bluuebunny/crossref_metadata_2025_split huggingface dataset:
496 Baseline and Longitudinal Microbial Changes Predict Response to Rifaximin and/or Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols in Irritable Bowel Syndrome
Authors: Lee Allen , Rao Krishna , Haller Emily , Van Dam Lauren , Baker Jason , Watts Lydia , Eswaran Shanti , Chey William D. , Owyang Chung , Young Vincent , Hasler William 
Published: October 2019

INTRODUCTION:
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a chronic, disabling condition. Treatments for IBS-D, including rifaximin, a nonabsorbable antibiotic, and a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), improve symptoms in ≤50% of patients. We hypothesized that changes in the gut microbiota predict response to treatment for IBS-D.

METHODS:
We randomized 17 patients meeting Rome IV criteria for IBS-D to receive either rifaximin 550 mg three times daily x 14 days or a low FODMAP diet x 4 wks. The primary outcome was proportion of responders to intervention defined by ≥30% improvement in mean daily abdominal pain or bloating scores. The secondary outcome was ≥50-point decrease in IBS-Severity Symptom Scoring (IBS-SSS) compared with baseline. Fecal samples were collected at baseline and 2, 4 and 5 wks. The microbial community in these specimens was characterized by 16S rRNA encoding-gene sequence analysis.

RESULTS:
There were 6 subjects (60.0%) in the rifaximin group and 4 subjects (57.1%) in the low FODMAP group that met the primary endpoint (P > .99) (Table 1). Patients in the rifaximin group had significant improvements in abdominal pain (P = .01), bloating (P = .02), and IBS-SSS (P = .009) compared with baseline. Patients in the low FODMAP group showed improvement in IBS-SSS only (P = .06) at the end of treatment. Responders to treatment had unique inter- and intra-individual temporal characteristics compared with non-responders. Responders to rifaximin and low FODMAP diet showed a distinct microbial community structure at baseline compared with non-responders (P = .001 for both, Figure 1A). Responders to rifaximin (P = .08) and low FODMAP diet (P = .01) also exhibited lower degrees of microbial community change during therapy compared with non-responders (Figure 1B). Responders to rifaximin (Figure 2A) and low FODMAP diet (Figure 2B) showed changes in several taxa at baseline and longitudinally compared with non-responders.

CONCLUSION:
Responders to therapy with rifaximin and low FODMAP diet show a distinct fecal microbial community structure at baseline. Many microbiome features at baseline predict response to treatment. Longitudinal analyses show responders have a more resilient community structure to either rifaximin or dietary modification compared with non-responders. The functional significance of these microbial changes in responders vs. non-responders is unclear, but may be the focus of future studies.
505 24-Month Post-Marketing Safety Surveillance Data of Caraway Oil and L-menthol With Site Specific Targeting (COLM-SST): A Novel Formulation for FD
Authors: Lacy Brian E. , Epstein Michael S. , Shah Syed , Corsino Patrick 
Published: October 2019

INTRODUCTION:
Functional Dyspepsia (FD) is a common functional GI disorder in the upper abdomen (above the navel). The estimated prevalence is 15-30% worldwide. There are currently no FDA-approved medications for the treatment of FD. Proton pump inhibitors (PPIs) are commonly prescribed off-label. However, long-term use of these drugs has been associated with serious health concerns. Prokinetic agents are also often used off-label. However, many are associated with significant side effects (e.g. metoclopramide). A safe, effective, and readily available treatment option for FD is greatly needed. This study describes an important 24-month post-marketing point on an option for FD that has already demonstrated good efficacy and low side effects in RCTs. These RCTs have demonstrated that the combination of caraway oil and peppermint oil improves FD symptoms. Caraway oil plus L-menthol (the major component of peppermint oil) with site-specific targeting (COLM-SST) is a novel delivery system of triple-coated, solid-state microspheres designed to target the duodenum, the main center of disturbance in FD. This study was conducted to report on the overall safety profile of COLM-SST and to determine if any unexpected pattern of side effects emerged.

METHODS:
A call-in number for reporting adverse events (AEs) was provided on all boxes containing COLM-SST. An independent call center with pharmacovigilance-trained health care personnel, in accordance with the FDA and global regulatory guidelines on properly reporting AEs, was retained to receive and record customer AEs. The AEs for this study were collected and processed from July 8, 2016 to July 8, 2018.

RESULTS:
An estimated 558,345 individual patients used COLM-SST during the surveillance. An analysis of the data showed that there were no serious AEs reported. Additionally, the self-reporting rate of non-serious AEs was low, with only 148 events received (from 127 patients), a 0.023% event rate for COLM-SST. The top reported, non-serious AEs were abdominal pain/discomfort/distension (18; 0.0032%), which were consistent with the pattern of commonly reported symptoms of FD, and headache (7; 0.0013%).

