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Long-Term Efficacy and Safety of Fecal Microbiota Transplantation for C. difficile Infections Across Academic and Private Clinical Settings

Dogra, Siddhant; Oneto, Caterina; Sherman, Alex; Varughese, Resmi; Yuen, Alexa; Sherman, Isabel; Cohen, Avi; Luo, Yuying; Chen, Lea Ann
PURPOSE/OBJECTIVE:Fecal microbiota transplant (FMT) is increasingly performed for Clostridioides difficile infection (CDI), although long-term efficacy and safety data are limited and are focused on results from academic medical centers rather than private settings where most patients receive care. METHODS:Medical records of 165 patients who received FMTs for CDI were reviewed from an academic medical center and an adjacent, unaffiliated private practice. Of these patients, 68 also completed a survey regarding their long-term disease course and interval health. RESULTS:CDI resolution occurred in 81.3% (100/123) at the academic center and 95.2% (40/42) in the private setting. Private practice patients were more likely to present with recurrent, rather than refractory, CDI (92.9% vs. 66.7% P<0.001). Those from the academic center were more likely to have comorbid IBD, recent hospitalization, recent proton pump inhibitor use, ongoing immunosuppression, and inpatient FMT (all P values <0.05).Among surveyed patients, 29.4% developed interval comorbidities or changes to pre-existing conditions after a median follow-up of 33.7 months (IQR 13.2 to 44.3 mo). Of 30 patients requiring subsequent antibiotics, 13.3% suffered CDI relapse. All subjects who had initially responded to FMT but had a subsequent CDI (17.9%, 10/56) responded to another FMT. CONCLUSIONS:In a real-world setting, patients who underwent FMT at academic centers differed significantly in clinical characteristics from those treated at a private practice. In both settings, FMT is an effective treatment for CDI not responding to standard therapies, even after subsequent antibiotic use. New diagnoses following FMT, however, are common and merit further exploration.
PMID: 36227005
ISSN: 1539-2031
CID: 5361042

Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial

Aroniadis, Olga C; Brandt, Lawrence J; Oneto, Caterina; Feuerstadt, Paul; Sherman, Alex; Wolkoff, Allan W; Kassam, Zain; Sadovsky, Rotem Gura; Elliott, Ryan J; Budree, Shrish; Kim, Mimi; Keller, Marla J
BACKGROUND:Faecal microbiota transplantation (FMT) has shown promise in alleviating the symptoms of irritable bowel syndrome (IBS); however, controlled data on this technique are scarce. The aim of this clinical trial was to assess the efficacy of FMT in alleviating diarrhoea-predominant IBS (IBS-D). METHODS:We did a double-blind, randomised, placebo-controlled crossover trial in patients aged 18-65 years with moderate-to-severe IBS-D defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175, recruited from three US centres. Patients were randomly assigned (1:1) in blocks of four with a computer-generated randomisation sequence to receive FMT capsules followed by identical-appearing placebo capsules, or placebo capsules followed by FMT capsules. All participants and study team members were masked to randomisation. An independent staff member assigned the treatments according to consecutive numbers. Patients received either 75 FMT capsules (each capsule contained approximately 0·38 g of minimally processed donor stool) or 75 placebo capsules over 3 days (25 capsules per day). All patients crossed over to the alternate treatment at 12 weeks. The primary outcome was difference in IBS-SSS between the groups at 12 weeks. Intention-to-treat analyses were done and all patients who received study drug were included in an adverse events analysis. The trial was terminated during recruitment because results from an interim analysis revealed futility. The study is registered with, number NCT02328547. FINDINGS/RESULTS:From May 28, 2015, to April 21, 2017, 48 patients were randomly assigned to receive FMT first (n=25) or placebo first (n=23). Three participants were lost to follow-up in the FMT group. IBS-SSS did not differ between FMT recipients (mean 221 [SD 105]) and placebo recipients (236 [95]) at 12 weeks (p=0·65), after adjustment for baseline scores. The most common drug-related adverse events included abdominal pain (five [10%] of the 48 participants while receiving FMT capsules vs four [8%] while receiving placebo), nausea (four [8%] vs two [4%]), and exacerbation of diarrhoea (three [6%] vs eight [17%]). One serious adverse event that was unrelated to study drug (acute cholecystitis) was reported in a patient while receiving placebo capsules. INTERPRETATION/CONCLUSIONS:FMT was safe, but did not induce symptom relief at 12 weeks compared with placebo. Additional studies are needed to determine the efficacy of FMT for IBS-D. FUNDING/BACKGROUND:National Institutes of Health.
PMID: 31326345
ISSN: 2468-1253
CID: 3987822


Khaykis, Inessa; Ahwal, Kimberly; Sharma, Rupa; Sherman, Alex
ISSN: 0016-5107
CID: 3226922

