Raw Data from Clinical Trial NCT02692495
Description
Laboratory data of internationally-recruited volunteers with idiopathic malodor that participated in the Internet-based self-selection trial registered as NCT02692495 at clinicaltrials.gov
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Intestinal Permeability: The patient should fast for 3 hours before starting the test. Water intake during the first 2 hours of the 6 hour urine collection should be limited to 250 mL. Water consumption during the remainder of the test should be moderate. The patient should not take medicine containing Movicol (Macrogol), Mannitol, Sorbitol and Xylitos. Beer (including Guinness) and various soft drinks may also contain similar interfering substances. The sample is a 6 hour urine collection after a 3 gram oral dose of PEG 400. A 20 mL aliquot of urine may be sent for analysis if the volume of the total collection can be accurately measured. Extraction of PEG from urine is by ion exchange chromatography, using the procedure described by Sivakumaran et al (1982) Glucose challenge test: No food for 3 hours and no alcoholic beverages or food containing alcohol for 24 hours prior to the test. The patient is given 1 gram of glucose in hardened gelatine capsules (2 x 500mg capsules), together with 4 grams of glucose dissolved in 80-100ml of water. A blood sample is taken one hour laterBlood alcohols (ethanol, methanol, butanol, propanol and short chain fatty acids) are measured by gas-liquid chromatography. D-lactate is measured in blood plasma by centrifugal analysis using the specific enzyme D-lactate dehydrogenase, which does not react with L-lactate Indican is measured in early morning urine based on the color change. The presence of indican depends upon its decomposition and subsequent oxidation of indoxyl to indigo blue and its absorption into a chloroform layer. Levels of vitamins B1, B2 and B6 are measured in blood by the change in enzyme activity: erythrocyte transketolase[ETK], glutathione reductase [EGR] and glutamic-oxalocetic transaminase [EGOT] ,respectively, before and after the addition of excess vitamin. For the lactulose breath test the patient is given 10 gm of lactulose syrup with 200 ml of water; alveolar air samples are collected at baseline and then every 20 minutes for 3 hours (a total of 10 samples). No food and no alcohol should be consumed for 12 hours prior to the test, with only water to drink. Slowly digesting foods such as beans should be avoided on the day before the test. Recent antibiotic therapy may interfere with the results. Breath hydrogen and methane are measured in alveolar breath samples by gas-liquid chromatography.