Table 1

Coeliac disease: results of clinical trials with gluten challenge, changes in mucosal histopathology, serology and symptoms

Patient, nAmount of glutenChallenge durationMean reduction in VhCRD*Mean increase in CD3+ IELsMarsh-Oberhuber classificationSerologySymptomsOther
Lähdeaho et al 201499 161.5 g6 wk0.6†NANANANA
212.0 g6 wk0.8†Statistically significant increase†NA1/21 seroconverted to positive EMATrend towards more symptomatic in GSRS, CDQ and SF-36 questionnairesαβ and γδ T cells per mm of epithelium elevated.
No change in TG2 IgA deposits.
133.0 g6 wk1.1†NANANANA
136.0 g6 wk1.7‡NANANANA
Leffler et al 201378 10+10§3 and 7.5 g§Day 30.52¶3.1 per 100 ECs¶NAMean increase in IgA-TG2 titre was 1.03¶Significant change in both CSI† and GSRS†No significant change in lactulose to mannitol ratio.
Day 141.09‡19.22 per 100 ECs¶10/20 showed histological responseMean increase in IgA-TG2 titre was 2.86†Significant change in both CSI† and GSRS†
Tack et al 013144 77 g2 wkNANA3/7 deteriorated¶1/7 seroconverted to positive IgA-TG2No significant change in CDQ5/5 had increased deposits of TG2 IgA at end.
Brottveit et al 2013 82 11Four slices of breadDay 4NAData not presented¶6/11 deterioratedNA4/11 had increased abdominal symptomsIFN-γ, IL-8 and TNF-α genes increased.†
Lähdeaho et al 201154 103–5 g12 wk1.3†39 per mm of epithelium‡NA5/10 had increase in IgA TG2 titres†8 developed mild to moderate symptoms*5/10 had increased deposits of TG2 IgA.
111–2 g12 wk1.0†20¶NA4/11 had increase in IgA TG2 titres†7 developed mild to moderate symptoms*4/11 had increased deposits of TG2 IgA.
Catassi et al 2007 145 1310 mg3 months−1%¶0%NoneNo changeNA
1350 mg−20%††+12%¶2/13 deterioratedIgA-TG2¶
IgG-AGA decreased†
Holm et al 2006 146 1014 g (range 7–19 g)3–24 monthsStatistically significant increase†Statistically significant increase†NAEMA and IgA-TG2 positive in 5/10 at 1 month4/10 developed symptoms at histological relapse
Catassi et al 1993 147 10100 mg4 wk0.2†8 per 100 ECs†NA4/10 seroconverted to positive in IgA AGANone
10500 mg0.5†15 per 100 ECs†6/8 seroconverted to positive IgA AGA3/10 showed clinical symptoms
  • *Over 0.4 is considered a statistically significant change.26

  • †Significant change compared with baseline (P≤0.05).

  • ‡Significant change compared with baseline (P<0.001).

  • §The study consisted of a low and high gluten group with no significant differences between the groups in histology or serology. In the study, the data were presented after combining the two groups.

  • ¶Non-significant change (P>0.05).

  • **Data not presented.

  • ††Significant change compared with placebo (P<0.05).

  • CDQ, Celiac Disease Questionnaire; CSI, Celiac Symptom Index; EC, epithelial cells; EMA, endomysial antibody; GSRS, Gastrointestinal Symptom Rating Scale; IFN, interferon; IL, interleukin; NA, not available; SF-36, 36-Item Short-Form ; TG2, tissue transglutaminase; TNF, tumour necrosis factor; VgCRD, villous height crypt depth ratio; wk, week.