Donor Efficacy in Fecal Microbiota Transplantation for Recurrent Clostridium difficile: Evidence From a 1,999-Patient Cohort
Notice bibliographique
Résumé
Background. Recurrent Clostridium difficile infection (CDI) is a public health challenge and fecal microbiota transplantation (FMT) has emerged as an effective therapeutic option. Although FMT is used for treating recurrent CDI, there is no robust evidence evaluating if different donors have an impact on the clinical cure rate. We aim to evaluate if there are differences in FMT efficacy for CDI between donors from a public stool bank. Methods. Donors were selected using a 178-point clinical assessment and 30 laboratory investigations for infectious and microbiome-mediated diseases where only 2.8% of candidate donors qualify. Among selected donors, fecal microbiota preparations (FMPs) were produced according to standard FMP manufacturing practices. Donor-specific units were tracked by a quality assurance (QA) system that linked to de-identified individual patient outcomes. QA data was consecutively collected from 482 healthcare facilities across 50 states and 7 countries between January 16, 2014 and April 12, 2016. Donors were included if their material was used in over 10 reported patients over the study period. The primary outcome was physician reported clinical cure as per standard of care follow-up. Descriptive statistics and chi-square analysis was conducted. Results. Overall, 28 donors (Figure 1) were used in 1,999 patients. Overall, the clinical cure rate from physician-reported data across all 28 donors was 84.4% with a range of 69.2–95.2% (Figure 2). One outlier donor was found to have a statistically significant lower clinical cure rate (70.9%, p = 0.05). However, upon sensitivity analysis, the lower efficacy was driven by one site (overall clinical cure for all donors at site of 50.7%, p < 0.05) and the reduced clinical cure rate was not seen across other hospitals that the donor's material was used. Otherwise, there was no statistically significant differences between donor FMT material and clinical cure for CDI not responsive to standard therapy. Figure 1: Donor characteristics Figure 2: Clinical efficacy reported by donor Conclusion. To our knowledge, this is the largest study assessing clinical efficacy for FMT in CDI by donor and suggests it is unlikely that different donors have an impact on efficacy. Disclosures. M. Osman, OpenBiome: Employee, Salary; Z. Stoltzner, OpenBiome: Employee, Salary; K. O'Brien, OpenBiome: Employee, Salary; K. Ling, OpenBiome: Employee, Salary; E. Koelsch, OpenBiome: Employee, Salary; N. Dubois, OpenBiome: Employee, Salary; M. Smith, OpenBiome: Employee, Salary. Finch Therapeutic: Board Member, Employee and Shareholder, Equity and Salary; Z. Kassam, OpenBiome: Employee, Salary. Finch Therapeutic: Consultant and Shareholder, Equity and Research support
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,010 | 0,015 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».