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Objective. To evaluate the role of the endogenous protein anti-secretory factor (ASF) on the symptoms, especially loose stools, in irritable bowel ayndrome (IBS). Design. A diet with specially processed cereals (SPC) known to induce ASF production was used in patients with IBS, in an eight-week randomized, placebo-controlled study. Subjects. Eighty-two patients with IBS were randomized to a diet with either SPC or placebo. Main outcome measures. The overall clinical condition and the quality of life were measured by VAS and SF-36 questionnaire, respectively. The plasma levels of ASF were determined in 14 patients with dominating loose stools before and after diet. Results. All patients significantly (p<0.001) improved in IBS-related symptoms irrespective of active or placebo diet. In an active-diet sub-group with diarrhoea (n=11) there was a significant (p<0.05) correlation between the increase of plasma ASF level and the improvement on the VAS. Conclusion. Both study groups improved significantly on the VAS but no additive effect was seen for the active treatment. In the sub-group with loose stools, the SPC diet induced ASF plasma levels in IBS patients and was correlated to significant symptom improvement in the individual patient. [ABSTRACT FROM AUTHOR]