title: Test-based exclusion diets in gastro-esophageal reflux disease patients: a randomized controlled pilot trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Caselli
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Zuliani
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Cassol
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Nadia
authors.initials: N
authors.lastname: Fusetti
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Zeni
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Natalina
authors.initials: N
authors.lastname: Lo Cascio
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Soavi
authors.affiliation: Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Gullini
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005512:Food Hypersensitivity / Q000150:complications / Q000175:diagnosis / Q000178:diet therapy* / Q000276:immunology; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000178:diet therapy* / Q000209:etiology / Q000276:immunology; D006801:Humans; D007962:Leukocytes / Q000276:immunology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: Exclusion diet; Food intolerance; Gastro-esophageal reflux disease; Leukocytotoxic test; Treatment