An open-label randomised pilot trial on safety of wheat variety C273 in patients with adult celiac disease

Autor: Jasmine Grover, Parveen Chhuneja, Vandana Midha, Arshdeep Singh, Ramit Mahajan, Varun Mehta, Ramneek Verma, Ekta Bansal, Dipak Deka, Namita Bansal, Neena Sood, Vikram Narang, Ajit Sood
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Therapeutic Advances in Gastroenterology, Vol 13 (2020)
Druh dokumentu: article
ISSN: 1756-2848
17562848
DOI: 10.1177/1756284820944089
Popis: Background: The only effective treatment for celiac disease (CeD) is gluten free diet (GFD). However, GFD is restrictive and efforts are being made to explore alternative therapies including safer wheat varieties. Wheat variety C273 has been previously identified to have reduced load of intact T-cell stimulatory epitopes via in silico and in vitro analysis. Methods: Adult patients diagnosed with CeD and recovered on GFD were included in the study. Patients were randomised into two groups in a 2:1 ratio. Patients in group I had graded introduction of C273 wheat in diet, maintained for 24 weeks; in Group II, wheat was restricted with continuation of GFD. Clinical symptoms, serology [anti-tissue transglutaminase (anti-tTG), anti-endomysial antibody (anti-EMA)], circulating inflammatory biomarkers [intestinal fatty-acid binding protein (I-FABP), plasma citrulline, interferon-γ (IFN-γ)] and histology were evaluated periodically. Final evaluation was performed at week 28. Results: A total of 15 patients were enrolled (Group I: n = 10, Group II: n = 5). All patients except two in Group I remained compliant. None of the remaining eight patients in group I developed symptoms. No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( p > 0.05). Significant changes in plasma citrulline(29.87 ± 8.98 versus 36.58 ± 3.09, p = 0.049) and IFN-γ (44.56 ± 9.74 versus 33.50 ± 3.68; p = 0.031) were observed in Group I. Conclusion: Consumption of C273 wheat did not result in development of symptoms or evident changes in serology and histology at 28 weeks. However, variations in circulating inflammatory markers were noted. Larger randomised trials are needed to corroborate these findings. Clinical Trials Registry-India: CTRI/2018/06/014521.
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