CONCLUSION:
24 months of monitoring in-market, real-world use of caraway oil and L-menthol with site-specific targeting, for the treatment of FD demonstrates an extremely low rate of self-reported AEs. These data, combined with earlier RCT data, indicates that COLM-SST is a safe and effective therapy for FD, and is a viable alternative to PPIs and prokinetics.
506 Impact of Colonoscopy Timing on Rifaximin in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Authors: Lacy Brian E. , Lembo Anthony , Pimental Mark , Heimanson Zeev , Cash Brooks D. 
Published: October 2019

INTRODUCTION:
Bowel preps for colonoscopy can cause transient changes in gut microbiota. Rifaximin is indicated as IBS-D treatment in adults. This post hoc analysis evaluated effect of time since colonoscopy on rifaximin response for IBS-D.

METHODS:
Two phase 3 studies (TARGET 1/2) comprised adults who had documented history of colonoscopy <2 y prior to enrollment for IBS evaluation; otherwise they had 1 within 30 d of signed consent. Patients (pts) were randomized to rifaximin 550 mg TID or placebo for 2 wks. Responders, grouped by time from colonoscopy to treatment start (≤60 d or >60 d), were analyzed using LOCF. Composite responders (FDA endpoint) were pts meeting weekly response criteria for abdominal pain (≥30% decrease from baseline in mean weekly pain score [range, 0-6]) and stool consistency (≥50% decrease from baseline in d/wk with Bristol Stool Scale type 6/7 stool) during ≥2 of first 4 wks posttreatment; responders for individual components also were determined.

RESULTS:
Differences in responder rates between rifaximin and placebo were observed in colonoscopy-timing subgroups (≤60 d or >60 d), with largest differences seen in >60 d group (Figure 1). Among pts who had colonoscopy >60 d prior to starting treatment in TARGET 1, a greater percentage treated with rifaximin (n=109) vs placebo (n=106) were composite (47.7% vs 34.0%; P = 0.04), abdominal pain (53.2% vs 40.6%; P = 0.06), or stool consistency (81.7% vs 63.2%; P = 0.002) responders. For colonoscopy ≤60 d prior to starting treatment, a greater percentage of pts treated with rifaximin (n = 199) vs placebo (n = 208) were composite (45.7% vs 40.9%; P = 0.32), abdominal pain (50.3% vs 42.8%; P = 0.13), or stool consistency (77.4% vs 69.7%; P = 0.08) responders. In TARGET 2, a greater percentage of pts treated with rifaximin (n = 106) vs placebo (n = 97) in colonoscopy >60 d prior group were composite (45.3% vs 32.0%; P = 0.05), abdominal pain (53.8% vs 39.2%; P = 0.04), or stool consistency (71.7% vs 61.9%; P = 0.14) responders. A greater percentage of pts treated with rifaximin (n = 209) vs placebo (n = 223) in colonoscopy ≤60 d prior group were responders, although differences were smaller: composite (47.4% vs 38.1%; P = 0.05), abdominal pain (51.7% vs 44.8%; P = 0.16), and stool consistency (75.1% vs 65.5%; P = 0.03).

CONCLUSION:
Larger differences in responder rates with rifaximin vs placebo were observed in pts in whom colonoscopy was >60 d from start of IBS-D therapy. This may be related in part to reestablishment of IBS-related gut microbiota dysbiosis; further research is needed.
513 Recent Trends in Gastroenterology and Endoscopy Related Medical Professional Liability Claims in the United States of America
Authors: Jayaraj Mahendran , Makar Ranjit , Lankarani Daisy S. , Parikh Divya , Ohning Gordon 
Published: October 2019

INTRODUCTION:
In the recent years medical malpractice claims have contributed significantly to the rising cost of medical practice in all specialties in the United States by increasing the malpractice insurance premiums and costs associated with the practice of defensive medicine. Being a procedure oriented specialty, the trends in gastroenterology diagnoses and endoscopy related claims need to be studied to educate the gastroenterologists towards risk management.

METHODS:
Retrospective analysis of Medical professional liability (MPL) claims data for the years 2006-2015 obtained from the MPL association [formerly the Physician Insurers Association of America (PIAA) Data Sharing Project (DSP)] was done. Among the gastroenterology claims the presenting medical condition, operative procedure, outcomes of the claims and the costs associated with the closed claims were compared between 2006-2010 and 2011-2015 time periods to analyze the trend over the years.

