BACKGROUND: Elemental diet is considered an effective primary treatment for active Crohn's disease, but it is usually given by a feeding tube.

METHODS: Twenty-two patients (12 males, median age 30 years, range 18-60) with moderately active Crohn's disease were enrolled in a randomized study in which the efficacy of an elemental diet administered orally was compared to high-dose corticosteroids in achieving clinical and laboratory remission. Ten patients were treated by oral elemental diet (Peptamen, Clintec, USA) and 10 received corticosteroids. Both treatment regimens lasted 2 weeks. The two groups did not differ with respect to age, sex, body weight, location of disease, treatment or disease activity prior to the study. In all patients studied, simple Crohn's disease activity index, nutritional status (expressed as body mass index), percentage of ideal body weight, fat mass, fat free mass, erythrocyte sedimentation rate, interleukin-6, intestinal permeability (expressed as permeability index), prealbumin, retinol binding protein and multiskin test were evaluated before and after treatment.

RESULTS: After 2 weeks of treatment, there were significant improvements in simple Crohn's disease activity index, erythrocyte sedimentation rate, permeability index, body mass index, prealbumin, retinol binding protein and multiskin test in the elemental diet group. There were significant improvements in simple Crohn's disease activity index and fat free mass in the corticosteroid group.

CONCLUSIONS: These data suggest that, in the short term, an oral elemental diet is at least as effective as steroids in inducing remission of mild-moderately active Crohn's disease, but it may be more effective in improving the nutritional status of these patients, probably through a more rapid restoration of normal intestinal permeability.

Elemental diets (EDs) are effective in treating Crohn's disease. We hypothesize that low dietary fat and amino acids used as the sole nitrogen source are the major contributors for the success of EDs. We examined the influences of the addition of dietary fat and protein to an ED using an indomethacin-induced inflammation model in rat small intestine. In the ED-fed rats, the intestinal damage score was decreased compared with that in the standard chow group with decreasing intestinal permeability. By supplementing an ED with soybean oil (SO), intestinal permeability was increased to a level similar to that of the standard chow group. For this group, the intestinal damage score also increased compared with that of the ED group but did not reach the levels observed in the standard chow group. The addition of dietary proteins (using heat-denatured pancreatin) resulted in intestinal damage scores that were significantly higher than those of the ED+SO-fed group. The dietary protein increased the intestinal damage score. These results suggest that EDs control inflammation by decreasing intestinal permeability and the elimination of dietary proteins.

BACKGROUND: The mechanism of action of elemental diet in Crohn's disease treatment, is unknown. Alteration of bacterial flora, low antigenicity, low fat content and improvement of nutritional status are postulated to play a role in the anti-inflammatory effect of elemental diet. AIM: To determine whether elemental diet or its modifications has a direct anti-inflammatory effect on colonic tissue biopsies in vitro.

PATIENTS AND METHODS: Colonic or ileal biopsies from 39 patients with inflammatory bowel disease and control patients were incubated for 24 hours with enteral diets in which nitrogen sources were amino acids as in elemental diet, casein or whey. Tissues were incubated with elemental diet, casein or whey, at dilutions of 1:5, 1:10 or 1:20 in Waymouth's complete medium; a medium control was also included. Tissue viability was assessed by bromodeoxyuridine uptake. Interleukin-1beta, interleukin-1 receptor antagonist and interleukin-10 concentrations in supernatants were measured by immunoassay (enzyme-linked immunosorbent assay).

RESULTS: Incubation of tissues from Crohn's disease with elemental diet resulted in an increase in the ratio of interleukin-1 receptor antagonist/interleukin-1beta vs control statistically significant at 1:10 (89.6+/-17 vs 45.7+/-9. 1, p<0.05). Incubation of Crohn's tissue with casein resulted in a significant increase of interleukin-1 receptor antagonist/interleukin-1beta ratio at dilutions 1:20, 1:10 and 1:5 (101.8+/-22.0, p=0.05, 142.8+/-24.6, p<0.05; 109.7+/-25.0, p=0.05). In ulcerative colitis tissue and non-inflamed non-inflammatory bowel disease control tissue, no significant increase in interleukin 1 receptor antagonist/interleukin-1beta ratio was seen after incubation with elemental diet, casein and whey.

CONCLUSION: Elemental diet incubation increases anti-inflammatory:proinflammatory cytokine ratio in Crohn's disease and this anti-inflammatory effect is not specifically due to amino acid composition, as diets containing casein have similar anti-inflammatory effects.

