Browsing by Author "Lewis, James D."

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    Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry
    (Elsevier, 2021-01) Kelly, Colleen R.; Yen, Eugene F.; Grinspan, Ari M.; Kahn, Stacy A.; Atreja, Ashish; Lewis, James D.; Moore, Thomas A.; Rubin, David T.; Kim, Alison M.; Serra, Sonya; Nersesova, Yanina; Fredell, Lydia; Hunsicker, Dea; McDonald, Daniel; Knight, Rob; Allegretti, Jessica R.; Pekow, Joel; Absah, Imad; Hsu, Ronald; Vincent, Jennifer; Khanna, Sahil; Tangen, Lyn; Crawford, Carl V.; Mattar, Mark C.; Chen, Lea Ann; Fischer, Monika; Arsenescu, Razvan I.; Feuerstadt, Paul; Goldstein, Jonathan; Kerman, David; Ehrlich, Adam C.; Wu, Gary D.; Laine, Loren; Medicine, School of Medicine
    Background & Aims Fecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers. Methods Patients undergoing FMT in clinical practices across North America were eligible. Participating investigators enter de-identified data into an online platform, including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes. Results Of the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%). Conclusions This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT.
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    A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults with Crohn’s Disease
    (Science Direct, 2021-09-01) Lewis, James D.; Sandler, Robert; Brotherton, Carol; Brensinger, Colleen; Li, Hongzhe; Kappelman, Michael D.; Daniel, Scott G.; Bittinger, Kyle; Albenberg, Lindsey; Valentine, John F.; Hanson, John; Suskind, David; Meyer, Andrea; Compher, Charlene W.; Bewtra, Meenakshi; Saxena, Akriti; Dobes, Angela; Cohen, Benjamin; Flynn, Ann D.; Fischer, Monika; Saha, Sumona; Swaminath, Arun; Yacyshyn, Bruce; Scherl, Ellen; Horst, Sara; Curtis, Jeffrey R.; Braly, Kimberly; Nessel, Lisa; McCauley, Maureen; Herfarth, Hans; Medicine, School of Medicine
    Background & Aims This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean Diet (MD) as treatment for Crohn’s disease (CD) with mild to moderate symptoms. Methods Adult patients with CD and with mild-moderate symptoms were randomly assigned 1:1 to consume the MD or SCD for 12 weeks. For the first 6-weeks, participants received prepared meals and snacks according to their assigned diet. After 6-weeks, participants were instructed to follow the diet independently. The primary outcome was symptomatic remission at week 6. Key secondary outcomes at week 6 included: fecal calprotectin (FC) response (FC <250 μg/g and reduction by >50% among those with baseline FC >250 μg/g) and C-Reactive Protein (CRP) response (high-sensitivity CRP (hsCRP) <5 mg/L and >50% reduction from baseline among those with hsCRP >5mg/L). Results 194 patients were randomized, and 191 were included in the efficacy analyses. The percentage of participants who achieved symptomatic remission at week 6 was not superior with SCD (SCD 46.5%, MD 43.5%; P = .77). FC response was achieved in 8/23 participants (34.8%) with SCD and 4/13 participants (30.8%) with MD (P = .83). CRP response was achieved in 2/37 participants (5.4%) with SCD and 1/28 participant (3.6%) with MD (P = .68). Conclusions SCD was not superior to MD to achieve symptomatic remission, FC response and CRP response. CRP response was uncommon. Given these results, the greater ease of following the MD, and other health benefits associated with MD, the MD may be preferred to the SCD for most patients with CD with mild to moderate symptoms.
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    The Development and Initial Findings of A Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD)
    (Oxford University Press, 2022) Raffals, Laura E.; Saha, Sumona; Bewtra, Meenakshi; Norris, Cecile; Dobes, Angela; Heller, Caren; O’Charoen, Sirimon; Fehlmann, Tara; Sweeney, Sara; Weaver, Alandra; Bishu, Shrinivas; Cross, Raymond; Dassopoulos, Themistocles; Fischer, Monika; Yarur, Andres; Hudesman, David; Parakkal, Deepak; Duerr, Richard; Caldera, Freddy; Korzenik, Joshua; Pekow, Joel; Wells, Katerina; Bohm, Matthew; Perera, Lilani; Kaur, Manreet; Ciorba, Matthew; Snapper, Scott; Scoville, Elizabeth A.; Dalal, Sushila; Wong, Uni; Lewis, James D.; Medicine, School of Medicine
    Background: Clinical and molecular subcategories of inflammatory bowel disease (IBD) are needed to discover mechanisms of disease and predictors of response and disease relapse. We aimed to develop a study of a prospective adult research cohort with IBD (SPARC IBD) including longitudinal clinical and patient-reported data and biosamples. Methods: We established a cohort of adults with IBD from a geographically diverse sample of patients across the United States with standardized data and biosample collection methods and sample processing techniques. At enrollment and at time of lower endoscopy, patient-reported outcomes (PRO), clinical data, and endoscopy scoring indices are captured. Patient-reported outcomes are collected quarterly. The quality of clinical data entry after the first year of the study was assessed. Results: Through January 2020, 3029 patients were enrolled in SPARC, of whom 66.1% have Crohn's disease (CD), 32.2% have ulcerative colitis (UC), and 1.7% have IBD-unclassified. Among patients enrolled, 990 underwent colonoscopy. Remission rates were 63.9% in the CD group and 80.6% in the UC group. In the quality study of the cohort, there was 96% agreement on year of diagnosis and 97% agreement on IBD subtype. There was 91% overall agreement describing UC extent as left-sided vs extensive or pancolitis. The overall agreement for CD behavior was 83%. Conclusion: The SPARC IBD is an ongoing large prospective cohort with longitudinal standardized collection of clinical data, biosamples, and PROs representing a unique resource aimed to drive discovery of clinical and molecular markers that will meet the needs of precision medicine in IBD.