RESULTS:
From 2006-2015, 90,743 MPL claims were closed . Out of all the claims, 2.07% (1879/90,743) of closed claims and 1.5% (367/24,106) of all paid claims were against gastroenterologists. In the claims against gastroenterologists, 71.0% of were dropped, withdrawn, or dismissed. Within the GI, MPL claims involving diagnostic procedures of large intestine were the most common accounting for 26% of all closed claims leading to a payment of $18,392,668 in total and $301,519 as average indemnity. Average indemnity was highest for diagnostic procedures of gallbladder and biliary tract including ERCP procedures ($484,364).This was followed by procedures involving small intestine ($336,078), large intestine ($301,519) and esophagus ($267,577). In the time frame 2006-2015, the average indemnity increased by 8.2% from $341,563 in 2006-2010 to $369,508 in 2011-2015. Amount spent on legal defense also increased by 8.7% ($44,625 vs. $48,506) in gastroenterology related claims for the respective time periods.

CONCLUSION:
Gastroenterology specialty has an increasing trend in spending on average indemnity and defense. Diagnostic procedures of the biliary tract including ERCP have the highest average indemnity among the endoscopic procedures. Adequate endoscopic training, meticulous focus on procedural indication and well informed consent might help to reduce the costs associated with claims. Further studies are needed to investigate the variables associated with this trend in gastroenterology.
514 Optimal Bacterial Surveillance Protocol for Duodenoscopes and Linear Echoendoscopes: A Comparison of Two Approaches
Authors: Lui Jennifer , Chapman Christopher C. , Waxman Irving , Siddiqui Uzma D. 
Published: October 2019

INTRODUCTION:
The complex design of the elevator mechanism in duodenoscopes has been recognized as a challenge for disinfection and previously implicated as a source of clinically significant bacterial transmission. Our group has also determined the potential for harboring bacteria in elevator-containing linear echoendoscopes (1). Despite increased awareness, there continues to be a lack of definitive guidelines for routine bacterial culturing protocols for these endoscopes. Our study aims to provide a bacterial culture protocol that is cost-effective, efficient, and accurate.

METHODS:
Consecutive duodenoscopes and linear echoendoscopes (Olympus; Center Valley, PA) used at a tertiary care center were reprocessed following hospital and manufacturer protocol and dried using an automatic machine. The following morning, these endoscopes were sequentially cultured for surveillance using two different protocols. The brush protocol consisted of suctioning and dispensing sterile water through the endoscope multiple times prior to brushing eight different components of the endoscope, costs $53.40 per culture, and takes an average of 15 minutes. The swab protocol consisted of using a flocked swab to sample above, below, and around the elevator mechanism while it was in mid-position, costs $32.04 per culture and takes 1 minute to perform.

RESULTS:
A total of 292 primary cultures were collected from 17 duodenoscopes and 8 linear echoendoscopes. Of these, 146 cultures were gathered using the brush method and 146 cultures using the swab method. No endoscopes tested positive using the brush method. Two cultures (1.4%) tested positive for Enterobacter cloacae bacteria using the swab method (one duodenoscope and one linear echoendoscope).

CONCLUSION:
In our pilot study data, the swab method appeared to be superior to the brush method when evaluating the presence of residual bacteria found on duodenoscopes and linear echoendoscopes. The swab method not only detected two positive cultures not found on the brush method. Furthermore, the brush method poses a risk for environmental contamination due to the increased duration of sampling. Based on our prior published data, the swab method could potentially save our center $26,529 and 290 nursing hours annually, supporting the use of the flocked swab methods. Further prospective studies in larger sample sizes are needed to validate optimal surveillance protocols for elevator containing endoscopes.
519 Differences in Quality of Life Between Patients With Functional Dyspepsia After Endoscopy With Empiric Treatment and Placebo
Authors: Mardjo Sumardjo , Bayupurnama Putut , Ratnasari Neneng 
Published: October 2019

INTRODUCTION:
Functional dyspepsia is a common health problem found in society. Few of multifactorial aspects which become the underlying cause of functional dyspepsia are anxiety and psychosocial problem. Endoscopy examination can display exact information to patient with functional dyspepsia and expected to increase patient's quality of life. It is still necessary to evaluate the advantages of endoscopy examination in improving patient's quality of life.

METHODS:
Randomized double blind controlled trial is conducted to compare between group of patient who have been given an empiric treatment and other who have been given a placebo for 2 weeks after underwent endoscopy examination in patient with functional dyspepsia. The primary outcome of this study is decrease of NDI-SF score on both of groups at the end of study which has been tested with MannWhitney test.

