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1.
medRxiv ; 2023 Feb 01.
Article in English | MEDLINE | ID: mdl-36778473

ABSTRACT

Background: Fecal Microbiota Transplant (FMT) has proven effective in treating recurrent Clostridioides difficile infection (rCDI) and has shown some success in treating inflammatory bowel diseases (IBD). There is emerging evidence that host engraftment of donor taxa is a tenet of successful FMT. However, there is little known regarding predictors of engraftment. We undertook a double-blind, randomized, placebo-controlled pilot study to characterize the response to FMT in children and young adults with mild to moderate active Crohn's disease (CD) and ulcerative colitis (UC). Results: Subjects with CD or UC were randomized to receive antibiotics and weekly FMT or placebo in addition to baseline medications. The treatment arm received seven days of antibiotics followed by FMT enema and then capsules weekly for seven weeks. We enrolled four subjects with CD and 11 with UC, ages 14-29 years. Due to weekly stool sampling, we were able to create a time series of alpha diversity, beta diversity and engraftment as they related to clinical response. Subjects exhibited a wide range of microbial diversity and donor engraftment as FMT progressed. Specifically, engraftment ranged from 26% to 90% at week 2 and 3% to 92% at two months. Consistent with the current literature, increases over time of both alpha diversity (p< 0.05) and donor engraftment (p< 0.05) correlated with improved clinical response. Additionally, our weekly time series enabled an investigation into the clinical and microbial correlates of engraftment at various time points. We discovered that the post-antibiotic but pre-FMT time point, often overlooked in FMT trials, was rich in microbial correlates of eventual engraftment. Greater residual alpha diversity after antibiotic treatment was positively correlated with engraftment and subsequent clinical response. Interestingly, a transient rise in the relative abundance of Lactobacillus was also positively correlated with engraftment, a finding that we recapitulated with our analysis of another FMT trial with publicly available weekly sequencing data. Conclusions: We found that higher residual alpha diversity and Lactobacillus blooms after antibiotic treatment correlated with improved engraftment and clinical response to FMT. Future studies should closely examine the host microbial communities pre-FMT and the impact of antibiotic preconditioning on engraftment and response.

2.
J Nurs Scholarsh ; 54(1): 104-116, 2022 01.
Article in English | MEDLINE | ID: mdl-34811882

ABSTRACT

PURPOSE: To review the extant literature relevant to perceptions by direct care nurses toward clinical research endeavors. DESIGN: An integrative review guided by the socioecological model was conducted. METHODS: Five databases were searched to identify relevant peer-reviewed articles; there was no limitation on publication date. FINDINGS: The final sample (N = 9) was systematically appraised. Numerous barriers to direct care nurses' ability to perform study activities on clinical research trials were encountered at all levels: (1) personal-comprehension, education, and training; (2) interpersonal-communication issues within or from the study team, failure to advocate for the patient; (3) organizational-lack of leadership support, knowledge, and time; and (4) community-insufficient guidance and oversight by research-governing bodies. CONCLUSIONS: Direct care nurses report numerous barriers to completing protocol-administered activities for their patients participating in clinical research. A dearth of robust research exists in describing the reasons for, or persistence of, barriers faced by direct care nurses to assisting with research, and there have been little to no interventions to address them. CLINICAL RELEVANCE: As translational research evolves and becomes more complex, there is the need to ensure both the care of clinical research participants and the integrity of the research. Direct care nurses are critical to this endeavor, and potential barriers they face may have significant ramifications for the research enterprise. Recognition of these barriers and eventual interventions designed to address them are needed.


Subject(s)
Leadership , Nurses , Humans
3.
N Engl J Med ; 381(17): 1644-1652, 2019 10 24.
Article in English | MEDLINE | ID: mdl-31597037

ABSTRACT

Genome sequencing is often pivotal in the diagnosis of rare diseases, but many of these conditions lack specific treatments. We describe how molecular diagnosis of a rare, fatal neurodegenerative condition led to the rational design, testing, and manufacture of milasen, a splice-modulating antisense oligonucleotide drug tailored to a particular patient. Proof-of-concept experiments in cell lines from the patient served as the basis for launching an "N-of-1" study of milasen within 1 year after first contact with the patient. There were no serious adverse events, and treatment was associated with objective reduction in seizures (determined by electroencephalography and parental reporting). This study offers a possible template for the rapid development of patient-customized treatments. (Funded by Mila's Miracle Foundation and others.).


Subject(s)
Membrane Transport Proteins/genetics , Mutagenesis, Insertional , Neuronal Ceroid-Lipofuscinoses/drug therapy , Neuronal Ceroid-Lipofuscinoses/genetics , Oligonucleotides, Antisense/therapeutic use , Precision Medicine , Rare Diseases/drug therapy , Biopsy , Child , Child Development , Drug Discovery , Drugs, Investigational/therapeutic use , Electroencephalography , Female , Humans , Neuropsychological Tests , RNA, Messenger , Seizures/diagnosis , Seizures/drug therapy , Skin/pathology , Whole Genome Sequencing
4.
J Perianesth Nurs ; 32(4): 352-355, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28739067

ABSTRACT

This article describes the distinctive function of the pediatric clinical research nurse (CRN) in the anesthesia setting. The pediatric CRN in anesthesia acts as a liaison between families and the research team and is the major nexus between the principal investigator or anesthesiologist on a study, and the collaborating surgeons from many different departments. This is unique because the CRNs collaborate with physicians in specialties that can include plastics, urology, neurosurgery, orthopaedics, otolaryngology, cardiology, critical care, and many other departments. The profession requires a breath of knowledge ranging from clinical understanding of diseases, surgical procedures, and recovery to cognitive and developmental stages, to expertise in the research protocol process. Our objective was to describe these specialized activities of the pediatric anesthesia CRN, with focus on care coordination, communication, and continuity of care. Defining this role will enhance the quality of clinical research conducted by the CRN in anesthesia and may influence the development of novel medical treatments.


Subject(s)
Anesthesia , Interprofessional Relations , Nurse's Role , Nursing Research , Pediatric Nursing , Professional-Family Relations , Child , Humans , Patient Care Team
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