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RANDOMIZED CONTROLLED TRIAL
Satish S C Rao, Eamonn M M Quigley, William D Chey, Amol Sharma, Anthony J Lembo
BACKGROUND & AIMS: Despite therapeutic advances, effective treatments for chronic constipation remain an unmet need. The vibrating capsule is a nonpharmacologic, orally ingested, programmable capsule that vibrates intraluminally to induce bowel movements. We aimed to determine the efficacy and safety of the vibrating capsule in patients with chronic constipation. METHODS: We conducted a phase 3, double-blind, placebo-controlled trial of patients with chronic constipation, who were randomized to receive either a vibrating or placebo capsule, once daily, 5 days a week for 8 weeks...
June 2023: Gastroenterology
#22
JOURNAL ARTICLE
Lin Chang, Brooks D Cash, Anthony Lembo, David C Kunkel, Brett A English, Beatriz Lindstrom, Guibao Gu, Sharon Skare, Kye Gilder, Stewart Turner, Fabio Cataldi, Donald Lipkis, Tack Jan
BACKGROUND: Olorinab is a highly selective, peripherally acting, full agonist of cannabinoid receptor 2. This study assessed the efficacy and safety of olorinab to treat abdominal pain in patients with irritable bowel syndrome with diarrhea (IBS-D) and constipation (IBS-C). METHODS: CAPTIVATE was a phase 2b, randomized, double-blind, placebo-controlled, parallel-group trial. Eligible participants aged 18-70 years with IBS-C and IBS-D diagnosed per Rome IV received olorinab 10 mg, 25 mg, or 50 mg three times daily (TID) or placebo TID for 12 weeks...
February 5, 2023: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
#23
JOURNAL ARTICLE
Emily V Wechsler, Nitin K Ahuja, Darren Brenner, Walter Chan, Lin Chang, William D Chey, Anthony J Lembo, Baha Moshiree, Judy Nee, Shailja C Shah, Kyle Staller, Eric D Shah
BACKGROUND & AIMS: Practice guidelines promote a routine noninvasive, non-endoscopic initial approach to investigating dyspepsia without alarm features in young patients, yet many patients undergo prompt upper endoscopy. We aimed to assess tradeoffs among costs, patient satisfaction, and clinical outcomes to inform discrepancy between guidelines and practice. METHODS: We constructed a decision-analytic model and performed cost-effectiveness/cost-satisfaction analysis over a 1-year time horizon on patients with uninvestigated dyspepsia without alarm features referred to gastroenterology...
January 13, 2023: Clinical Gastroenterology and Hepatology
#24
JOURNAL ARTICLE
Longbin Liu, Peter D Johnson, Michael E Prime, Vinod Khetarpal, Christopher J Brown, Luca Anzillotti, Daniele Bertoglio, Xuemei Chen, Samuel Coe, Randall Davis, Anthony P Dickie, Simone Esposito, Elise Gadouleau, Paul R Giles, Catherine Greenaway, James Haber, Christer Halldin, Scott Haller, Sarah Hayes, Todd Herbst, Frank Herrmann, Manuela Heßmann, Ming Min Hsai, Yaser Khani, Adrian Kotey, Angelo Lembo, John E Mangette, Gwendolyn A Marriner, Richard W Marston, Matthew R Mills, Edith Monteagudo, Anton Forsberg-Morén, Sangram Nag, Laura Orsatti, Christine Sandiego, Sabine Schaertl, Joanne Sproston, Steven Staelens, Jack Tookey, Penelope A Turner, Andrea Vecchi, Maria Veneziano, Ignacio Muñoz-Sanjuan, Jonathan Bard, Celia Dominguez
Therapeutic interventions are being developed for Huntington's disease (HD), a hallmark of which is mutant huntingtin protein (mHTT) aggregates. Following the advancement to human testing of two [11 C]-PET ligands for aggregated mHTT, attributes for further optimization were identified. We replaced the pyridazinone ring of CHDI-180 with a pyrimidine ring and minimized off-target binding using brain homogenate derived from Alzheimer's disease patients. The major in vivo metabolic pathway via aldehyde oxidase was blocked with a 2-methyl group on the pyrimidine ring...
January 12, 2023: Journal of Medicinal Chemistry
#25
JOURNAL ARTICLE
Anthony Lembo, Braden Kuo, Ramesh Boinpally, Ella Li, Madhuja Mallick, Wieslaw Bochenek, Wilmin Bartolini
BACKGROUND: MD-7246, a delayed-release formulation of linaclotide, is designed to target the ileocaecal junction and caecum with the aim of relieving abdominal pain independently of bowel function. AIMS: To evaluate the efficacy, safety and dose-response of MD-7246 in patients with irritable bowel syndrome with diarrhoea (IBS-D). METHODS: A randomised, double-blind, phase 2 clinical trial enrolled adult patients with IBS-D (Rome IV criteria)...
