A51 EFFECT OF LYOPHILIZED STERILE FECAL FILTRATE VS LYOPHILIZED DONOR STOOL ON RECURRENT CLOSTRIDIUM DIFFICILE INFECTION (RCDI): PRELIMINARY RESULTS FROM A RANDOMIZED, DOUBLE-BLIND PILOT STUDY
Notice bibliographique
Résumé
Fecal microbial transplantation (FMT) has been shown to be a highly effective therapy for rCDI. Success rate is > 90%. A recent study using sterile fecal filtrate successfully prevented CDI recurrence in 5 patients, suggesting live microbes may not be required for efficacy. To determine whether live microbes are necesary for the clinical efficacy of FMT by comparing treatment outomces in rCDI patients receiving either lyophilized sterile fecal filtrate (LSFF) or lyophilized FMT (LFMT). Primary outcome: proportion of patients in each group with no CDI recurrence at week 8. Secondary outcomes: mortality rate and infections directly attributable to CDI or treatment at week 8. In this single center pilot study, eligible participants with rCDI were randomized to LSFF or LFMT at 1:1. Inclusion criteria: age >18 years; diagnosis of at least 3 episodes of RCDI, each episode defined by presence of diarrhea (≥3 unformed stools/24 h), positive for C. difficile toxin, episodes occurring within 2 months of each other after finishing anti-CDI therapy, and recurring diarrhea after symptom resolution following at least 10 d of anti-CDI therapy; CDI infection under symptomatic control with <3 loose/unformed stools/24 h for at least 2 consecutive days before treatment; and d) ability to provide informed consent. Exclusion criteria: fulminant CDI; chronic diarrheal illness; taking or planning to take investigational drug within 3 months of enrolment; dysphagia; ileus or bowel obstruction, pregnancy; active infection requiring antibiotic therapy; or life expectancy <6 months. Each patient received a single dose of 15 capsules of LFMT or LSFF according to group assigned, under direct observation in clinic. All capsules appeared identical. All patients were seen in the clinic at screening, at week 0 for treatment, and 1, 4, 8 and 24 weeks after treatment. Recurrence of diarrhea ( ≥3 unformed bowel movements/24 h) was evaluated at each follow-up and tested for C difficile. In the event that the first assigned treatment failed to prevent CDI recurrence, open-label FMT was offered. Between Feb 15 and Aug 1, 2019, 4 participants were randomized to the LSFF group and 5 to the LFMT group (table 1). Primary outcome was achieved by 75% (3/4) of the LSFF group and 80% (4/5) of the LFMT group. Both failure cases received a single dose of open-label LFMT and achieved cure. No mortality or FMT-related infections were observed. Our preliminary findings suggest live microbes may not be necessary for the clinical efficacy of FMT in treating rCDI. Further characterization of sterile filtrate and mechanistic studies will lay the foundation for development of refined microbiome-derived therapy for rCDI. University of Alberta Hospital Foundation
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 tête enseignante, 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 ».