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.
RCT Entities:
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 IBSpatients and was correlated to significant symptom improvement in the individual patient.