November 2, 2022: Alimentary Pharmacology & Therapeutics
#26
JOURNAL ARTICLE
Hyder Said, Judy Nee, Johanna Iturrino, Vikram Rangan, Prashant Singh, Anthony Lembo, Sarah Ballou
BACKGROUND: The estimated prevalence of bloating is 15 to 30% in the adult US population and is even higher in patients with disorders of gut-brain interaction (DGBIs). Despite this frequency, there is little research into patients who endorse bloating as a predominant symptom. The aim of this study was to better characterize these patients. MATERIALS AND METHODS: New patients with DGBIs were asked to identify their 3 most predominant symptoms over the preceding 3 months; those who reported bloating were classified as "bloating predominant...
October 31, 2022: Journal of Clinical Gastroenterology
#27
JOURNAL ARTICLE
Stacy B Menees, Anthony Lembo, Aline Charabaty
No abstract text is available yet for this article.
October 1, 2022: American Journal of Gastroenterology
#28
RANDOMIZED CONTROLLED TRIAL
Stacy B Menees, Anthony J Lembo, William D Chey
METHODS: This multicenter, double-blind, placebo-controlled, parallel-group trial included adults with chronic idiopathic constipation randomized to polyethylene glycol 3350 17 g ( n = 204) or placebo ( n = 100) once daily for 24 weeks. Post hoc analyses were performed using the US Food and Drug Administration endpoint (≥3 complete spontaneous bowel movements/week and an increase of ≥1 complete spontaneous bowel movement/week from baseline for ≥9/12 weeks, including 3 of the last 4 weeks) along with additional efficacy and safety outcomes...
2022: Canadian Journal of Gastroenterology & Hepatology
#29
JOURNAL ARTICLE
Kyle Staller, Anthony Lembo, Aleena Banerji, Jonathan A Bernstein, Eric D Shah, Marc A Riedl
Health care providers are likely to encounter patients with recurrent unexplained abdominal pain. Because hereditary angioedema (HAE) is a rare disease, it may not be part of the differential diagnosis, especially for patients who do not have concurrent skin swelling in addition to abdominal symptoms. Abdominal pain is very common in patients with HAE, occurring in up to 93% of patients, with recurrent abdominal pain reported in up to 80% of patients. In 49% of HAE attacks with abdominal symptoms, isolated abdominal pain was the only symptom...
October 1, 2022: Journal of Clinical Gastroenterology
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JOURNAL ARTICLE
Vikram Rangan, Judy Nee, Brian Li, Anthony J Lembo, David A Leiman
INTRODUCTION: Ineffective esophageal motility (IEM) is the most common motility disorder identified on esophageal high-resolution manometry (HRM), but patients with this finding may be asymptomatic. Therefore, we aimed to identify specific HRM findings predictive of symptoms in IEM. METHODS: Adult patients (≥18 y) who underwent HRM between March 2016 and July 2019 were retrospectively evaluated and reclassified according to Chicago Classification 4.0 (CC4.0)...
August 15, 2022: Journal of Clinical Gastroenterology
#31
JOURNAL ARTICLE
Maria Rosa Ingrosso, Gianluca Ianiro, Judy Nee, Anthony J Lembo, Paul Moayyedi, Christopher J Black, Alexander C Ford
BACKGROUND: Irritable bowel syndrome (IBS) is one of the most common disorders of gut-brain interaction, with a complex pathophysiology. Antispasmodics are prescribed as first-line therapy because of their action on gut dysmotility. In this regard, peppermint oil also has antispasmodic properties. AIM: To update our previous meta-analysis to assess efficacy and safety of peppermint oil, particularly as recent studies have cast doubt on its role in the treatment of IBS METHODS: We searched the medical literature up to 2nd April 2022 to identify randomised controlled trials (RCTs) of peppermint oil in IBS...
September 2022: Alimentary Pharmacology & Therapeutics
#32
JOURNAL ARTICLE
Anthony Lembo, Shahnaz Sultan, Lin Chang, Joel J Heidelbaugh, Walter Smalley, G Nicholas Verne
BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder associated with significant disease burden. This American Gastroenterological Association Guideline is intended to support practitioners in decisions about the use of medications for the pharmacological management of IBS with predominant diarrhea (IBS-D) and is an update of a prior technical review and guideline. METHODS: The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and make recommendations...
July 2022: Gastroenterology
#33
JOURNAL ARTICLE
Lin Chang, Shahnaz Sultan, Anthony Lembo, G Nicholas Verne, Walter Smalley, Joel J Heidelbaugh
BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction associated with significant disease burden. This American Gastroenterological Association guideline is intended to support practitioners in decisions about the use of medications for the pharmacological management of IBS-C and is an update of a prior technical review and guideline. METHODS: The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and make recommendations...
July 2022: Gastroenterology
#34
RANDOMIZED CONTROLLED TRIAL
Sarah Ballou, Julia W Haas, Johanna Iturrino, Judy Nee, Irving Kirsch, Vikram Rangan, Vivian Cheng, Anthony Lembo, Ted J Kaptchuk, John M Kelley
OBJECTIVE: There is growing evidence that open-label placebo (OLP) may be an efficacious treatment of chronic and functional conditions. However, patient-level predictors of response to OLP have not been clearly identified. The aim of this study is to evaluate the psychological predictors of response to OLP and to compare this to double-blind placebo (DBP) and no-pill control (NPC). METHODS: This study is a secondary analysis of data collected in a 6-week randomized controlled trial evaluating placebo effects in irritable bowel syndrome (IBS)...
