MP09: Canadian Community Utilization of Stroke Prevention Pilot Study-Emergency Department (C-CUSP ED)

Introduction: Atrial fibrillation (AF) is the most common sustained arrhythmia affecting 1-2% of the population. Oral anticoagulation (OAC) reduces stroke risk by 60-80% in AF patients, but only 50% of indicated patients receive OAC. Many patients present to the ED with AF due to arrhythmia symptoms, however; lack of OAC prescription in the ED has been identified as a significant gap in the care of AF patients. Methods: This was a multi-center, pragmatic, three-phase before-after study, in three Canadian sites. Patients who presented to the ED with electrocardiographically (ECG) documented, nonvalvular AF and were discharged home were included. Phase 1 was a retrospective chart review to determine OAC prescription of AF patients in each ED; Phase 2 was a low-intensity knowledge translation intervention where a simple OAC-prescription tool for ED physicians with subsequent short-term OAC prescription was used, as well as an AF patient education package and a letter to family physicians; phase 3 incorporated Phase 2 interventions, but added immediate follow-up in a community AF clinic. The primary outcome of the study was the rate of new OAC prescriptions at ED discharge in AF patients who were OAC eligible and were not on OAC at presentation. Results: A total of 632 patients were included from June, 2015-November, 2016. ED census ranged from 30000-68000 annual visits. Mean age was 71±15, 67±12, 67±13 years, respectively. 47.5% were women, most responsible ED diagnosis was AF in 75.8%. The mean CHA2DS2-VASc score was 2.6±1.8, with no difference amongst groups. There were 266 patients eligible for OAC and were not on this at presentation. In this group, the prescription of new OAC was 15.8% in Phase 1 as compared to 54% and 47%, in Phases 2 and 3, respectively. After adjustment for center, components of the CHA2DS2-VASc score, prior risk of bleeding and most responsible ED diagnosis, the odds ratio for new OAC prescription was 8.0 (95%CI (3.5,18.3) p<0.001) for Phase 3 vs 1, and 10.0 (95%CI (4.4,22.9) p<0.001), for Phase 2 vs 1). No difference in OAC prescription was seen between Phases 2 and 3. Conclusion: Use of a simple OAC-prescription tool was associated with an increase in new OAC prescription in the ED for eligible patients with AF. Further testing in a rigorous study design to assess the effect of this practice on stroke prevention in the AF patients who present to the ED is indicated.

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Phase 2 dose multi-center, open-label study of ARQ 501, a checkpoint activator, in adult patients with persistent, recurrent or metastatic leiomyosarcoma (LMS)

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.20521 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 20521-20521 ◽

Cited By ~ 15

Author(s):

L. P. Hartner ◽

L. Rosen ◽

M. Hensley ◽

D. Mendelson ◽

A. P. Staddon ◽

...

Keyword(s):

Clinical Investigation ◽

Phase 1 ◽

Phase 2 ◽

Open Label ◽

Open Label Study ◽

Apoptotic Protein ◽

Three Phase ◽

Phase 2 Study ◽

Lost To Follow Up

20521 Background: ARQ 501 selectively induces apoptosis in cancer cells by inducing a rapid and sustained increase of the pro- apoptotic protein E2F-1. ARQ 501 has been studied in three phase 1 studies, demonstrating acceptable toxicity and encouraging signs of efficacy. A 54 y/o female with metastatic LMS who failed 7 previous therapies achieved a prolonged PR on ARQ 501 monotherapy. This was consistent with preclinical data, where induction of E2F-1 and corresponding efficacy in human leiomyosarcoma xenografts was observed. Methods: A phase 2 study in adult LMS patients (>3 prior systemic therapies) was initiated to assess ORR, TTP and further characterize the safety of ARQ 501. ORR included CR, PR and SD=4 mo. Four week cycles (ARQ 501 450mg/m2) were repeated until progression, unacceptable toxicity, or another discontinuation criterion. Results: 49 patients were enrolled and 45 received ARQ 501. Data is available for 43 patients (4M/39F, median age, 54). Of the 43, 10 did not reach a protocol defined tumor assessment (4 deaths, 5 PD and 1 lost to follow-up prior to week 8), 19 have been assessed for response per RECIST at eight weeks (7 SD of 8–28+ weeks, 1 PR, 11 PD) and 14 active patients yet to reach first tumor assessment. The most common AEs were: anemia (68%, 21%=G3), hyperbilirubinemia (35%, 6%=G3), fatigue (35%, 0%=G3), nausea (30%, 0%=G3), constipation (24%), hemolysis (21%, 6%=G3), dyspnea (21%), and vomiting (21%). One treatment related death was reported in a 47 y/o Asian male with severe hemolysis following a single infusion of ARQ 501 at 450 mg/m2. The pt was hospitalized, but severe hemolysis led to acute renal failure and the patient expired after 4 days. Conclusions: ARQ 501 was administered to 45 patients with advanced, recurrent or persistent leiomyosarcoma. Several patients have achieved some clinical benefit (1 PR, 3 prolonged SD), further analysis of efficacy data is warranted prior to additional clinical investigation. No significant financial relationships to disclose.

