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Celiac.com 01/06/2023 - Non-responsive celiac disease (NRCD) affects up to 15% of children with celiac disease. A Gluten Contamination Elimination Diet (GCED) is a more stringent diet consisting of fresh, whole, and unprocessed naturally gluten-free foods. A team of researchers recently set out to assess their approach to identifying and treating NRCD with budesonide and the Gluten Contamination Elimination Diet (GCED). Their results were encouraging. Here's what they found. The research team included Awab Ali Ibrahim, Victoria Kenyon, Alessio Fasano, and Maureen M Leonard. They are variously affiliated withthe Division of Pediatric Gastroenterology and Nutrition, MassGeneral Hospital for Children, Harvard Medical School, Boston, MA; the Department of Pediatrics, Harvard Medical School, Harvard University, Boston, MA; the Center for Celiac Research and Treatment, MassGeneral Hospital for Children, Harvard Medical School, Boston, MA; the Mucosal Immunology and Biology Research Center, MassGeneral Hospital for Children, Boston, MA; the Celiac Research Program, Harvard Medical School, Boston, MA. NRCD Defined Non-responsive celiac disease is defined as patients having persistent symptoms and enteropathy, with at least Marsh 3 histology, after following a gluten-free diet for at least 12 months. Researchers think that NRCD affects up to 15% of children with celiac disease, but there is limited data, and no research to date, describing treatment of children with this NRCD. Retrospective, Single Center Analysis The team performed a retrospective, single center analysis over a 5-year period of patients with celiac disease 18 years of age and under, who received treatment for persistent symptoms and enteropathy despite following a gluten-free diet. NRCD Patients Respond to GCED and Budesonide The team found a total of 22 patients with NRCD. Of the thirteen patients treated with the GCED for 3 months, nearly half experienced both histological and symptomatic resolution of celiac disease. Of the nine patients were treated with budesonide (6-9 mg), nearly ninety percent experienced both symptomatic and histologic resolution after treatment averaging three months. Further, more than two-thirds of patients who responded to the GCED, and 100% of patients who responded to budesonide, experienced remission of at least 6 months following treatment transition back to a gluten-free diet. Treatment of NRCD with the GCED and budesonide can provide benefit most NRCD patients. Most patients with NRCD can return to a standard gluten-free diet after about three months of treatment. This is some of the most promising treatment information we've seen with regard to NRCD. The article shows that many celiac patients not responding to a gluten-free diet can respond to a more stringent approach. The high response rate to this treatment offers exciting news for patients with NRCD and their physicians. Stay tuned for more on this and related stories. Read more at J Pediatr Gastroenterol Nutr. 2022 Nov 1;75(5):616-622.
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Hi, I was diagnosed with Celiac and removing gluten from my diet has not resulted in symptom improvement or small intestine healing. My upper endoscopy a year later shows sever villous atrophy. My GI doc in FL Cleveland Clinic referred me to a celiac and refractory celiac disease specialist in Ohio Cleveland Clinic. He feels it could be a slow healing Celiac and possibly RCD (Refractory Celiac Disease Type 1). Dr. Rubio-Tapia highly recommended Budesonide 3mg capsules three times a day and then tapering down and stopping the drug after one year. This June will be 3 years of having gastro symptoms. I must stop the inflammation and start healing. So, I am going to take Budesonide, nervously. Does anyone have Refractory Celiac Type 1? What copay assistance programs are available to help with the cost of this drug? Thanks for input and any help, Shari
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Celiac.com 05/24/2017 - Refractory celiac disease (RCD) is a rare manifestation of celiac disease that is difficult to treat, and often results in death from enteropathy-associated T-cell lymphoma. Doctors looking to treat RCD have found very limited success with a number of immunosuppressive medications (IMs), including azathioprine, systemic corticosteroids, or regular budesonide. A team of researchers at the Mayo Clinic recently set out to assess open-capsule budesonide (OB) treatment on RCD patients, including those who saw no improvement with previous IM treatments. The research team included Saurabh S Mukewar, Ayush Sharma, Alberto Rubio-Tapia, Tsung-Teh Wu, Bana Jabri and Joseph A Murray. The team first looked for RCD patients treated with OB at Mayo Clinic, Rochester, Minnesota from 2003 to 2015. They then reviewed demographic, serologic, and clinical variables in these patients. The team found a total of 57 patients who received OB as treatment for suspected RCD. Based on clonal T-cell receptor gamma gene rearrangement or aberrant phenotype of intraepithelial lymphocytes (IELs), the team classified 13 patients (23%) as having RCD-2 and 43 (75%) as RCD-1. The team was unable to determine TCR gene rearrangement status for one patient (2%). Most patients were women (69%), with an average age of 60.5 (+/- 3.5) years, while average body mass index was 28.4 kg/m2. Nearly 75% of patients suffered from diarrhea, with an average of 6 bowel movements per day (range, 4–25). Nearly half of these patients failed to improve with IM treatment. Twenty-four patients (42%) were anemic, while 12 patients (21%) had hypoalbuminemia. Biopsies showed Marsh 3 lesions in all patients, broken down as follows: 19% were Marsh 3a, 46% were Marsh 3b, and 35% were Marsh 3c. After OB therapy, 92% showed clinical improvement, while 89% showed histologic improvement. Subsequent biopsies showed that 7 out of 13 patients with RCD-2 (53%) displayed an absence of the previously observed clonal TCR gamma gene rearrangement/aberrant IEL phenotype. During the follow-up period, two patients died of enteropathy-associated T-cell lymphoma. Most RCD patients show clinical and histopathologic improvement with OB treatment, including those who previously failed to respond to other IMs. These results show that treatment with open-capsule budesonide is a promising option for patients looking to manage RCD. Source: The American Journal of Gastroenterology, (21 March 2017). doi:10.1038/ajg.2017.71
