Randomized Controlled Trial
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World J Gastroenterol. Dec 7, 2014; 20(45): 17190-17195
Published online Dec 7, 2014. doi: 10.3748/wjg.v20.i45.17190
Test-based exclusion diets in gastro-esophageal reflux disease patients: A randomized controlled pilot trial
Michele Caselli, Giovanni Zuliani, Francesca Cassol, Nadia Fusetti, Elena Zeni, Natalina Lo Cascio, Cecilia Soavi, Sergio Gullini
Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy
Nadia Fusetti, Sergio Gullini, Department of Gastroenterology, School of Gastroenterology, University of Ferrara, 44100 Ferrara, Italy
Elena Zeni, Natalina Lo Cascio, Center Study Association on Food Intolerance and Nutrition of Ferrara, 44100 Ferrara, Italy
Author contributions: Caselli M and Gullini S designed the research; Cassol F, Fusetti N, Zeni E and Lo Cascio N performed the research; Zuliani G and Soavi C analyzed and interpreted data and drafted the article; all authors revised the article and approved its final version.
Correspondence to: Michele Caselli, MD, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, Via Savonarola 9, 44100 Ferrara, Italy. csc@unife.it
Telephone: +39-532-239012 Fax: +39-532-210884
Received: January 6, 2014
Revised: April 29, 2014
Accepted: July 24, 2014
Published online: December 7, 2014
Abstract

AIM: To investigate the clinical response of gastro-esophageal reflux disease (GERD) symptoms to exclusion diets based on food intolerance tests.

METHODS: A double blind, randomized, controlled pilot trial was performed in 38 GERD patients partially or completely non-responders to proton pump inhibitors (PPI) treatment. Fasting blood samples from each patients were obtained; leukocytotoxic test was performed by incubating the blood with a panel of 60 food items to be tested. The reaction of leukocytes (rounding, vacuolization, lack of movement, flattening, fragmentation or disintegration of cell wall) was then evaluated by optical microscopy and rated as follows: level 0 = negative, level 1 = slightly positive, level 2 = moderately positive, and level 3 = highly positive. A “true” diet excluding food items inducing moderate-severe reactions, and a “control” diet including them was developed for each patient. Then, twenty patients received the “true” diet and 18 the “control” diet; after one month (T1) symptoms severity was scored by the GERD impact scale (GIS). Hence, patients in the “control” group were switched to the “true” diet, and symptom severity was re-assessed after three months (T2).

RESULTS: At baseline (T0) the mean GIS global score was 6.68 (range: 5-12) with no difference between “true” and control group (6.6 ± 1.19 vs 6.7 ± 1.7). All patients reacted moderately/severely to at least 1 food (range: 5-19), with a significantly greater number of food substances inducing reaction in controls compared with the “true” diet group (11.6 vs 7.0, P < 0.001). Food items more frequently involved were milk, lettuce, brewer’s yeast, pork, coffee, rice, sole asparagus, and tuna, followed by eggs, tomato, grain, shrimps, and chemical yeast. At T1 both groups displayed a reduction of GIS score (“true” group 3.3 ± 1.7, -50%, P = 0.001; control group 4.9 ± 2.8, -26.9%, P = 0.02), although the GIS score was significantly lower in “true”vs“control” group (P = 0.04). At T2, after the diet switch, the “control” group showed a further reduction in GIS score (2.7 ± 1.9, -44.9%, P = 0.01), while the “true” group did not (2.6 ± 1.8, -21.3%, P = 0.19), so that the GIS scores didn’t differ between the two groups.

CONCLUSION: Our results suggest that food intolerance may play a role in GERD symptoms development, and leucocytotoxic test-based exclusion diets may be a possible therapeutic approach when PPI are not effective or indicated.

Keywords: Gastro-esophageal reflux disease, Food intolerance, Leukocytotoxic test, Exclusion diet, Treatment

Core tip: We previously observed that gastro-esophageal reflux disease (GERD) symptoms respond to exclusion diets based on food intolerance tests. In this randomized controlled pilot trial we found that patient partially/completely non responders to proton pump inhibitors experience a significant improvement in symptoms, compared with controls, after one month of exclusion diet based on leukocytotoxic test’s results. These results indicate a possible role of food intolerance in the etiopathogenesis of GERD symptoms, and a possible therapeutic application of exclusion diets when proton pump inhibitor are not effective/indicated.