RESULTS:
NDI-SF score decreased significantly in group who had been given empiric treatment (P = 0.001) and with placebo (P = 0.002) two weeks after performed endoscopy. Declined numbers which appear between two groups are not significantly different (P = 0.396). Endoscopy can lower NDI-SF score in psychosocial and anxiety aspects in groups with empiric treatment (P > 0.01) and placebo (P > 0.05). declined numbers are not significantly different in both groups (P = 0.74).

CONCLUSION:
There is compelling improvement in quality of life of patients whom diagnosed with functional dyspepsia after endoscopy in both groups. These improvements are not significantly different between these groups. This study show the placebo effect of endoscopy on functional dyspepsia patient. Unsedated endoscopy procedure give a real time experience for patient. This provides an improvement in the psychosocial and anxiety components of the NDI-score which simultaneously improves the overall NDI-score. In the future, endoscopic examination can be the first line in the diagnosis and treatment of functional dyspepsia. This can occur because of the increasing number of endoscopic centers to rural hospitals. Other benefits that can be obtained from early endoscopy in functional dyspepsia is to be abble to better capture cases of anatomical abnormalities of the upper gastrointestinal tract.
524 Nurse-Administered Propofol Continuous Infusion Sedation (NAPCIS) for Colonoscopy in Difficult to Sedate Patients
Authors: Lee Hyun Seok , Kozarek Richard , Ross Andrew , Lin Otto S. 
Published: October 2019

INTRODUCTION:
Certain types of patients are considered difficult to sedate for colonoscopy using standard moderate sedation drugs such as midazolam and fentanyl. These include those with a history of alcohol abuse, those who regularly use marijuana, those taking high doses of opioids, and those suffering from post-traumatic stress disorder (PTSD). In the past, these types of potentially problematic patients were commonly referred for colonoscopy under general anesthesia. We recently demonstrated that Nurse-Administered Propofol Continuous Infusion Sedation (NAPCIS) is effective and safe for the sedation of healthy patients undergoing colonoscopy. NAPCIS confers the benefit of propofol-based sedation without the added expense for anesthesia professionals. Given the higher sedative potency of propofol compared to midazolam/fentanyl, NAPCIS may also be effective in difficult-to-sedate patients.

METHODS:
We retrospectively included patients from one of four difficult-to-sedate groups who had undergone NAPCIS colonoscopy: (1) Alcohol abusers; (2) Marijuana abusers; (3) Heavy opioid users and (4) PTSD sufferers, and compared against control patients who had undergone concurrent NAPCIS colonoscopy.

RESULTS:
Compared with the control group (n = 656), the marijuana group (n = 226) required higher mean doses (adjusted for subject weight) for both fentanyl (0.4 mcg/kg vs 0.6 mcg/kg; P < 0.001) and propofol (4.7 mg/kg vs 5.0 mg/kg; P = 0.025). The PTSD group (n = 67) required higher fentanyl dosages (0.4 mcg/kg vs 0.6 mcg/kg; P = 0.009). The alcohol (n = 22) and opioid groups (n = 133) showed no differences in sedative doses compared to controls. The procedural success rates for all 4 groups were uniformly high (98.6-100.0%) and similar to that seen in the controls (99.1%). Procedure times and recovery times were similar for all study and control groups. In the control group, there were 10 mild adverse events (mild desaturation, agitation due to undersedation or transient bradycardia). There was 1 case of mild desaturation each in the marijuana, PTSD and alcohol groups, 1 case of bradycardia in the opioid group and 1 case of hypotension in the marijuana group. Statistically, there were no differences in complication rates between the controls and the 4 study groups. There were no serious complications or deaths.

CONCLUSION:
NAPCIS is a safe and effective means of providing sedation for colonoscopy in difficult-to-sedate patients, most of whom would have been referred for general anesthesia if NAPCIS was unavailable.
530 Electrolyte Shifts of NER1006 Bowel Preparation for Colonoscopy in the Elderly Are Transient and Well-Tolerated
Authors: Epstein Michael S. , Lorenzen Sarah , Franklin Howard , Cash Brooks D. 
Published: October 2019

INTRODUCTION:
Bowel preparation safety is important, especially in the elderly. The 1L PEG-based bowel preparation NER1006 is indicated for colon cleansing in preparation for colonoscopy in adults. An analysis of data from a phase 3 randomized study was conducted, subgrouping patients by age (≤65 and >65 y).

METHODS:
Adults undergoing colonoscopy were randomly assigned to receive NER1006 or oral sodium sulfate (OSS; evening/morning split-dosing) with total minimum volume requirements of 64 oz (NER1006) and 96 oz (OSS). Safety assessments included monitoring adverse events (AEs) and clinical laboratory testing. Plasma electrolyte levels were measured at baseline, Day 2 (day of colonoscopy), Day 4 ± 1, and Day 9 ± 1. The safety population included all patients who received ≥1 study dose. Upper limit of normal cut-off values were 145 mmol/L (sodium), 105 mmol/L (chloride), and 5 mmol/L (potassium).

RESULTS:
The safety population included 262 (NER1006) and 265 (OSS) patients. Most patients were aged ≤65 y (NER1006, n=214; OSS, n = 217). In patients >65 y, the most common AEs were nausea (10.4%) and vomiting (8.3%) with NER1006 and decreased glomerular filtration rate (6.3%) with OSS. Mean baseline sodium levels were similar for NER1006 and OSS in patients ≤65 y (141 mmol/L) and >65 y (140 mmol/L). A greater percentage of patients >65 y with normal baseline sodium levels had high sodium levels ( >145 mmol/L) on Day 2 with NER1006 (48.9%) vs OSS (6.5%); shifts were transient and 93.5% of NER1006-treated patients had normal sodium levels by Day 4 (mean, 141 mmol/L). In patients ≤65 y in NER1006 group, 37.6% had a shift in sodium levels from normal at baseline to high at Day 2 (mean, 144.5 mmol/L) vs 3.7% with OSS; 90.9% of NER1006-treated patients had normal sodium levels by Day 4 (mean, 141.3 mmol/L). Chloride levels transiently increased from baseline in 27.7% (>65 y) and 19.2% (≤65 y) of patients at Day 2 with NER1006; 84.8% and 83.8% had normal levels by Day 4. At least 95% of NER1006-treated patients in both age groups had normal potassium levels from baseline through Day 9. Hyperuricemia was not reported in either age or treatment group. No electrolyte shifts resulted in clinical sequelae.

CONCLUSION:
NER1006 was generally well tolerated regardless of age. Transient increases in sodium and chloride levels were observed on the day of colonoscopy, but changes were not clinically meaningful and levels returned to normal in most patients by Day 4. Funding: Norgine BV/Salix Pharmaceuticals.
536 Adenoma Detection Rate Is Higher in a.m. Colonoscopies Only When Performed in Full-Day Blocks: A Systematic Review and Meta-Analysis
Authors: Nehme Fredy , Al Momani Laith , Zafar Yousaf , Alomari Mohammad , Elkafrawy Ahmed A. , King Connor 
Published: October 2019

INTRODUCTION:
Colorectal cancer (CRC) is the fourth leading cause of malignancy in the US. Colonoscopy remains the most accurate tool for CRC screening. Adenoma detection rate (ADR) and polyp detection rate (PDR) are important quality indicators for colonoscopy and high rates are associated with decreased post-colonoscopy CRC. Colonoscopy performed in the afternoon has been reported to be associated with lower rates of ADR and PDR, however studies remain controversial. Our aim was to perform a systematic review and meta-analysis to evaluate the ADR and PDR between morning and afternoon colonoscopies.

METHODS:
We included trials comparing ADR or PDR between morning (AM) and afternoon (PM) colonoscopies. We searched Medline, Google Scholar, and Cochrane through May 2019. Eligible studies were searched for variables of interest. All statistical analyses were performed using the R Programming Language. Pooled rates of variables were reported as Odds ratio (OR) with 95% confidence interval and heterogeneity was reported as I2statistics.

RESULTS:
A total of 14 trials were eligible and included in the analysis. Colonoscopies were performed in full-day blocks in 3 studies and in half-day blocks in 5. There was a total of 18184 subjects in the AM group and 12326 in the PM group. ADR and PDR were significantly higher in the AM compared to the PM group only when performed in full-day blocks (OR = 1.25, 1.11-1.4; OR = 1.33, 1.13-1.58 respectively). Bowel prep adequacy was similar between the 2 groups (OR = 1.08, 0.8-1.45). There was substantial heterogeneity.

CONCLUSION:
Colonoscopy quality, as indicated by ADR and PDR is only affected when performing colonoscopies in full-day blocks with lower performance in the afternoon. Endoscopist fatigue, fellow participation and quality of bowel prep are important cofounders when comparing quality metrics in endoscopy. The difference between in ADR and PDR between studies is likely multifactorial, however scheduling colonoscopies in half-day shifts may prevent endoscopist fatigue and improve performance. Given the heterogeneity of the results, definite conclusions cannot be drawn and future randomized trials are needed.