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Celiac.com 09/13/2021 - Gut damage is slow to heal in many patients with celiac disease. There has been some indication that budesonide together with a gluten-free diet can speed small bowel healing and improve symptoms improvement in patients with newly diagnosed celiac disease. A team of researchers recently set out to assess the effects of effervescent budesonide in conjunction with a gluten-free diet on Marsh grading and quantitative duodenal morphometry in newly diagnosed celiac patients. Basically, they wanted to see if the budesonide would improve the healing, compared to the gluten-free diet alone. The research team included Evan D. Newnham; Daniel Clayton-Chubb; Meena Nagarethinam; Patrick Hosking; and Peter R. Gibson. They are variously affiliated with the Departments of Pathology, Gastroenterology and Hepatology at Eastern Health in Melbourne, Victoria, Australia; Pathology, Eastern Health, Box Hill, Vic., Australia; and the Department of Gastroenterology, Alfred Health, Melbourne, Vic., Australia. The team crafted a randomized, double-blind trial that measured the effects on Marsh grading and quantitative duodenal morphometry of 10 weeks' effervescent budesonide or placebo in newly diagnosed celiac patients. They then assessed the patients' progress across numerous clinical factors at 2 months and 1 year. The study followed nineteen newly diagnosed celiac patients who randomly received budesonide, along with a control group of eighteen, who received a placebo. The team saw no differences in mucosal response (Marsh 0 or 1) between the budesonide vs placebo groups in terms of week-8 remission (Marsh 0), week-52 response, and week-52 remission. Likewise the two groups showed no difference in improvement from baseline of villous-height-to-crypt-depth ratio, nor any statistically significant differences in clinical measures or adverse events. They saw no negative effects associated with corticosteroids. Overall, they noted that Marsh 3C was present at the diagnostic biopsy in 1 of 9 achieving mucosal remission at 8 weeks compared with 18 of 23 who did not achieve it; and mean villous-height : crypt-depth ratio was 1.06 (SD: 0.73) versus 0.46 (0.38) (P = 0.005). In this study, budesonide showed no significant effect on mucosal healing in celiac patients on a gluten-free diet. Mucosal remission at 8 weeks occurred in approximately one in four patients, regardless, and was associated with less severe histological lesions at the time the patient was diagnosed. Read more in Alimentary Pharmacology & Therapeutics
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Celiac.com 04/16/2019 - A team of researchers from the Celiac Center at Beth Israel Deaconess Medical Center highlighted the potential of an enteric-release, oral budesonide as a treatment for acute reactions to gluten exposure in patients with celiac disease. The research team included Amelie Therrien, MD MSc, Jocelyn A. Silvester, MD PhD, Daniel A. Leffler, MD MSc, Ciaran P. Kelly, MD. They are variously affiliated with the Celiac Center, Department of Medicine and Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston USA; the Celiac Research Program, Harvard Medical School, Boston USA; the Division of Gastroenterology, Hepatology and Nutrition, Boston Children Hospital, Boston USA; the Rady College of Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada; and with Takeda Pharmaceutical International Co, Cambridge, USA. Celiac Center physician, Ciaran Kelly, MD, and colleagues wrote that inadvertent exposure to gluten is still common even though patients specifically try to avoid it. Researchers report on a group of consecutive celiac patients with acute gluten exposure, who were treated with enteric-related budesonide. The group included 12 patients with biopsy-confirmed celiac disease, and one patient with potential celiac disease — defined as normal duodenal histology, elevated tissue transglutaminase antibodies, HLADQ2.5 or DG8 positivity and clinical response to a gluten-free diet. Researchers measured patient-reported clinical response to budesonide, defined in terms of symptom severity and duration as “substantial,” “partial,” or, simply “response." The patients started budesonide therapy as soon as possible after gluten exposure and symptom onset. All patients reported a clinical response to the drug, with eight patients reporting "substantial" improvement of GI symptoms. The team makes clear that they do not "advocate steroid use for uncomplicated [celiac disease]." The team notes that they selected patients for the budesonide trial based on severe, debilitating gluten reactions, due to intermittent accidental gluten exposure" despite following a [gluten-free diet],” the team wrote. Though the study lacks objective endpoints and includes varying treatments, budesonide can help to relieve serious symptoms of gluten exposures in celiac patients, justifying both this, and future, clinical trials, according to Dr. Alex Young. As a disclosure, Dr. Kelley notes that he served as a scientific advisory to Cour Pharmaceuticals, Glutenostics, Innovate, ImmunogenX, and Takeda. He also acts as a principal investigator on research grants on celiac disease supported by Aptalis and Takeda. Please see the full study for all other authors’ relevant financial disclosures. Clin Gastroenterol Hepatol 2019. doi:10.1016/j.cgh.2019.03.029.
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I saw my GI yesterday. He and I agreed to start me on Entocort EC/Budesonide medication. It is a slow release 3mg capsule that is not dissolved by the stomach pH and instead gets broken down and absorbed in the intestines. It is supposed to have a local effect versus systemic and is considered safer than prednisone. I will be on 9 mg dose once a day for 2 months then we will start to taper the dose down pending my symptoms and then wean off completely. Many have good results with the course of medication and then go into 'remission' for long periods of time. I am still planning on keeping my food diary to see if I can pin point any food groups that initiate flare ups. I have a nutritionist appointment in January as well. I am hoping things will improve with the medication. I have done a lot of reading and things look optimistic!
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