Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry

Background & Aims Fecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers. Methods Patients undergoing FMT in clinical practices across North America were eligible. Participating investigators enter de-identified data into an online platform, including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes. Results Of the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%). Conclusions This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT

Pointing and naming are not redundant: Children use gesture to modify nouns before they modify nouns in speech.

Nouns form the first building blocks of children’s language, but are not consistently modified by other words until around 2 ½ years of age. Before then, children often combine their nouns with gestures that indicate the object labeled by the noun, for example, pointing at a bottle while saying “bottle.” These gestures are typically assumed to be redundant with speech. Here we present data challenging this assumption, suggesting that these early pointing gestures serve a determiner-like function (i.e., point at bottle + “bottle” = that bottle). Using longitudinal data from 18 children (8 girls), we analyzed all utterances containing nouns and focused on (1) utterances containing an unmodified noun combined with a pointing gesture, and (2) utterances containing a noun modified by a determiner. We found that the age at which children first produced point+noun combinations predicted the onset age for determiner+noun combinations. Moreover, point+noun combinations decreased following the onset of determiner+noun constructions. Importantly, combinations of pointing gestures with other types of speech (e.g., point at bottle + “gimme” = gimme that) did not relate to the onset or offset of determiner+noun constructions. Point+noun combinations thus appear to selectively predict the development of a new construction in speech. When children point to an object and simultaneously label it, they are beginning to develop their understanding of nouns as a modifiable unit of speech

Pointing and Naming Are Not Redundant: Children Use Gesture to Modify Nouns Before They Modify Nouns in Speech

Nouns form the first building blocks of children's language but are not consistently modified by other words until around 2.5 years of age. Before then, children often combine their nouns with gestures that indicate the object labeled by the noun, for example, pointing at a bottle while saying "bottle." These gestures are typically assumed to be redundant with speech. Here we present data challenging this assumption, suggesting that these early pointing gestures serve a determiner-like function (i.e., point at bottle + "bottle" = that bottle). Using longitudinal data from 18 children (8 girls), we analyzed all utterances containing nouns and focused on (a) utterances containing an unmodified noun combined with a pointing gesture and (b) utterances containing a noun modified by a determiner. We found that the age at which children first produced point + noun combinations predicted the onset age for determiner + noun combinations. Moreover, point + noun combinations decreased following the onset of determiner + noun constructions. Importantly, combinations of pointing gestures with other types of speech (e.g., point at bottle + "gimme" = gimme that) did not relate to the onset or offset of determiner + noun constructions. Point + noun combinations thus appear to selectively predict the development of a new construction in speech. When children point to an object and simultaneously label it, they are beginning to develop their understanding of nouns as a modifiable unit of speech

Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry

Background & aimsFecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers.MethodsPatients undergoing FMT in clinical practices across North America were eligible. Participating investigators enter de-identified data into an online platform, including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes.ResultsOf the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%).ConclusionsThis prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT