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https://www.readbyqxmd.com/read/27639346/resolving-the-physiological-conditions-in-bioavailability-and-bioequivalence-studies-comparison-of-fasted-and-fed-state
#1
Felix Schneider, Michael Grimm, Mirko Koziolek, Christiane Modeß, Anne Dokter, Tarek Roustom, Werner Siegmund, Werner Weitschies
In the present study temperature, pH and pressure profiles of nine healthy human volunteers were investigated after ingestion of the SmartPill® under conditions simulating the fasted state treatment in bioavailability and bioequivalence studies. In a previously published study the same subjects received the SmartPill® under fed conditions as recommended by the FDA. Since large non-digestible objects are mainly emptied during phase III of the interdigestive migrating motor complex, the gastric residence time of the SmartPill® was found to be clearly shorter under fasting conditions...
September 14, 2016: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/27401360/smartpill%C3%A2-as-an-objective-parameter-for-determination-of-severity-and-duration-of-postoperative-ileus-study-protocol-of-a-prospective-two-arm-open-label-trial-the-pidusa-study
#2
Tim O Vilz, Dimitrios Pantelis, Philipp Lingohr, Rolf Fimmers, Anke Esmann, Thomas Randau, Jörg C Kalff, Martin Coenen, Sven Wehner
INTRODUCTION: Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill(®), a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo...
July 8, 2016: BMJ Open
https://www.readbyqxmd.com/read/27092333/morpho-functional-evaluation-of-small-bowel-using-wireless-motility-capsule-and-video-capsule-endoscopy-in-patients-with-known-or-suspected-crohn-s-disease-pilot-study
#3
Diana Yung, Sarah Douglas, Anthony R Hobson, Andry Giannakou, John N Plevris, Anastasios Koulaouzidis
BACKGROUND AND STUDY AIMS: SmartPill(®) (Given Imaging Corp.,Yoqneam,Israel) is an ingestible, non-imaging capsule that records physiological data including contractions and pH throughout the gastrointestinal tract. There are scarce data looking at SmartPill(®) assessment of patients with known/suspected small-bowel Crohn's Disease (CD). This pilot study aims to investigate feasibility and safety of SmartPill(®) to assess gut motility in this group.  PATIENTS AND METHODS: Over 1 year, patients with known/suspected CD, referred for small-bowel capsule endoscopy (SBCE), were invited to participate and 12 were recruited (7 female, 5 male, mean age 44...
April 2016: Endoscopy International Open
https://www.readbyqxmd.com/read/27070390/-not-available
#4
Hetzel Diaz, Ulrika Sjöström, Greger Lindberg, Per M Hellström
The wireless motility-recording capsule, "SmartPill", is an ingested one-time use electronic capsule that measures gastrointestinal luminal pressure, pH and temperature along the whole gastrointestinal tract. The pH profile and the pressure patterns define the time at which the capsule moves from the stomach to the duodenum and from the ileum to the caecum, whereas changes in temperature define the times of ingestion and expulsion. The recordings from the wireless motility capsule are sent from a radio transmitter in the capsule to a receiver carried around the waist...
2016: Läkartidningen
https://www.readbyqxmd.com/read/26629926/assessment-of-the-effect-of-intestinal-permeability-probes-lactulose-and-mannitol-and-other-liquids-on-digesta-residence-times-in-various-segments-of-the-gut-determined-by-wireless-motility-capsule-a-randomised-controlled-trial
#5
RANDOMIZED CONTROLLED TRIAL
Ivana R Sequeira, Roger G Lentle, Marlena C Kruger, Roger D Hurst
BACKGROUND: Whilst the use of the mannitol/lactulose test for intestinal permeability has been long established it is not known whether the doses of these sugars modify transit time Similarly it is not known whether substances such as aspirin that are known to increase intestinal permeability to lactulose and mannitol and those such as ascorbic acid which are stated to be beneficial to gastrointestinal health also influence intestinal transit time. METHODS: Gastric and intestinal transit times were determined with a SmartPill following consumption of either a lactulose mannitol solution, a solution containing 600 mg aspirin, a solution containing 500 mg of ascorbic acid or an extract of blackcurrant, and compared by doubly repeated measures ANOVA with those following consumption of the same volume of a control in a cross-over study in six healthy female volunteers...
2015: PloS One
https://www.readbyqxmd.com/read/26476174/intragastric-ph-and-pressure-profiles-after-intake-of-the-high-caloric-high-fat-meal-as-used-for-food-effect-studies
#6
M Koziolek, F Schneider, M Grimm, Chr Modeβ, A Seekamp, T Roustom, W Siegmund, W Weitschies
The intraluminal conditions of the fed stomach are critical for drug release from solid oral dosage forms and thus, often associated with the occurrence of food effects on oral bioavailability. In this study, intragastric pH and pressure profiles present after the ingestion of the high-caloric, high-fat (964 kcal) FDA standard breakfast were investigated in 19 healthy human subjects by using the telemetric SmartPill® capsule system (26 × 13 mm). Since the gastric emptying of such large non-digestible objects is typically accomplished by the migrating motor complex phase III activity, the time required for recurrence of fasted state motility determined the gastric emptying time (GET)...
December 28, 2015: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/26303129/altered-colonic-bacterial-fermentation-as-a-potential-pathophysiological-factor-in-irritable-bowel-syndrome
#7
Tamar Ringel-Kulka, Chang Hwan Choi, Daniel Temas, Ari Kim, Daniele M Maier, Karen Scott, Joseph A Galanko, Yehuda Ringel
OBJECTIVES: Dysbiosis leading to abnormal intestinal fermentation has been suggested as a possible etiological mechanism in irritable bowel syndrome (IBS). We aimed to investigate the location and magnitude of altered intestinal bacterial fermentation in IBS and its clinical subtypes. METHODS: IBS patients who satisfied the Rome III criteria (114) and 33 healthy controls (HC) were investigated. Intestinal fermentation was assessed using two surrogate measures: intestinal intraluminal pH and fecal short-chain fatty acids (SCFAs)...
September 2015: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/26158610/assessment-of-tandem-measurements-of-ph-and-total-gut-transit-time-in-healthy-volunteers
#8
Adam E Mikolajczyk, Sydeaka Watson, Bonnie L Surma, David T Rubin
OBJECTIVES: The variation of luminal pH and transit time in an individual is unknown, yet is necessary to interpret single measurements. This study aimed to assess the intrasubject variability of gut pH and transit time in healthy volunteers using SmartPill devices (Covidien, Minneapolis, MN). METHODS: Each subject (n=10) ingested two SmartPill devices separated by 24 h. Mean pH values were calculated for 30 min after gastric emptying (AGE), before the ileocecal (BIC) valve, after the ileocecal (AIC) valve, and before body exit (BBE)...
2015: Clinical and Translational Gastroenterology
https://www.readbyqxmd.com/read/25319735/small-intestinal-transit-time-is-delayed-in-small-intestinal-bacterial-overgrowth
#9
Bani Chander Roland, Maria M Ciarleglio, John O Clarke, John R Semler, Eric Tomakin, Gerard E Mullin, Pankaj J Pasricha
BACKGROUND: Altered small intestinal motility is thought to contribute to the development of small intestinal bacterial overgrowth (SIBO). The clinical manifestations of SIBO and consequent malabsorption are wide ranging and include abdominal pain, bloating, diarrhea, weight loss, and nutritional deficiencies. However, due to the nonspecific nature of symptoms, the diagnosis may often be overlooked. To date, few studies have illustrated a direct relationship between impaired small intestinal motility and SIBO...
August 2015: Journal of Clinical Gastroenterology
https://www.readbyqxmd.com/read/24901524/standardising-the-lactulose-mannitol-test-of-gut-permeability-to-minimise-error-and-promote-comparability
#10
Ivana R Sequeira, Roger G Lentle, Marlena C Kruger, Roger D Hurst
BACKGROUND: Lactulose mannitol ratio tests are clinically useful for assessing disorders characterised by changes in gut permeability and for assessing mixing in the intestinal lumen. Variations between currently used test protocols preclude meaningful comparisons between studies. We determined the optimal sampling period and related this to intestinal residence. METHODS: Half-hourly lactulose and mannitol urinary excretions were determined over 6 hours in 40 healthy female volunteers after administration of either 600 mg aspirin or placebo, in randomised order at weekly intervals...
2014: PloS One
https://www.readbyqxmd.com/read/24881810/the-use-of-smartpill-for-gastric-monitoring
#11
REVIEW
William L Hasler
Testing to define delayed gastric emptying is required to diagnose gastroparesis; rapid emptying is found in other patients. Commonly performed methods of gastric emptying testing include scintigraphy and breath testing. The SmartPill wireless motility capsule (WMC) system is US FDA-approved for evaluating suspected delayed emptying in gastroparesis and functional dyspepsia. The device measures transit in the stomach, small intestine, and colon by detecting characteristic pH transitions; and quantifies pressure waves in each gut region...
August 2014: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/24503633/motility-abnormalities-in-irritable-bowel-syndrome
#12
Andrew W DuPont, Zhi-Dong Jiang, Stephen A Harold, Ned Snyder, Greg W Galler, Francisco Garcia-Torres, Herbert L DuPont
BACKGROUND/AIMS: The intestinal pathophysiology in irritable bowel syndrome (IBS) is largely unknown. The lactulose breath test has been used to identify small bowel bacterial overgrowth in these patients. METHODS: We studied intestinal transit in patients with IBS using of the SmartPill® (SP) wireless pH/pressure recording capsule and performed lactulose breath tests to look for physiologic abnormalities. RESULTS: A total of 35/46 (76%) of the IBS patients had prolonged gastric emptying times...
2014: Digestion
https://www.readbyqxmd.com/read/23639004/a-new-method-for-determining-gastric-acid-output-using-a-wireless-ph-sensing-capsule
#13
D H Weinstein, S deRijke, C C Chow, L Foruraghi, X Zhao, E C Wright, M Whatley, R Maass-Moreno, C C Chen, S A Wank
BACKGROUND: Gastro-oesophageal reflux disease (GERD) and gastric acid hypersecretion respond well to suppression of gastric acid secretion. However, clinical management and research in diseases of acid secretion have been hindered by the lack of a non-invasive, accurate and reproducible tool to measure gastric acid output (GAO). Thus, symptoms or, in refractory cases, invasive testing may guide acid suppression therapy. AIM: To present and validate a novel, non-invasive method of GAO analysis in healthy subjects using a wireless pH sensor, SmartPill (SP) (SmartPill Corporation, Buffalo, NY, USA)...
June 2013: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/23632359/decompensated-cirrhotics-have-slower-intestinal-transit-times-as-compared-with-compensated-cirrhotics-and-healthy-controls
#14
Bani Chander Roland, Guadalupe Garcia-Tsao, Maria M Ciarleglio, Yanhong Deng, Anish Sheth
BACKGROUND: Altered small intestinal motility in cirrhotics may play a major role in the development of bacterial translocation (BT) by leading to small intestinal bacterial overgrowth. BT has been implicated in the development of several complications including spontaneous bacterial peritonitis, esophageal variceal hemorrhage, and hepatorenal syndrome. Prior studies using antroduodenal manometry to evaluate intestinal motility have shown discrepancies regarding the relationship between dysmotility and the severity of cirrhosis...
November 2013: Journal of Clinical Gastroenterology
https://www.readbyqxmd.com/read/23589143/use-of-a-high-caloric-liquid-meal-as-an-alternative-to-a-solid-meal-for-gastric-emptying-scintigraphy
#15
RANDOMIZED CONTROLLED TRIAL
Priyanka Sachdeva, Steven Kantor, Linda C Knight, Alan H Maurer, Robert S Fisher, Henry P Parkman
BACKGROUND: Gastric emptying scintigraphy (GES) using a solid meal is often recommended for the evaluation of gastroparesis. However, some patients cannot tolerate the standardized egg-white sandwich (EWS) solid meal and an alternative meal is needed. AIM: The aim of this study was to compare GES, regional gastric emptying, and gastric contractility using a liquid nutrient meal (LNM; Ensure Plus(®)) to those using EWS. METHODS: Twenty healthy volunteers underwent GES using EWS and LNM on separate days...
July 2013: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/22778790/evaluation-of-regional-and-whole-gut-motility-using-the-wireless-motility-capsule-relevance-in-clinical-practice
#16
Khoa Tran, Rita Brun, Braden Kuo
The wireless motility capsule (WMC) is an ambulatory noninvasive and nonradioactive diagnostic sensor that continuously samples intraluminal pH, temperature, and pressure as it moves through the gastrointestinal (GI) tract. This review summarizes the data obtained in clinical trials with the WMC and discusses its role in clinical practice. The United States Food and Drug Administration has approved the SmartPill GI monitoring system for the evaluation of gastric emptying time in patients with suspected gastroparesis, the evaluation of colonic transit time in patients with suspected chronic constipation, and for the characterization of pressure profiles from the antrum and duodenum...
July 2012: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/22296404/evaluation-of-a-wireless-ambulatory-capsule-smartpill%C3%A2-to-measure-gastrointestinal-tract-ph-luminal-pressure-and-temperature-and-transit-time-in-ponies
#17
A M Stokes, N L Lavie, M L Keowen, L Gaschen, F P Gaschen, D Barthel, F M Andrews
REASONS FOR PERFORMING STUDY: This study investigated the use of a wireless ambulatory capsule (WAC; SmartPill(®) pH.p GI Monitoring System) to determine WAC-gastric emptying time (GET) in ponies. OBJECTIVES: To measure WAC-GET and compare it to those findings with GET assessed by nuclear scintigraphy (S-GET). HYPOTHESIS: WAC-GET will be slower than S-GET, but will be significantly correlated. METHODS: Seven healthy adult mixed-breed pony mares were used in this study...
July 2012: Equine Veterinary Journal
https://www.readbyqxmd.com/read/21940390/a-new-non-invasive-modality-for-recording-sequential-images-and-the-ph-of-the-small-bowel
#18
Hiroshi Iida, Hiroki Endo, Yusuke Sekino, Eiji Sakai, Takashi Uchiyama, Kunihiro Hosono, Takashi Nonaka, Yasunari Sakamoto, Koji Fujita, Masato Yoneda, Tomoko Koide, Hirokazu Takahashi, Chikako Tokoro, Ayumu Goto, Yasunobu Abe, Eiji Gotoh, Shin Maeda, Atsushi Nakajima, Masahiko Inamori
BACKGROUND/AIMS: Before the introduction of capsule endoscopy and double-balloon endoscopy, there were no effective modalities for reliable evaluation of the small bowel. Recently, the SmartPill, a wireless pH/ pressure recording capsule, has been utilized to measure the whole gut transit time. However, there are few studies on the small bowel pH. The aim of this study was to investigate the relationship between small bowel disease and the small bowel pH, we designed a new modality, the 'pH capsule', to non-invasively record sequential images and the pH...
March 2012: Hepato-gastroenterology
https://www.readbyqxmd.com/read/21876549/smartpill-technology-provides-safe-and-effective-assessment-of-gastrointestinal-function-in-persons-with-spinal-cord-injury
#19
COMPARATIVE STUDY
R E Williams, W A Bauman, A M Spungen, R R Vinnakota, R Z Farid, M Galea, M A Korsten
STUDY DESIGN: Spinal cord injury (SCI) results in gastrointestinal (GI) complications, including gastroesophageal reflux disease and constipation, but much of the data is based on older technology. OBJECTIVE: GI transit times were determined in subjects with SCI using a new device called a SmartPill. Our principal goal was to assess whether this new technology can be applied in persons with SCI. METHODS: SCI and age- and gender-matched able-bodied (AB) control subjects not taking proton pump inhibitors were studied...
January 2012: Spinal Cord
https://www.readbyqxmd.com/read/21435365/feasibility-of-measuring-gastric-emptying-time-with-a-wireless-motility-device-after-subjects-consume-fiber-matched-liquid-and-solid-breakfasts
#20
RANDOMIZED CONTROLLED TRIAL
Holly J Willis, William Thomas, David J Willis, Joanne L Slavin
To explore the feasibility and sensitivity of a new technology for measuring gastric emptying time (GET) in appetite research, and also to compare appetite after subjects consumed macronutrient- and fiber-matched liquid and solid meals. Fourteen women (BMI of 21.2 ± 0.3) participated in this randomized, crossover study. On two separate days, fasted subjects consumed liquid (fruit juices and skim milk) and solid (oatmeal, blueberries, and apples) breakfasts. Both meals had 10 g of fiber and 410 kcal. GET was assessed with the SmartPill GI Motility System®, appetite was assessed with visual analog scales, and food intake was measured at lunch...
August 2011: Appetite
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