Elemental diet (ED) has been used as an enteral nutritional therapy for Crohn's disease. However, the precise mechanisms of ED remain unclear. In interleukin-10 (IL-10)-deficient cell-transferred mice, we investigated the change of intestinal microbiota with ED using molecular terminal-restriction fragment length polymorphism (T-RFLP) analysis and culture method, and evaluated its influence on therapeutic effects of ED. ED significantly suppressed intestinal inflammation. The total amount of bacteria in colitis mice fed the regular diet was higher than in normal mice but decreased in colitis mice fed ED. T-RFLP profiles of the ED group markedly differed from those of the regular diet groups. The diversity of bacterial species in the ED group decreased to 60% of that found in the regular diet groups. Among the cultivated bacteria, the change in lactic acid bacteria composition was remarkable. Lactobacillus reuteri and L. johnsonii decreased and Enterococcus faecalis and E. durans increased in the ED group. The culture supernatant of L. reuteri isolates induced significant tumor necrosis factor-alpha (TNF-alpha) and IL-6 activity in RAW 264 cells, while the culture supernatant of E. faecalis and E. durans barely induced their activity. These data suggested that reduction in amount and diversity of intestinal microbiota and decrease of proinflammatory cytokines via a change in composition of lactic acid bacteria by ED seem to contribute to reduction of bowel inflammation in this model.

Total parenteral nutrition or elemental diet can be used to induce remission of Crohn's disease. A randomized study has been conducted of 36 patients to assess the relative efficacy of the two techniques used without pharmacologic support; both were successful, and no significant differences emerged in the number of days to remission or the mean changes in Crohn's disease activity index, erythrocyte sedimentation rate, or serum albumin. The elemental diet is cheaper, simpler and safer. Uncontrolled clinical experience with 77 patients showed that personalized food exclusion diets were associated with an average annual relapse rate of only 11% for the first five years of diet alone; there have been six pregnancies and the longest remission is now 75 months. The use of elemental diet followed by the development of a personal food exclusion diet appears to be an effective long-term therapeutic strategy for Crohn's disease.

To determine whether an elemental diet or prednisolone would be more effective for treating acute Crohn's disease, a controlled trial was conducted on 20 patients with acute Crohn's disease who had never received specific treatment. The first ten patients were put on an elemental diet and the remaining ten were prescribed prednisolone for six weeks at an initial dose of 0.7 mg/kg/day. Patients were assessed using the simple activity index, body weight, erythrocyte sedimentation rate, C-reactive protein and alpha 2 globulin, serum albumin, and radiographic findings of bowel lesions. At six weeks, the patients on the elemental diet showed a significantly greater improvement in the activity index, inflammatory signs such as C-reactive protein and alpha 2 globulin, and radiographic findings of bowel lesions than did those on the steroid. Patients who were given steroids for six weeks and then treated with the elemental diet for four weeks showed improvement in the radiographic findings of bowel lesions and inflammation. The present study strongly suggests that elemental diet is superior to steroids for treating active Crohn's disease.

BACKGROUND: Nutritional therapy plays an important role in the management of Crohn disease, particularly during the acute phase. Nutritional supplementation may also prevent relapses during the quiescent phase of Crohn disease, though this aspect has not been widely explored.

METHODS: Thirty-three patients with Crohn disease in remission were studied. All had steroid-dependent disease. Patients were randomized to receive either elemental diet (n = 19, EO28 Extra) or polymeric diet (Forticips, n = 14). The supplement was given orally in addition to normal food in an amount to provide 35%-50% of pre-trial total calorie intake. Prednisolone was withdrawn gradually. Patients were followed up for 12 months. Failure was defined as increase in CDAI by 100 points from baseline to>200, inability to withdraw chronic steroid therapy completely, need for surgery or steroid therapy.

RESULTS: The nutritional supplement was successful in 14 (43%) patients who remained in remission for 12 months with complete withdrawal of steroids. The response to elemental diet (42%) was similar to that of polymeric diet (43%). Nutrition supplement failed in 13 (39%). Six (18%) patients were intolerant to enteral feeding because of smell and taste problems. Per-protocol analysis of data indicated that the success rate of nutrition supplement in steroid-dependent patients was 52% (14 out of 27 patients). No disease or patient-related factors helped predict the response to nutrition supplement.

CONCLUSION: Nutritional supplementation with either an elemental or polymeric diet may provide a safe and effective alternative to chronic steroid therapy in patients with steroid-dependent Crohn disease.

BACKGROUND & AIMS:In children, eosinophilic esophagitis (EE) is predominantly, but not exclusively, a food-hypersensitivity disorder. A crystalline amino acid-based elemental diet (ELED) formula currently remains the most effective nutritional treatment in inducing clinical and histologic remission. However, compliance with an exclusive, poor-tasting liquid formulation is difficult.

