Oral Effervescent Budesonide Does Not Improve Gut Healing in New Celiac Disease Patients

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.

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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