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Safety of TG-C: 12 years of follow-up safety data from phase 1, phase 2, ongoing phase 3, and long term safety trials

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2021.02.338 ◽

2021 ◽

Vol 29 ◽

pp. S253-S254

Author(s):

D. Hunter ◽

A. Mobasheri ◽

S. Mareya ◽

M. Wang ◽

H. Choi ◽

...

Keyword(s):

Phase 1 ◽

Safety Data ◽

Phase 2 ◽

Phase 3 ◽

Ongoing Phase

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Hospitalization due to Adverse Drug Reactions and Drug Interactions before and after HAART

Canadian Journal of Infectious Diseases ◽

10.1155/2000/123046 ◽

2000 ◽

Vol 11 (4) ◽

pp. 193-201 ◽

Cited By ~ 3

Author(s):

Michelle M Foisy ◽

Kevin Gough ◽

Corinna M Quan ◽

Kevin Harris ◽

Dominique Ibanez ◽

...

Keyword(s):

Adverse Drug Reactions ◽

Highly Active Antiretroviral Therapy ◽

Phase 1 ◽

Tertiary Care ◽

Retrospective Chart Review ◽

Partial Recovery ◽

Phase 2 ◽

Drug Reactions ◽

Tertiary Care Centre ◽

The Mean

OBJECTIVE: To characterize and compare the rates of adverse drug reactions (ADRs) and interactions on admission in two, one-year periods: pre-highly active antiretroviral therapy (HAART) (phase 1) and post-HAART (phase 2).DESIGN: Retrospective chart review.SETTING:University-affiliated tertiary care centre.POPULATION STUDIED: HIV-positive patients admitted to hospital.MAIN RESULTS: In phase 1, 436 of 517 admissions, and, in phase 2, 323 of 350 admissions were analyzed. Over 92% of patients were male, with a mean age of 38 years. Significant differences (P<0.05) in the mean length of stay (12.08 versus 10.02 days), the CD4 counts (99.25 versus 129.45) and the number of concurrent diseases (4.20 versus 3.63) were found between phase 1 and 2, respectively. The mean number of medications taken (5.52 versus 5.94) and the rates of hospitalization with ADRs (20.4% versus 21.4%) or interactions (2.5% versus 2.16%) were similar between the two phases. Antiretrovirals were more common in ADR admissions post-HAART (21.3% versus 36.2%), while antiparasitics, psychotherapeutics and antineoplastics were more common pre-HAART. Other classes of drugs involved in both phases were sulphonamides, narcotics, ganciclovir, foscarnet, antimycobacterials and antifungals. ADR causality was possible or probable in more than 80% of cases. Over 60% of ADRs were grades 3 to 4, and about 85% were either the main or contributing reason for admission. About 65% of patients had at least partial recovery at the time of discharge. In phases 1 and 2, 8.9% and 2.9% of admissions,respectively, with ADRs were fatal.CONCLUSIONS: Although hospitalizations with ADRs and interactions were similar in both phases, HAART therapy has had a significant impact on the incidence and nature of ADRs at St Michael?s Hospital, Wellesley Central Site, Toronto, Ontario.

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P095: Preparing emergency patients and providers study: Clinician and patient satisfaction with communication tool

CJEM ◽

10.1017/cem.2019.286 ◽

2019 ◽

Vol 21 (S1) ◽

pp. S98

Author(s):

J. Nunn ◽

D. Chiasson ◽

C. Cassidy ◽

S. MacPhee ◽

B. Rose-Davis ◽

...

Keyword(s):

Nova Scotia ◽

Response Rate ◽

Phase 1 ◽

Descriptive Statistics ◽

Phase 2 ◽

Phase 3 ◽

Item Questionnaire ◽

Ed Visits ◽

The Impact

Introduction: Effective communication to develop a shared understanding of patient/caregiver (P/C) expectations is critical during emergency department (ED) encounters. However, there is limited research examining the use of communication tools of P/C expectations to improve communication in the ED. The objective of this study was to examine satisfaction with a patient expectations questionnaire, known as the PrEPP tool, and its impact on communication and management of patients in the ED. Methods: The PrEPP tool collected P/C expectations over 3 phases of the study. In phase1, the PrEPP tool was distributed to all P/Cs (CTAS score of 2 to 5) in four EDs in Nova Scotia. In phase 2 the PrEPP tool was refined to a 5-item questionnaire. In phase 3 the PrEPP tool was re-implemented over a six-month period. Follow-up surveys were distributed to P/Cs via email (phase 1, 3) and HCPs on iPads in the ED (phase 3) to determine the impact of the tool on communication and management of patients. Entries were compiled on a REDCap database and descriptive statistics were used to analyze responses related to satisfaction.The PrEPP tool collected P/C expectations over 3 phases of the study. In phase1, the PrEPP tool was distributed to all P/Cs (CTAS score of 2 to 5) in four EDs in Nova Scotia. In phase 2 the PrEPP tool was refined to a 5-item questionnaire. In phase 3 the PrEPP tool was re-implemented over a six-month period. Follow-up surveys were distributed to P/Cs via email (phase 1, 3) and HCPs on iPads in the ED (phase 3) to determine the impact of the tool on communication and management of patients. Entries were compiled on a REDCap database and descriptive statistics were used to analyze responses related to satisfaction. Results: In Phase 1, 11418 PrEPP tools and 147 surveys (29% response rate) were collected from January-June 2016. The majority of P/Cs found the PrEPP questionnaire easy to complete (95.9%) and felt HCPs met their expectations (87.1%). In Phase 3, 951 P/C (31.1% response rate) and 128 HCP surveys were collected. Of P/C respondents 45.9% felt PrEPP helped to communicate expectations, while 49.7% said that they would like to use it on future ED visits. The majority of P/C respondents (75.4%) indicated their expectations were met during their visit to the ED. Of those whose expectations were not met, 69% felt their expectations were not discussed. The majority of HCP respondents (90.4%) indicated they used the PrEPP tool at least sometimes. Also, 78.4% said it influenced patient communication and 42% indicated the tool influenced management of patients at least sometimes. Conclusion: Obtaining expectations early in the patient encounter may provide opportunities for improved communication in the ED. P/Cs found the PrEPP tool easy to use to communicate their expectations and HCPs felt it influenced communication and management of patients in the ED. Further qualitative thematic analysis is needed to explore how the PrEPP tool impacted ED visits.

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OS09.6 Long-term follow-up data from 126 patients with recurrent high grade glioma from three Phase 1 trials of Toca 511 and Toca FC: Update and justification for a Phase 2/3 trial

Neuro-Oncology ◽

10.1093/neuonc/nox036.065 ◽

2017 ◽

Vol 19 (suppl_3) ◽

pp. iii19-iii19

Author(s):

M. Aghi ◽

M. A. Vogelbaum ◽

S. N. Kalkanis ◽

D. Bota ◽

D. Piccioni ◽

...

Keyword(s):

Phase 1 ◽

High Grade Glioma ◽

High Grade ◽

Phase 2 ◽

Phase 1 Trials ◽

Three Phase ◽

Long Term Follow Up

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PENERAPAN MODEL QUANTUM LEARNING UNTUK MENINGKATKAN HASIL BELAJAR AUTOCAD SISWA KELAS X TEKNIK PEMESINAN SMK NEGERI 1 STABAT

Jurnal Teknologi Pendidikan (JTP) ◽

10.24114/jtp.v5i1.509 ◽

2013 ◽

Vol 5 (1) ◽

Author(s):

Abdul Hasan Saragih

Keyword(s):

Positive Response ◽

Phase 1 ◽

First Grade ◽

Learning Model ◽

Second Phase ◽

Phase 2 ◽

Phase 3 ◽

The Third ◽

Third Phase ◽

Quantum Learning

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.