METHODS:This retrospective observational study assessed the short-term clinical and histologic responses of 2 cohorts of children with EE evaluated during 2 different time periods: one was treated with the standard 6-food elimination diet (SFED) and the other was treated with ELED. Of the 60 children who met the inclusion criteria and were compliant with the dietary protocol, 35 were treated with a diet excluding cow-milk protein, soy, wheat, egg, peanut, and seafood while allowing all other table foods and 25 were treated exclusively with ELED. Repeat esophageal biopsy specimens were obtained at least 6 weeks later.

RESULTS:Twenty-six of 35 (74%) in the SFED group and 22 of 25 (88%) in the ELED group achieved significant improvement of esophageal inflammation (

CONCLUSIONS:SFED treatment was associated with clinical and histologic improvement in EE in an observational study. It offers advantages of better acceptance, cost, and compliance than ELED and should be considered as an option in the initial management of children with EE.

OBJECTIVE: Eosinophilic esophagitis (EoE), a disorder characterized by eosinophilic infiltration of the esophageal mucosa, has been defined in large part through published case reports and series leading to ambiguity in both diagnostic and treatment options. Corticosteroids, cromolyn, and elemental diet have all been reported as successful treatments for EoE. In this study, we sought to accurately define a population of patients with EoE and then assess their response to elemental diet.

METHODS: A series of patients with chronic symptoms of gastroesophageal reflux disease and an isolated esophageal eosinophilia on esophagogastroduodenoscopy (EGD) were identified. Therapy with a proton pump inhibitor was instituted for 3 months, followed by repeat EGD when symptoms persisted. A 24-h pH probe study was performed, and those with significantly abnormal studies were excluded. The remaining patients were diagnosed with EoE and placed on an elemental diet for 1 month, followed by a repeat EGD.

RESULTS: Of 346 patients with chronic gastroesophageal reflux disease symptoms and eosinophils on esophageal biopsy, 51 (14.7%) were ultimately diagnosed with EoE. There was significant improvement in vomiting, abdominal pain, and dysphagia after the elemental diet. The median number of esophageal eosinophils per high-powered field (HPF) decreased from 33.7 before the diet to 1.0 after the diet (p<0.01). The average time to clinical improvement was 8.5 days.

CONCLUSIONS: Elemental diet resulted in striking improvement in both symptoms and histologic evidence of disease in children and adolescents with EoE, as identified by strict diagnostic criteria.

PURPOSE:There are reports that elemental diet (ED) ameliorates oral mucositis caused by antineoplastic chemotherapy. Although this effectiveness may be partly due to high nutrient absorption, the effects of chemotherapy on mucosal defense mechanisms remain unclear. We investigated the effects of oral supplementation with ED on mucin in 5-fluorouracil (5-FU)-induced intestinal mucositis.

METHODS:5-FU was administered to rats orally once daily, and ED was supplied orally twice daily for 5 days. The severity of mucositis was assessed by length, dry tissue weight, and villus height of the intestinal tract. Using anti-mucin monoclonal antibody, we compared the immunoreactivity in the gastrointestinal (GI) tract and mucin content by histological and biochemical examinations.

RESULTS:Oral supplementation with ED reduced histological damage and loss of length, dry tissue weight, and villus height induced by 5-FU administration. ED markedly altered PGM34 antibody immunoreactivity and mucin contents in the small intestine of rats with 5-FU-induced mucositis.

CONCLUSIONS:ED may possibly be more effective for the prevention of antineoplastic chemotherapy-induced mucositis through the activation of GI mucus cells.

BACKGROUND: The aim of this study was to examine the impact of elemental diet on mucosal inflammation in Crohn's disease (CD), mainly by cytokine measurements.

METHODS: Twenty-eight consecutive patients with active CD were treated with an elemental diet (Elental) for 4 weeks. The mucosal biopsies were obtained from the terminal ileum and large bowel before and after treatment. As a control group, mucosal biopsies were obtained from 20 patients without inflammation. Mucosal cytokine concentrations were measured by enzyme-linked immunosorbent assay.