Clinical characteristics of Asian Americans infected with hepatitis B diagnosed by community-based screenings in New York City [Meeting Abstract]

Pollack, H; Sherman, A; Tsang, T; Wan, K; Lupatkin, H; Villaneuva, G; Tso, A; Angela, T; Michael, P; Pearl, K; Ruchel, R; Rey, M; Tobias, H
ISSN: 0270-9139
CID: 70934

An epidemiologic study of hepatitis B virus infection among Asian Americans in New York City [Meeting Abstract]

Wan, K; Chen, Y; Tsang, T; Sherman, A; Tso, A; Korenblit, P; Son, S; Poon, E; Ramos, R; Tobias, H; Rey, M; Pollack, H
ISSN: 0002-9262
CID: 68859

Mass screenings in New York City reveal extraordinarily high prevalence of hepatitis B in an urban Asian population [Meeting Abstract]

Sherman, A; Tsang, T; Villaneuva, G; Pollack, H; Tobias, H
ISSN: 0270-9139
CID: 59260

Endoscopy plays an important preoperative role in bariatric surgery

Sharaf, Ravi N; Weinshel, Elizabeth H; Bini, Edmund J; Rosenberg, Jonathan; Sherman, Alex; Ren, Christine J
BACKGROUND: The role of upper endoscopy (EGD) in obese patients prior to bariatric surgery is controversial. The aim of this study was to evaluate the diagnostic yield and cost of routine EGD before bariatric surgery. METHODS: The medical records of consecutive obese patients who underwent EGD prior to bariatric surgery between May 2000 and September 2002 were reviewed. Two experienced endoscopists reviewed all EGD reports, and findings were divided into 4 groups based on predetermined criteria: group 0 (normal study), group 1 (abnormal findings that neither changed the surgical approach nor postponed surgery), group 2 (abnormal findings that changed the surgical approach or postponed surgery), and group 3 (results that were an absolute contraindication to surgery). Clinically important findings included lesions in groups 2 and 3. The cost of EGD (430.72 US dollars) was estimated using the endoscopist fee under Medicare reimbursement. RESULTS: During the 28-month study period, 195 patients were evaluated by EGD prior to bariatric surgery. One or more lesions were identified in 89.7% of patients, with 61.5% having a clinically important finding. The prevalence of endoscopic findings using the classification system above was as follows: group 0 (10.3%), group 1 (28.2%), group 2 (61.5%), and group 3 (0.0%). Overall, the most common lesions identified were hiatal hernia (40.0%), gastritis (28.7%), esophagitis (9.2%), gastric ulcer (3.6%), Barrett's esophagus (3.1%), and esophageal ulcer (3.1%). The cost of performing routine endoscopy on all patients prior to bariatric surgery was 699.92 US dollars per clinically important lesion detected. CONCLUSIONS: Routine upper endoscopy before bariatric surgery has a high diagnostic yield and has a low cost per clinically important lesion detected
PMID: 15603653
ISSN: 0960-8923
CID: 49346

Fractured colon: an endoscopically distinctive lesion associated with colonic perforation following colonoscopy in patients with collagenous colitis [Case Report]

Sherman, Alex; Ackert, John J; Rajapaksa, Roshini; West, A Brian; Oweity, Thaira
BACKGROUND: Collagenous colitis is characterized by collagen deposition in the superficial colonic mucosa, beneath the surface epithelium, resulting in chronic nonbloody diarrhea of variable severity. The mucosa generally appears endoscopically normal. METHODS: We report the occurrence of distinctive linear mucosal tears, unassociated with trauma, in 4 patients during diagnostic colonoscopy. The patients' tissue specimens were examined histologically, and clinical courses were recorded. OBSERVATIONS: Recognition of linear 'fractures' was followed in 3 patients by colonic perforation. One patient required colectomy. Severe collagenous colitis was present in all. The resection specimen contained shallow linear ulcers overlying fibrotic submucosa, with pneumatosis and acute peritonitis. CONCLUSIONS: We theorize that the stiffness of the colon in areas of collagenous colitis with submucosal fibrosis makes it susceptible to linear 'fractures' during colonoscopic air insufflation with subsequent transmural air dissection. We urge extreme caution if this lesion is recognized at colonoscopy and recommend aborting the examination and obtaining plain radiographs to detect free intraperitoneal air
PMID: 15087693
ISSN: 0192-0790
CID: 56129

Hepatobiliary tuberculosis

Chapter by: Tobais H; Sherman A
in: Tuberculosis by Ron WN; Garay SM [Eds]
Philadelphia : Lippincott Williams & Wilkins, 2004
pp. 537-547
ISBN: 0781736781
CID: 3976

Endoscopy plays an important role in determining bariatric surgical approach [Meeting Abstract]

Sharaf, RN; Weinshel, EH; Bini, EJ; Rosenberg, J; Sherman, A; Ren, CJ
ISSN: 0016-5107
CID: 108241