July 2022: Psychosomatic Medicine
#35
JOURNAL ARTICLE
Jan Vollert, Ruisheng Wang, Stephanie Regis, Hailey Yetman, Anthony J Lembo, Ted J Kaptchuk, Vivian Cheng, Judy Nee, Johanna Iturrino, Joseph Loscalzo, Kathryn T Hall, Jocelyn A Silvester
Background: Irritable bowel syndrome (IBS) is a highly prevalent chronic pain disorder with multiple underlying mechanisms and few treatments that have been demonstrated to be effective in placebo controlled trials. One potential reason may be the use of composite outcomes, such as the IBS Symptom Severity Scale (IBS-SSS) which includes descriptive items related to pain frequency and pain intensity as well as bowel dysfunction and bloating. We investigated if different features of IBS pain have distinct genetic associations and if these may be moderated by sex hormones...
2022: Frontiers in Psychiatry
#36
JOURNAL ARTICLE
Sarah Ballou, Rafla Hassan, Judy Nee, Johanna Iturrino, Vikram Rangan, Vivian Cheng, Lisa Conboy, Irving Kirsch, Anthony Lembo, Ted J Kaptchuk, John Kelley
BACKGROUND & AIMS: Many of the reported adverse events in clinical trials of irritable bowel syndrome are extraintestinal symptoms, which typically are assessed by open-ended questions during the trial and not at baseline. This may lead to misattribution of some pre-existing symptoms as side effects to the treatment. METHODS: The current study analyzed data from a 6-week clinical trial of irritable bowel syndrome. Participants were randomized to receive double-blind peppermint oil, double-blind placebo, or treatment as usual...
March 23, 2022: Clinical Gastroenterology and Hepatology
#37
RANDOMIZED CONTROLLED TRIAL
Julia W Haas, Giulio Ongaro, Eric Jacobson, Lisa A Conboy, Judy Nee, Johanna Iturrino, Vikram Rangan, Anthony Lembo, Ted J Kaptchuk, Sarah Ballou
BACKGROUND: There is increasing evidence suggesting that open-label placebo (OLP) is an effective treatment for several medical conditions defined by self-report. However, little is known about patients' experiences with OLP, and no studies have directly compared patients' experiences in double-blind placebo (DBP) conditions. METHODS: This study was nested in a large randomized-controlled trial comparing the effects of OLP and DBP treatments in individuals with irritable bowel syndrome (IBS)...
February 4, 2022: BMC Psychology
#38
RANDOMIZED CONTROLLED TRIAL
Prashant Singh, Eric J Alm, John M Kelley, Vivian Cheng, Mark Smith, Zain Kassam, Judy Nee, Johanna Iturrino, Anthony Lembo
Fecal microbiota transplantation (FMT) is an attractive strategy to correct microbial dysbiosis in diarrhea-predominant irritable bowel syndrome (IBS-D). Although the mechanism of FMT is thought to be bacterial engraftment, the best approach to achieve engraftment after FMT in IBS-D (and other diseases) is not clear. We evaluated the effect of FMT (with or without pretreatment with antibiotics) on gut microbiome and symptoms in patients with IBS-D. In this randomized, placebo-controlled, single-center study, 44 patients with IBS-D with a least moderate severity (IBS severity scoring system, i...
January 2022: Gut Microbes
#39
REVIEW
Judy Nee, Anthony Lembo
BACKGROUND: Irritable bowel syndrome-diarrhoea (IBS-D) and IBS-mixed stool pattern (IBS-M) are disorders of gut-brain interaction characterised by abdominal pain associated with diarrhoea or both diarrhoea and constipation respectively. The pathophysiology of IBS-D/M is multifactorial and not completely understood; thus, treatment is aimed at multiple mechanisms such as altering gut microbiota, visceral hypersensitivity, intestinal permeability, gut-brain interaction and psychological strategies...
December 2021: Alimentary Pharmacology & Therapeutics
#40
JOURNAL ARTICLE
Daniella Rastelli, Ariel Robinson, Valentina N Lagomarsino, Lynley T Matthews, Rafla Hassan, Kristina Perez, William Dan, Peter D Yim, Madison Mixer, Aleksandra Prochera, Amy Shepherd, Liang Sun, Kathryn Hall, Sarah Ballou, Anthony Lembo, Judy Nee, Meenakshi Rao
Functional gastrointestinal disorders (FGIDs) have prominent sex differences in incidence, symptoms, and treatment response that are not well understood. Androgens are steroid hormones present at much higher levels in males than females and could be involved in these differences. In adults with irritable bowel syndrome (IBS), a FGID that affects 5% to 10% of the population worldwide, we found that free testosterone levels were lower than those in healthy controls and inversely correlated with symptom severity...
January 18, 2022: Journal of Clinical Investigation
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