Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada
Bibliographic record
Abstract
AIM: This was a pilot clinical trial to assess biochemical and clinical effects of an oral probiotic dietary supplement in chronic kidney disease (CKD) patients (stages 3 and 4). METHODS: A prospective, randomized, double-blind, crossover, placebo-controlled, 6-month trial of probiotic bacteria was conducted in 16 outpatients in Ontario, Canada. Primary endpoints included effect on hematologic, biochemical, and fecal variables, and on general well-being as assessed by quality of life (QOL). These outcomes were evaluated from biochemical parameters, mainly blood urea nitrogen (BUN), creatinine, uric acid, and C-reactive protein (CRP) as a general inflammatory marker. QOL was assessed on a subjective scale of 1 to 10 as the secondary parameter. TRIAL REGISTRATION: This pilot study forms part of registered trial NCT00760162. RESULTS: A total of 13 patients completed the study. Three patients dropped out: one was the receiver of a transplant. The second dropped out for unknown reasons and the third died of myocardial infarction (unrelated to probiotic bacteria or the protocol). Among the 13 patients who completed the trial, the mean change in BUN concentration during the probiotic treatment period (-2.93 mmol/L) differed significantly (p = 0.002) from the mean change in BUN concentration during the placebo period (4.52 mmol/L). In addition, the mean changes in uric acid concentration were moderate during the KB period (24.70 micromol/L) versus during the placebo period (50.62 micromol/L, p = 0.050), and the changes in serum creatinine concentration were insignificant. Neither gastrointestinal nor infectious complications were noted in any subject with improved QOL. CONCLUSION: Orally administered probiotic bacteria selected to metabolize nitrogenous wastes may be tolerated for as long as 6 months. A major limitation of this trial is its small size that may have precluded detection of changes in other biochemical or hematologic parameters that would be evident in larger cohorts. Extension of the evaluation of this probiotic bacterial mixture will include a dose escalation trial in a similar prospective, placebo-controlled, and double-blind study site.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".