PMID- 25493035 OWN - NLM STAT- MEDLINE DCOM- 20150903 LR - 20181113 IS - 2219-2840 (Electronic) IS - 1007-9327 (Print) IS - 1007-9327 (Linking) VI - 20 IP - 45 DP - 2014 Dec 7 TI - Test-based exclusion diets in gastro-esophageal reflux disease patients: a randomized controlled pilot trial. PG - 17190-5 LID - 10.3748/wjg.v20.i45.17190 [doi] AB - 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. FAU - Caselli, Michele AU - Caselli M AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. FAU - Zuliani, Giovanni AU - Zuliani G AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. FAU - Cassol, Francesca AU - Cassol F AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. FAU - Fusetti, Nadia AU - Fusetti N AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. FAU - Zeni, Elena AU - Zeni E AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. FAU - Lo Cascio, Natalina AU - Lo Cascio N AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. FAU - Soavi, Cecilia AU - Soavi C AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. FAU - Gullini, Sergio AU - Gullini S AD - Michele Caselli, Giovanni Zuliani, Francesca Cassol, Cecilia Soavi, Department of Medical Sciences, Internal Medicine Institute, University of Ferrara, 44100 Ferrara, Italy. LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - World J Gastroenterol JT - World journal of gastroenterology JID - 100883448 SB - IM MH - Adult MH - Double-Blind Method MH - Female MH - Food Hypersensitivity/complications/diagnosis/*diet therapy/immunology MH - Gastroesophageal Reflux/diagnosis/*diet therapy/etiology/immunology MH - Humans MH - Leukocytes/immunology MH - Male MH - Middle Aged MH - Pilot Projects MH - Prospective Studies MH - Risk Factors MH - Severity of Illness Index MH - Time Factors MH - Treatment Outcome PMC - PMC4258591 OTO - NOTNLM OT - Exclusion diet OT - Food intolerance OT - Gastro-esophageal reflux disease OT - Leukocytotoxic test OT - Treatment EDAT- 2014/12/11 06:00 MHDA- 2015/09/04 06:00 PMCR- 2014/12/07 CRDT- 2014/12/11 06:00 PHST- 2014/01/06 00:00 [received] PHST- 2014/04/29 00:00 [revised] PHST- 2014/07/24 00:00 [accepted] PHST- 2014/12/11 06:00 [entrez] PHST- 2014/12/11 06:00 [pubmed] PHST- 2015/09/04 06:00 [medline] PHST- 2014/12/07 00:00 [pmc-release] AID - 10.3748/wjg.v20.i45.17190 [doi] PST - ppublish SO - World J Gastroenterol. 2014 Dec 7;20(45):17190-5. doi: 10.3748/wjg.v20.i45.17190.