Table 1: Pivotal clinical studies of the effects of oats on patients with celiac disease and dermatitis herpetiformis

Srinivasan et al., 1996, 1999, 2006

Micro-challenge with 500mg of gluten/day

10

2

12 wks

6 weeks

50 g/day

Yes

Self-control

Gliadin & EM Abs No detected after Oats challenge

Relapse after gluten

Normal histology after Oats challenge
No change IEL & Enterocyte height & immuno-histochemical biomarkers Lactase +

Relapse after gluten

Oats are not toxic to celiac patients

Hardman et al., 1997

10
DH patients

12 weeks

62.5 g/day
(mean)

Yes

Self-control

Gliadin Ret & EM Abs No detected after Oats challenge

Normal Histology after Oats challenge
No change IEL & Enterocyte height
No change in dermal IgA

Adults with DH tolerate moderate amounts of oats

Lundin et al., 2003

Follow up

19
18 completed the study/ 1 drop-out after 2 weeks due to GI symptoms.

12 continued oats regularly

12 weeks

1.5 y

50g/day

Less 50g/day

Yes

Self-control

Normal gliadin EM & tTG Abs

Normal Serology

18 patients with normal histology
1 villous atrophy
5+ interferon γ (IFN- γ ) mRNA

Normal histology
2+ (IFN- γ ) mRNA

Most CD patients tolerate uncontaminated oats in the diet

Reaunala et al., 1998

23 DH
11 oats
1 oats drop out due to rash

6 months

53.2 g/day (mean)

yes

11 control & self-control

8 asympomatic
2 oat & 3 control developed transient rash EM Abs normal in all subjects

Normal villous architecture, IEL & IH markers Skin biopsy no different than normal

Absence of oats toxicity in small bowel & no activation of DH

Janatuinen et al., 1995

52 in remission
26 oats/26 control
49 new Dx
19 oats/21 control
6 drop-out in oats
5 drop-out control

6 month

12 month

49.9 g/day

46.6 g/day

yes

26 in remission
21 new Dx
5 drop-out

No serology

Normal villous architecture at 6m and 12m

One out of 19 new Dx did not enter remission after 12 m/oats

Most subjects tolerated oats in the amounts of 50-70g/day in a otherwise GFD

Janatuinen et al., 2000 Continuation of study to report serology & IEL count

As above

As above

As above

Yes

As above

Gliadin Reticulin Abs no difference oats with controls

IEL no difference at 6 & 12 m/oats

Support above conclusion

Peräaho et al., 2004a

39 / 23 oats & 16 control
20 oats completed;
3 oats drop-outs due to GI symptoms

1 year

50 g/day

?

16 control

Yes
EM & tTG Abs

Biopsy available from 18 treated & 13 control; others refused it
Morphology no diff between groups
IELs higher in oats vs. Control

Oats tolerated by most, but some may have GI symptoms.
In this study is not clear if oats used were contaminated

Størsrud et al., 2003a,b

20 in remission
15 remained for 2 yr on oats
5 drop-outs

2 years

93 g/day

Yes

Self-control

Yes
Gliadin. &
EM Abs

11 patients normal at baseline & after oats
3 partial atrophy at baseline & after oats
No difference after oats baseline

Adult patients in remission can tolerate70-100 g/day of oats with nutritional & compliance benefits

Janatuinen et al., 2002 (follow-up from previous study)

35 oats/28 control
23/35 remained on oats
12 drop-outs

5 years

34 g/day (mean)

Yes, at 6-12 month, but not thereafter

28

Yes
Gliadin.
EM & Ret Abs

20/35 oats &
20/28 had biopsy
All normal
No diff oats with control group

Supports the view that oats in moderate amounts is tolerated by CD patients up to five yrs. Limitations: higher number of drop-outs; purity of oats not tested after long-term use.

Kemppainen et al., 2007 continuation of Janatuinen et al., 2002

22
12 continued on oats

10 oats drop out

5 years

As above

As above

20

Biopsy of 12 oats & 20 control IELs biomarkers
No diff oats vs. controls

Long term use of oats does not stimulate local immunologic response in the small bowel

Hoffenberg et al., 2000

10
New Dx

6 month

24 g/day

Yes

Self-control

Yes
tTG Abs

Villous architecture & IEL count improved after oats

Commercially available oats, tested for purity was tolerated by newly Dx celiac children in this study.

Högberg et al., 2004

116 New Dx
57 oats/59 control 42 oats completed the study
15 oats drop-outs

1 year

25-50 g/day

Yes

59
50 completed
7 drop-outs
2 lost to follow-up

Yes,
Gliadin & tTG Abs

Normal histology improved on oats no diff with control
Two control did not improve on GFD

Addition of oats to GFD is tolerated by newly Dx CD children

Hollén et al., 2006 continuation of Högberg et al., 2004

38
New Dx included in this part of the study

As above

As above

As above

48

Yes,
Avenin Abs

Decrease avenin Abs titers no diff with control

Oats per se do not induce humoral immune reaction

Holm et al., 2006

36/32 consented
9 new Dx
23 in remission
13/23 challenged with oats & 10/23 challenged with gluten, after relapse with gluten 9/10 placed on GDF + oats

22 long-term clinical follow-up

2 years

7 years

43 g/day
(mean)

Yes

Self-control

Yes
EM, gliadin & tTG Abs

Relapse after gluten but not oats challenge
Recovery of all groups on GFD + oats as per histology IELs & biomarkers

Pure oats can be safely added to the GFD of children with CD.
No evidence of toxicity of immune reaction.