RESULTS: After treatment, clinical remission was achieved in 20 patients (71%). Endoscopic healing and improvement rates were 44% and 76% in the terminal ileum and 39% and 78% in the large bowel, respectively. Histologic healing and improvement rates were 19% and 54% in the terminal ileum and 20% and 55% in the large bowel, respectively. Before treatment, the mucosal concentrations of interleukin (IL)-1beta, IL-1 receptor antagonist (IL-1ra), IL-6, IL-8, and tumor necrosis factor-alpha in the ileum and large bowel were significantly higher than in controls. These cytokine concentrations decreased to the levels of control after treatment. IL-1ra/IL-1beta ratio in the ileum and large bowel was significantly lower than in controls before treatment. The ratio increased to the level of controls after treatment. The endoscopic and histologic healing of the mucosal inflammation was associated with a decline of the mucosal cytokines and an increase of the IL-1ra/IL-1beta ratio.

CONCLUSIONS: The elemental diet (Elental) reduced mucosal cytokine production and corrected an imbalance between proinflammatory and anti-inflammatory cytokines in CD.

The persistent diarrhoea-malnutrition syndrome (PDM) remains a leading cause of morbidity and mortality in hospitals in resource-poor countries. In view of the benefits of elemental or oligomeric feeds in inflammatory bowel diseases, we performed a randomized controlled trial of an exclusive diet of amino acid-based elemental feed (AAF) compared with standard nutritional rehabilitation (based on skimmed milk and then soya) for PDM. Treatment was given for 4 weeks in the malnutrition ward of the University Teaching Hospital, Lusaka, in a single-blind study. Intestinal and systemic infections were treated with routine therapies. The main outcome measures were weight gain, recovery from diarrhoea, and mortality. Two hundred children (106 HIV seropositive, 90 HIV seronegative) were randomized; 155 children completed therapy, 39 died, and six were lost to follow-up. At randomization, they were severely malnourished: median baseline weight-for-age z-score was -4.0 (interquartile range, IQR -4.4, -3.5); 9 per cent were underweight, 23 per cent had marasmus, 47 per cent had kwashiorkor, and 21 per cent had marasmic-kwashiorkor. Weight gain was greater in the AAF group (median gain in weight-for-age z-score was 1.23, IQR 0.89-1.57) compared with the control group (0.87, IQR 0.47-1.25; p=0.002), although calorie intakes were higher in the control group. The increase in haemoglobin concentration was also greater in the AAF group (0.8 g/dl, IQR 0-1.8) than in the control group (0.3, IQR -0.6, -1.6; p=0.04). Diarrhoea frequency and global recovery scores improved equally in both treatment groups and mortality did not differ. A diet of reduced molecular complexity was associated with significantly improved weight gain.

Enteral intake of non-metabolic monosacharide and disaccharide, followed by measurement of the urinary excretion ratio of the two, is a method used to investigate intestinal permeability. L/R ratio (lactulose/1-rhamnose urinary excretion ratio) is considered an indicator of permeability of the small intestine. An increased L/R ratio is caused by mucosal disorders of the small intestine. The L/R ratio in all patients (n = 92) with Crohn's disease was 0.079 +/- 0.081 (mean +/- S.D.), which was significantly higher than the value in normal controls (0.027 +/- 0.009, n = 20, p<0.05). In 39 patients with Crohn's disease, we assessed intestinal permeability before after treatment with an elemental diet, and during remission. The L/R ratio was 0.120 +/- 0.092, before treatment and 0.065 +/- 0.097 after treatment (p<0.05), showing increased intestinal permeability before elemental dietary treatment. During remission, the L/R ratio was 0.035 +/- 0.028; this did not differ significantly from the value obtained after treatment. We conclude that intestinal permeability is useful for investigating disease activity in patients with Crohn's disease.

OBJECTIVES: This pilot study aimed to determine if an elemental diet could be used to treat patients with active rheumatoid arthritis and to compare its effect to that of oral prednisolone.

METHODS: Thirty patients with active rheumatoid arthritis were randomly allocated to 2 weeks of treatment with an elemental diet (n = 21) or oral prednisolone 15 mg/day (n = 9). Assessments of duration of early morning stiffness (EMS), pain on a 10 cm visual analog scale (VAS), the Ritchie articular index (RAI), swollen joint score, the Stanford Health Assessment Questionnaire, global patient and physician assessment, body weight, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and haemoglobin, were made at 0, 2, 4 and 6 weeks.

RESULTS: All clinical parameters improved in both groups (p<0.05) except the swollen joint score in the elemental diet group. An improvement of greater than 20% in EMS, VAS and RAI occurred in 72% of the elemental diet group and 78% of the prednisolone group. ESR, CRP and haemoglobin improved in the steroid group only (p<0.05).

CONCLUSIONS: An elemental diet for 2 weeks resulted in a clinical improvement in patients with active rheumatoid arthritis, and was as effective as a course of oral prednisolone 15 mg daily in improving subjective clinical parameters. This study supports the concept that rheumatoid arthritis may be a reaction to a food antigen(s) and that the disease process starts within the intestine.