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Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

Advances in Pulmonary Hypertension ◽

10.21693/1933-088x-9.4.214 ◽

2010 ◽

Vol 9 (4) ◽

pp. 214-219

Author(s):

Robyn J. Barst

Keyword(s):

Clinical Trials ◽

Pulmonary Arterial Hypertension ◽

Drug Development ◽

Phase 1 ◽

Preclinical Studies ◽

Phase 2 ◽

Phase 3 ◽

Preclinical Testing ◽

New Drug ◽

Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

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Quantitative Checklist for Autism in Toddlers (Q-CHAT). A population screening study with follow-up: the case for multiple time-point screening for autism

BMJ Paediatrics Open ◽

10.1136/bmjpo-2020-000700 ◽

2021 ◽

Vol 5 (1) ◽

pp. e000700

Author(s):

Carrie Allison ◽

Fiona E Matthews ◽

Liliana Ruta ◽

Greg Pasco ◽

Renee Soufer ◽

...

Keyword(s):

Phase 1 ◽

Autism Spectrum ◽

Population Screening ◽

Diagnostic Assessment ◽

Test Accuracy ◽

Multiple Time ◽

Phase 2 ◽

Time Points ◽

Screening Study

ObjectiveThis is a prospective population screening study for autism in toddlers aged 18–30 months old using the Quantitative Checklist for Autism in Toddlers (Q-CHAT), with follow-up at age 4.DesignObservational study.SettingLuton, Bedfordshire and Cambridgeshire in the UK.Participants13 070 toddlers registered on the Child Health Surveillance Database between March 2008 and April 2009, with follow-up at age 4; 3770 (29%) were screened for autism at 18–30 months using the Q-CHAT and the Childhood Autism Spectrum Test (CAST) at follow-up at age 4.InterventionsA stratified sample across the Q-CHAT score distribution was invited for diagnostic assessment (phase 1). The 4-year follow-up included the CAST and the Checklist for Referral (CFR). All with CAST ≥15, phase 1 diagnostic assessment or with developmental concerns on the CFR were invited for diagnostic assessment (phase 2). Standardised diagnostic assessment at both time-points was conducted to establish the test accuracy of the Q-CHAT.Main outcome measuresConsensus diagnostic outcome at phase 1 and phase 2.ResultsAt phase 1, 3770 Q-CHATs were returned (29% response) and 121 undertook diagnostic assessment, of whom 11 met the criteria for autism. All 11 screened positive on the Q-CHAT. The positive predictive value (PPV) at a cut-point of 39 was 17% (95% CI 8% to 31%). At phase 2, 2005 of 3472 CASTs and CFRs were returned (58% response). 159 underwent diagnostic assessment, including 82 assessed in phase 1. All children meeting the criteria for autism identified via the Q-CHAT at phase 1 also met the criteria at phase 2. The PPV was 28% (95% CI 15% to 46%) after phase 1 and phase 2.ConclusionsThe Q-CHAT can be used at 18–30 months to identify autism and enable accelerated referral for diagnostic assessment. The low PPV suggests that for every true positive there would, however, be ~4–5 false positives. At follow-up, new cases were identified, illustrating the need for continued surveillance and rescreening at multiple time-points using developmentally sensitive instruments. Not all children who later receive a diagnosis of autism are detectable during the toddler period.

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PSVI-3 Dietary supplementation with coated omega-3 fatty acids has positive effects on growth performance and nutrients digestibility in weaned pigs

Journal of Animal Science ◽

10.1093/jas/skaa054.343 ◽

2020 ◽

Vol 98 (Supplement_3) ◽

pp. 196-197

Author(s):

Woo Jung Seok ◽

Je min Ahn ◽

Jing Hu ◽

Dexin Dang ◽

Yanjiao Li ◽

...

Keyword(s):

