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Clinical Trial
. 2004 Oct;53(10):1459-64.
doi: 10.1136/gut.2003.037697.

Food elimination based on IgG antibodies in irritable bowel syndrome: a randomised controlled trial

Affiliations
Clinical Trial

Food elimination based on IgG antibodies in irritable bowel syndrome: a randomised controlled trial

W Atkinson et al. Gut. 2004 Oct.

Abstract

Background: Patients with irritable bowel syndrome (IBS) often feel they have some form of dietary intolerance and frequently try exclusion diets. Tests attempting to predict food sensitivity in IBS have been disappointing but none has utilised IgG antibodies.

Aims: To assess the therapeutic potential of dietary elimination based on the presence of IgG antibodies to food.

Patients: A total of 150 outpatients with IBS were randomised to receive, for three months, either a diet excluding all foods to which they had raised IgG antibodies (enzyme linked immunosorbant assay test) or a sham diet excluding the same number of foods but not those to which they had antibodies.

Methods: Primary outcome measures were change in IBS symptom severity and global rating scores. Non-colonic symptomatology, quality of life, and anxiety/depression were secondary outcomes. Intention to treat analysis was undertaken using a generalised linear model.

Results: After 12 weeks, the true diet resulted in a 10% greater reduction in symptom score than the sham diet (mean difference 39 (95% confidence intervals (CI) 5-72); p = 0.024) with this value increasing to 26% in fully compliant patients (difference 98 (95% CI 52-144); p<0.001). Global rating also significantly improved in the true diet group as a whole (p = 0.048, NNT = 9) and even more in compliant patients (p = 0.006, NNT = 2.5). All other outcomes showed trends favouring the true diet. Relaxing the diet led to a 24% greater deterioration in symptoms in those on the true diet (difference 52 (95% CI 18-88); p = 0.003).

Conclusion: Food elimination based on IgG antibodies may be effective in reducing IBS symptoms and is worthy of further biomedical research.

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Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Mean change in symptom severity scores at 12 weeks according to degree of adherence. Difference between the groups with high adherence: 101 (95% confidence interval 54, 147); ***p<0.001.
Figure 3
Figure 3
(A) Average symptom severity scores over time for the group as a whole. Difference in mean change from baseline at 12 weeks: true versus sham 39 (95% confidence interval 5, 72); *p = 0.024. (B) Average symptom severity scores over time for the full adherence group. Difference in mean change from baseline at 12 weeks: true versus sham 98 (95% confidence interval 52, 144); ***p<0.001.
Figure 4
Figure 4
(A) Mean change in the secondary outcome measures of non-colonic symptoms and quality of life for the group as a whole and the full adherence group. (B) Mean change in the secondary outcome measures of anxiety and depression for the group as a whole and the full adherence group.

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