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Record W4403119188 · doi:10.1101/2024.10.02.24314795

Double-Blind Randomized Placebo Controlled Trial of a <i>Lactobacillus</i> Probiotic Blend in Chronic Obstructive Pulmonary Disease

2024· preprint· en· W4403119188 on OpenAlexaff
Teodora Nicola, Nancy M. Wenger, Michael Evans, Youfeng Yang, Dongquan Chen, William J. Van Der Pol, A Walia, Elliot J. Lefkowitz, Jun Wang, Ashley LeMoire, Lois Lin, Casey D. Morrow, Namasivayam Ambalavanan, Amit Gaggar, Charitharth Vivek Lal

Bibliographic record

VenuemedRxiv · 2024
Typepreprint
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicGut microbiota and health
Canadian institutionsNutrasource
FundersNational Center for Advancing Translational SciencesNational Institutes of Health
KeywordsProbioticPulmonary diseasePlaceboMedicineRandomized controlled trialDouble blindInternal medicineDiseasePlacebo-controlled studyGastroenterologyBacteriaBiologyPathologyAlternative medicine

Abstract

fetched live from OpenAlex

Abstract Rationale The gut-lung axis describes the crosstalk between the gut and lung wherein microbiota in the gut modulate systemic anti-inflammatory and immune responses in the lungs. Objectives: We hypothesized that a blend of probiotic bacteria ( Lactobacilli ) combined with herbal extracts (resB®) could improve quality of life in COPD patients. Methods We conducted a randomized, double-blinded, placebo-controlled study ( NCT05523180 ) evaluating the safety and impact of resB® on quality of life in volunteers with COPD. Participants took two capsules of resB® or placebo orally daily for 12 weeks. The primary endpoint was quality of life changes by Saint George’s Respiratory Questionnaire (SGRQ). In addition to safety, exploratory endpoints included changes in serum and sputum biomarkers as well as sputum and stool microbiome. Measurements and Main Results resB® was well tolerated by all participants, with no related adverse events reported. Participants who received resB® had improvement in their SGRQ symptom scores from baseline to final visit (P<0.05), while the change in SGRQ symptom scores in those receiving placebo was not significant. Serum and sputum concentrations of matrix metalloproteinase 9, serum c-reactive protein, and serum interleukin 6 decreased (P<0.05) between baseline and final visit in the resB® group, corresponding with an increase in stool Lactobacilli abundance. Relative abundance of Veillonella also increased in stool and sputum in the resB® group. Conclusions Participants with COPD who received resB® improved in respiratory symptoms over a 12-week course. Serum and sputum biomarkers suggest administration of the probiotic and herbal blend reduces inflammation and may thereby attenuate symptoms.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.010
Threshold uncertainty score0.035

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.002
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0060.002
Bibliometrics0.0010.001
Science and technology studies0.0010.002
Scholarly communication0.0010.001
Open science0.0010.001
Research integrity0.0030.003
Insufficient payload (model declined to judge)0.0100.002

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.

Opus teacher head0.018
GPT teacher head0.285
Teacher spread0.268 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

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".

Quick stats

Citations1
Published2024
Admission routes1
Has abstractyes

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