The short- and long-term effects of an elemental diet in children with acute Crohn's disease were compared with those of prednisolone in historical controls. Clinical remission was induced in 25 of 30 and in 18 of 28 episodes treated for six weeks with an elemental diet and prednisolone. Patients with proximal disease had longer remission after treatment with an elemental diet (p<0.05) than did patients with colonic disease after treatment with prednisolone (p<0.01). Disease activity index score improved in both groups compared with the pretreatment scores (p<0.05). However, the improvement in the elemental diet group was significantly better than in the prednisolone group (p<0.001). Changes in linear growth were better after treatment with an elemental diet compared with steroids (p<0.001). Serum albumin and haematocrit concentrations all improved significantly in the children treated with an elemental diet (p<0.001) but not in those treated with steroids. Thus an elemental diet was better than prednisolone in proximal disease and confirmed improved growth and nutritional status.

Seventeen children with active Crohn's disease of the small intestine were entered into a randomised control trial comparing the efficacy of an elemental diet with that of a high dose steroid regimen. Eight children received an elemental diet (Flexical) through a nasogastric tube for six weeks, followed by reintroduction of food over six weeks during which the Flexical was stopped. Seven children were given intramuscular adrenocorticotrophic hormone followed by oral prednisolone with sulphasalazine. Two children were withdrawn from the trial. The elemental diet was equally effective in inducing an improvement in Lloyd-Still disease activity index, erythrocyte sedimentation rate, C reactive protein and albumin concentrations, and body weight as the high dose steroid regimen. Linear growth, assessed from height velocity over six months, was significantly greater in the children receiving an elemental diet.

This study examines whether treatment of acute Crohn's disease with an elemental diet improves intestinal integrity and inflammation as assessed by a 51Cr-labeled ethylenediaminetetraacetatic acid (EDTA) permeability test and the fecal excretion of 111In-labeled autologous leukocytes, respectively. Thirty-four patients with active Crohn's disease completed a 4-week treatment course with an elemental diet. Active disease was characterized by increased intestinal permeability [24-hour urine excretion of orally administered 51Cr-EDTA, 6.4% +/- 0.6% (mean +/- SE); normal, less than 3.0%] and by high fecal excretion of 111In-labeled leukocytes (14.2% +/- 1.1%; normal, less than 1.0%). Twenty-seven (80%) went into clinical remission, usually within a week of starting treatment. After 4 weeks of treatment, there was a significant decrease in both the urine excretion of 51Cr-EDTA (to 3.4% +/- 0.5%; P less than 0.01) and the fecal excretion of 111In (to 5.7% +/- 1.0%; P less than 0.001), indicating that such treatment is not just symptomatic. A framework for the mechanism by which elemental diet works, centering around the importance of the integrity of the intestinal barrier function, is proposed, and also appears to provide a logical explanation for some relapses of the disease.

BACKGROUND:Eosinophilic esophagitis (EE) is a recently described disorder identified in patients with symptoms suggestive of gastroesophageal reflux disease (GERD) but unresponsive to conventional reflux therapies. Therapies have included corticosteroids, elemental diet, and diet restriction. We report our experience with skin prick and atopy patch testing and food elimination diets in patients diagnosed as having EE.

OBJECTIVE:To identify food antigens that cause EE and the characteristics of patients who respond to food elimination vs those who are unresponsive.

METHODS:Patients diagnosed as having EE had restricted diets based on skin prick and atopy patch testing results. Additional biopsies were performed after 4 to 8 weeks of restricted diet. Demographics, atopic tendencies, and food antigens were identified retrospectively in our food allergy database.

RESULTS:A total of 146 patients diagnosed as having EE were evaluated with skin prick and atopy patch testing. Thirty-nine patients had unequivocal demonstration of food causing EE, with normalization of biopsy results on elimination and reoccurrence on reintroduction. An additional 73 patients, for a total 112 (77%) of 146 patients, had resolution of their EE as demonstrated by biopsy results. Fifteen (10%) of 146 patients were nonresponders manifested by no significant reduction in esophageal eosinophils despite restricted diet based on skin prick and atopy patch testing. Egg, milk, and soy were identified most frequently with skin prick testing, whereas corn, soy, and wheat were identified most frequently with atopy patch testing.

CONCLUSION:In more than 75% of patients with EE, both symptoms and esophageal inflammation can be significantly improved with dietary elimination of foods. Skin prick and atopy patch testing can help identify foods in most patients.