency when they ingest excessive amounts of lactose. The intensity of these conditions can be mild or severe and likely depends on numerous variables including dose, transit time, intestinal residual lactase activity and microbiome potential to ferment lactose. Jersey cattle produce milk containing high levels of the A2 β-casein protein . There are claims that high A2 β-casein milk is more easily digested by people who are lactose maldigesters . We propose to conduct a double-blinded, randomized, controlled trial to determine if high A2 β-casein milk from Jersey cattle is actually better digested and tolerated by lactose maldigesters.
Who can participate
Age range18 Years – 65 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
✓. Ability/desire to provide informed consent
✓. Aged 18 to 65 years of age inclusive at screening
✓. Current or recent history of intolerance to and avoidance of milk of at least one month duration (by self-report and self-reported symptoms).
✓. Agrees to refrain from all other treatments and products used for lactose intolerance (e.g., Lactaid® Dietary Supplements) during study involvement
✓. Willing to return for all study visits and complete all study related procedures, including fasting before and during the hydrogen breath tests
✓. Qualifying Lactose Challenge Symptom Score:
✓. At least one score of "moderately severe" or "severe" on a single symptom during the 6 hour HBT test;
✓. A score of "moderate" or greater for a single symptom on at least two (2) time points during the 6 hour HBT test;
Exclusion criteria
✕
What they're measuring
1
Differences in AUC ΔH2 concentrations
Timeframe: Within the 6 hours following the milk challenge
✕. Cigarette smoking or other use of tobacco or nicotine containing products within 3 months of screening
✕. Diagnosed with any of the following disorders known to be associated with abnormal gastrointestinal motility such as; Gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
✕. History of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: gastrointestinal bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication, pyloroplasty \[Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded\]
✕. Past or present : Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), small intestine bacterial overgrowth syndrome (SIBO), gastroparesis, gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS) or any other medical condition with symptoms that could confound collection of adverse events.