NCT02692495: Documentation of Clinical Trial Data and Procedures
Documentation of Clinical Trial Data and Procedures
Diagnostic tests:
Software tools:
- Gut Permeability Profile (using PEG 400 as a probe and measuring all urine passed for the following 6 hours at 11 different molecular weights to establish the quantity of each absorbed through the gut wall). [Refs]
- Gut Fermentation Profile (Blood alcohols - ethanol, methanol, butanol, propanol and short chain fatty acids - are measured by gas-liquid chromatography). [Refs]
- D-lactate test (D-lactate is measured by centrifugal analysis using the specific enzyme D-lactate dehydrogenase, which does not react with L-lactate) [Refs]
- The urine indicans (or Obermeyer) test (Detection of indican in the urine depends upon its decomposition and subsequent oxidation of indoxyl to indigo blue and its absorption into a chloroform layer) [Refs]
- Breath Hydrogen and Methane test; previously known as Breath test for small intestinal dysbiosis (Breath hydrogen and methane are measured by gas-liquid chromatography. The patient is given 10 gm of lactulose in 200 ml of water and alveolar air samples are collected every 20 minutes for 3 hours) [Refs]
- Functional B vitamins profile (see also functional blood profile), focus on Riboflavin (B2) - by measuring the activation of a red cell enzyme that is dependent upon an adequate concentration of a particular vitamin for full activity. The assay relies on normal metabolism of the vitamin to its native form and the presence of other non-vitamin co-factors. [Refs]
- Hair Element Analysis (Hair samples analyzed by inductively coupled plasma – mass spectrometry) [Refs]
- Amino Acid Profile (urine, 56 amino acids measured in umol/mmol creatinine) [Refs]
- Organic Acid Profile (urine)
- Glutathione-S-transferase (GST) test, serum
- Microbiome Analysis (stool, sweat, intraoral samples)
Software tools:
- Aurametrix Software (General Availability Announcement)
- R (k-means and hierarchical clustering, PCA, visualization)
- VBA Excel macros (PCA, PLS, t-tests)
Results and Discussions
MeBO blog posts: discussing results, from 1 to 14; tabular summary of selected data as of autumn 2009
MeBO blog posts: discussing results, from 1 to 14; tabular summary of selected data as of autumn 2009
- T1 raw data: intestinal permeability profile; glucose challenge blood test; urine Indican and blood D-lactate
- T2 raw data: intestinal permeability profile, glucose challenge; Indican & D-lactate
- T3 raw data: gut permeability; glucose challenge; Indican & D-lactate, vitamin B2
- T4 raw data: gut permeability, glucose challenge; Indican and D-lactate
- T5 raw data: gut permeability; glucose challenge; Indican & D-lactate, Amino acids, Organic acids, additional, experience
- T6 raw data: gut permeability, glucose challenge; Indican & D-lactate
- T7 raw data: gut permeability, glucose challenge; Indican & D-lactate
- T8 raw data: gut permeability, glucose challenge; Indican & D-lactate; vitamin B2
- T9 raw data: gut permeability, glucose challenge; Indican & D-lactate; vitamin B2
- T10 raw data: gut permeability, glucose challenge; Indican & D-lactate; vitamin B2
- T11 raw data: gut permeability, glucose challenge; Indican & D-lactate; vitamin B2
- T12 raw data: gut permeability, glucose challenge; Indican & D-lactate; vitamin B2
- T13 raw data: gut permeability, glucose challenge; Indican
- T14 raw data: gut permeability, glucose challenge; Indican; vitamin B2
- T15 raw data: breath test, glucose challenge; Indican & D-lactate
- T16 raw data: gut permeability, glucose challenge; Indican, breath test
Downloadable Data and Manuscript
Gabashvili, Irene (2017), “Raw Data from Clinical Trial NCT02692495”,
Mendeley Data, v1
http://dx.doi.org/10.17632/8bk6h6bmkr.1
JSON-LD
Irene S. Gabashvili. (2017) Community-led research discovers links between elusive symptoms and clinical tests. BiorXiv. DOI: 10.1101/139014
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