Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT04022434
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04022434
Study Brief:
Protocol Section:
NCT04022434