Evidence map›Paper›PMID 30221898›Full record

ArticleRevista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia2018

Fecal microbiota transplantation for recurrent Clostridium difficile infection: Experience, protocol, and results.

E Reigadas, M Olmedo, M Valerio, S Vázquez-Cuesta, L Alcalá, M Marín, P Muñoz, E Bouza

Registry-linked trialAbstract read
In one paragraph

Article in Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05201079 (A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05201079 phase3completednot on this mapstarted 2021, after this paper: background citation

A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin.

TypeinterventionalSponsorMikrobiomik Healthcare Company S.L.Ran2021 to 2023Enrolled93ConditionsRecurrent Clostridium Difficile Infection, Primary Clostridium Difficile InfectionArmsMBK-01, Fidaxomicin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Review
  4. Article
  5. New Procedure to Maintain Fecal Microbiota in a Dry Matrix Ready to Encapsulate.Frontiers in cellular and infection microbiology · 2022
    Article
  6. Article
  7. Fecal Microbiota Transplantation for RecurrentGastroenterology research · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

E ReigadasElena Reigadas Ramírez, Servicio de Microbiología Clínica y Enfermedades Infecciosas, Hospital General Universitario "Gregorio Marañón" C/ Dr. Esquerdo, 46, 28007 Madrid, Spain. helenrei@hotmail.com.
M Olmedo
M Valerio
S Vázquez-Cuesta
L Alcalá
M Marín
P Muñoz
E BouzaEmilio Bouza Santiago, Instituto de Investigación Sanitaria Gregorio Marañón, C/ Dr. Esquerdo, 46,28007 Madrid, Spain. emilio.bouza@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveFecal microbiota transplantation (FMT) is a highly effective therapy for recurrent Clostridium difficile infection (R-CDI). Despite its excellent efficacy, it is still not a routine procedure in most European centers. FMT has not been widely used in Spain to date. We describe our experience with FMT, including a novel approach based on oral fecal capsules.

methodsWe analyzed a prospectively recorded case series of patients with R-CDI treated with FMT at a single center (June 2014-July 2017). Primary outcome was defined as resolution of CDI without recurrence in a two-month period. FMT was administered via colonoscopy, nasojejunal tube, or oral capsules. All stool donors were rigorously screened.

resultsFMT was performed in 13 patients with R-CDI. Median age was 75.0 years and 76.9% were females. Six FMT were performed via nasojejunal tube, 5 via oral capsules, and 2 by colonoscopy. There were no procedure-related adverse events, except for bacteremia in one patient. During follow-up, R- CDI was observed in one patient at one month after FMT. The primary resolution rate was 83.3% and the overall resolution rate was 91.7%. FMT by capsules achieved a 100% resolution rate, colonoscopy 100%, and nasojejunal tube 80.0%.

conclusionsIn our cohort, FMT proved to be safe and effective, even in high risk patients. Oral administration in capsules also proved to be safe, well-tolerated, and highly effective for R-CDI. In our experience, the FMT capsule formulation seems feasible in the routine of a hospital. This administration method will allow FMT to be more widely used.

Indexed as

Clostridioides difficileMicrobiotaAdministration, OralAdultAgedAged, 80 and overBacteremiaCapsulesColonoscopyEnterocolitis, PseudomembranousFecal Microbiota TransplantationFemaleHumansIntubation, GastrointestinalMaleMiddle AgedCapsules

Identifiers

PMID30221898
PMCPMC6194865

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.