Fatty Acids ◽

Growth Performance ◽

Phase 1 ◽

Dietary Supplementation ◽

Basal Diet ◽

Phase 2 ◽

Omega 3 ◽

Phase 3 ◽

Linear Effect ◽

Weaning Pigs

Abstract The objective of this study was to evaluate the effects of dietary supplementation of coated omega-3 fatty acid (n-3 CFA) by corn cob power silica on performance of weaning pigs. A total of 200 weaned pigs [(Landrace x Yorkshire) x Duroc, average initial body weight at 6.97 ± 1.22 kg] were randomly assigned to four experimental treatments in a 6-week experiment in 3 phases as follows: CON, basal diet; 2) 0.3CFA, CON + phase 1(0.3% n-3CFA), phase 2(0.2% n-3CFA), phase 3(0.1% n-3CFA); 3) 0.6CFA, CON + phase 1(0.6% n-3CFA), phase 2(0.4% n-3CFA), phase 3(0.2% n-3CFA); 4) 0.9CFA, CON + phase 1(0.9% n-3CFA), phase 2(0.6% n-3CFA), phase 3 (0.3% n-3CFA). Each treatment had 10 replicates with 5 pigs (three gilts and two barrows) per replicate. The data were analyzed using the GLM procedure of SAS as a randomized complete block design. Pen served as the experimental unit. Linear, quadratic and cubic polynomial contrasts were used to examine effect of dietary treatment with coated n-3FA in the basal diet. Variability in the data was expressed as the standard error of means and P< 0.05 was considered to statistically significant. Increasing the level of n-3CFA in the diet linearly increased ADG and G/F of pigs (Table 1). Increasing the level of n-3CFA showed a linear increment in the digestibility of DM (83.59, 84.38, 85.13, 85.89 %) whereas nitrogen digestibility (81.79, 82.38, 82.96, 83.64 %) showed a trend (linear effect, p=0.0594) at the end of experiment. The fecal lactobacillus count was increased (7.22, 7.27, 7.33, 7.35 log10cfu/g) with the increase in the supplemental level of n-3CFA (linear effect; p< 0.05). However, there were no differences in the concentration of serum haptoglobin, or fecal E. coli, Clostridium and Salmonella counts despite the increase in n-3CFA levels in the diet. Supplementation of the diet with coated n-3 fatty acids positively affected growth performance and digestibility of dry matter and nitrogen, and enhanced the count of lactobacillus in weaning pigs.

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Dietary Inclusion of Blood Plasma with Yeast (Saccharomyces cerevisiae) Supplementation Enhanced the Growth Performance, Nutrient Digestibility, Lactobacillus Count, and Reduced Gas Emissions in Weaning Pigs

Animals ◽

10.3390/ani11030759 ◽

2021 ◽

Vol 11 (3) ◽

pp. 759

Author(s):

Vetriselvi Sampath ◽

Dong Heon Baek ◽

Sureshkumar Shanmugam ◽

In Ho Kim

Keyword(s):

Saccharomyces Cerevisiae ◽

Phase 1 ◽

Average Daily Gain ◽

Nutrient Digestibility ◽

Phase 2 ◽

Phase 3 ◽

Yeast Saccharomyces Cerevisiae ◽

Yeast Phase ◽

Weaning Pigs ◽

Daily Gain

This experiment was performed to examine the hypothesis that blood plasma (BP) with yeast (Saccharomyces cerevisiae) supplement in the diet of weaning pigs could provoke the growth performance, nutrient digestibility, fecal microbial, and reduce harmful gas excretion. A total of one hundred and eighty healthy piglets were taken and assigned (complete random blocks) to three dietary treatments as: Phase 1: Treatment (TRT) 1-6% BP; TRT 2-3% BP + 3% yeast; TRT 3-6% yeast. Phase 2: TRT 1-3%; BP., TRT 2-1.5% BP + 1.5% yeast; TRT 3- 3% yeast. Phase 3: TRT 1- Control (CON) (Basal diet); TRT 2- CON; TRT 3- CON for six- weeks. Each treatment had twelve replicates and five (three gilts and two barrows) pigs per pen. Dietary inclusion of BP with yeast supplementation significantly increased the body weight of piglets during phase 2 (p = 0.003) and phase 3 (p = 0.032). In addition, TRT2 group piglets had a significant improvement in average daily gain at the end of each phase and overall (p = 0.047, 0.025, 0.018 and 0.012, respectively). At phase 3, TRT2 group piglets showed a significant improvement on nutrient digestibility of dry matter (p = 0.012) and nitrogen (p = 0.040). The fecal microbiota of TRT2 group piglets showed a tendency to increase the number of Lactobacillus counts at phase 1 (p = 0.07) and phase 2 (p = 0.06) as well as, a significant improvement at phase 3 (p = 0.021). In addition, TRT2 group piglets had trend to decrease NH3 (p = 0.074) and H2S (p = 0.069) during phase 2, and significantly reduced NH3 (p = 0.038) and H2S (p = 0.046) at phase 3. However, the fecal score of piglets remains unaffected during the entire trial. At the end of phase 1 piglets’ IgG (p = 0.008) was significantly increased with the inclusion of BP with yeast supplementation. Based on the positive effects on body weight, average daily gain, nutrient digestibility, Lactobacillus count, and reduced gas emission, we suggest that dietary supplement with BP and yeast in the diet of weaned piglet could serve as an excellent alternative to antibiotics growth promoters.

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