Status:
UNKNOWN
Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance
Lead Sponsor:
Augusta University
Conditions:
Fructose Intolerance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Over the past few decades, fructose consumption has risen significantly in the United States1. This sugar is increasingly being used as a sweetener in a variety of foods1. Because there is a limited a...
Eligibility Criteria
Inclusion
- Diagnosis of fructose malabsorption (positive breath test after ingestion of 25 grams of fructose defined as either (a) ≥ 20 ppm rise of breath H2/CH4/both over baseline values or a successive rise of ≥ 5 ppm over baseline and in 3 consecutive breath samples)
- Women of childbearing potential must agree to a urine pregnancy test before supplement is dispensed and to avoid pregnancy throughout the study.
Exclusion
- Cognitive impairment or any other inability to provide informed consent
- Prisoners
- GI surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy
- Antibiotics in the previous 6 weeks.
- Major co-morbid illnesses, including chronic pancreatitis, celiac disease, inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc.
- Medication use: opioids, Tegaserod, laxatives, enemas
- Difficulty Swallowing
- Known food allergies or intolerance to any fiber supplements or other dietary nutritional supplements such as: Psyllium (Metamucil), Maltodextrin, Citric Acid, and methylcellulose (Citrucel).
Key Trial Info
Start Date :
January 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04022434
Start Date
January 7 2014
End Date
December 30 2020
Last Update
April 15 2020
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30912