Long-term effects of elemental and exclusion diets for Crohn's disease.

Previous studies have confirmed the therapeutic value of elemental diets in promoting remission in active Crohn's disease, but their long-term benefit has not been established. Twenty-seven patients with established Crohn's disease who attained clinical remission after four weeks of enteral feeding were followed prospectively for up to 36 months. Twenty of these were willing to be tested for specific food intolerance using a pre-defined dietary elimination protocol; the others continued on a normal unrestricted diet. Eighteen patients (67%) have since relapsed; 89% of the relapse occurred within the first 6 months. Of the 15 patients with colonic involvement, 12 (80%) relapsed by 6 months. In contrast only 3 of 11 with isolated small bowel disease experienced early relapse. Of the 14 patients who completed the process of dietary testing, 5 could not identify any trigger foods; the remaining 9 were maintained on exclusion diets, 3 of whom relapsed early. Of the 11 taking a normal diet, 9 relapsed. Disease duration, previous intestinal resection or prior steroid therapy did not affect the relapse rate. Eight patients (31%) obtained a long-term remission, mean 23 months (range 12-36 months), without any medication. Long-lasting remissions can be obtained in about one-third of patients with Crohn's disease following treatment with a defined formula diet. Colonic involvement is associated with a high early relapse rate.

Clinical tolerance to three 5-aminosalicylic acid releasing preparations in patients with inflammatory bowel disease intolerant or allergic to sulphasalazine.

The clinical tolerance to three 5-aminosalicylic acid (5-ASA) releasing preparations (mesalazine, olsalazine and balsalazide) was assessed in a consecutive series of 43 patients with inflammatory bowel disease who were intolerant to sulphasalazine. The relative contributions to the side-effects of sulphasalazine made by its two components, 5-ASA and sulphapyridine, were also assessed in these patients. Thirty-nine (91%) patients were able to tolerate at least one of the three 5-ASA preparations. Only four (9%) patients were intolerant to all preparations, having adverse reactions previously experienced with sulphasalazine and presumably related to 5-ASA rather than sulphapyridine. The clinical tolerance to mesalazine (63%), olsalazine (70%) and balsalazide (70%) was similar, and tolerance to one drug only was found in nine (18%) patients. The commonest adverse reactions associated with 5-ASA preparations were gastrointestinal. Diarrhoea was a problem in five patients during treatment with olsalazine and three each while on mesalazine and balsalazide. Allergic reactions from 5-ASA preparations were uncommon; of ten patients with rash following sulphasalazine only one developed a rash with mesalazine. The results of this study indicate that the vast majority of patients with inflammatory bowel disease can be managed with at least one of these four 5-ASA containing preparations and that the side-effects of sulphasalazine are multifactorial in aetiology, some being due to the parent molecule, and some to one of its two metabolites, 5-ASA and sulphapyridine.

A double-blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis.

BACKGROUND: Sulfasalazine is accepted therapy for active ulcerative colitis, but side-effects and intolerance are common. Balsalazide is an azo-bonded pro-drug which also releases 5-aminosalicylic acid into the colon, but uses an inert carrier molecule. AIM: To compare the safety and efficacy of sul- fasalazine, 3 g, with balsalazide, 6.75 g, in the initial daily treatment of mild to moderate ulcerative colitis. METHODS: A randomized, multicentre, double-blind, parallel group study was performed, with a treatment duration of 8 weeks. Patients on previous maintenance treatment were excluded. The trial medication was the sole treatment for the colitis. Efficacy was assessed by patient diaries, symptom assessment, sigmoidoscopic appearance and histology. RESULTS: Fifty patients were recruited: 26 allocated to the balsalazide group and 24 to the sulfasalazine group. More patients withdrew due to adverse events in the sulfasalazine group (nine patients vs. one patient in the balsalazide group, P=0.004). Improvement occurred in both groups, with a tendency to a faster response with balsalazide. Of the patients taking balsalazide, 61% achieved clinical and sigmoidoscopic remission. CONCLUSIONS: Balsalazide, 6.75 g, is effective as the sole treatment for patients with mild to moderately active ulcerative colitis, with significantly fewer withdrawals due to side-effects than in a similar group of patients taking sulfasalazine, 3 g.

Improved maintenance of remission in ulcerative colitis by balsalazide 4 g/day compared with 2 g/day.

The efficacy of two doses of balsalazide for the maintenance of remission in patients with ulcerative colitis was compared in a double-blind multicentre trial. Sixty-five patients received a 2 g daily dose, and 68 a 4 g dose. The patient groups were similar at entry for sex, age, and disease distribution. Clinical assessment was carried out at 3-monthly intervals, with sigmoidoscopy, rectal biopsy, and blood tests on entry and at 26 and 52 weeks. Clinical relapse over twelve months was significantly less common on the 4 g dose (36%), than on the 2 g dose (55%), P less than 0.01. There were eight withdrawals on 2 g daily and 13 on 4 g daily, six and nine respectively being mainly due to gastrointestinal intolerance. It is concluded that balsalazide is a well-tolerated drug, and is effective for the maintenance of remission in patients with ulcerative colitis, the optimal dose being greater than 2 g daily.

The assessment of faecal flora in patients with inflammatory bowel disease by a simplified bacteriological technique.

A semi-quantitative bacteriological method was used to study faecal flora in 42 patients with Crohn's disease, 37 with ulcerative colitis and 21 healthy controls. Faecal homogenates were plated on primary isolation plates by a technique that allowed the growth of various microbial isolates to be assessed on a visual 1(+)-5+ score. This method was first calibrated against a standard quantitative bacteriological technique, which confirmed the reliability and reproducibility of the results obtained by the simpler method. Patients with clinically active Crohn's disease (22) had significantly higher total aerobe scores than patients with quiescent disease (20) (p less than or equal to 0.006) or ulcerative colitis (p less than or equal to 0.04) or normal controls (p less than or equal to 0.02). The scores of Escherichia coli were parallel to those of total aerobes. Lactobacillus and bifidobacteria scores were significantly reduced in patients with Crohn's disease compared to those with ulcerative colitis and controls. The anaerobic flora in both Crohn's disease and ulcerative colitis was indistinguishable from that of controls. Bacteroides vulgatus and B. fragilis were the predominant bacteroides in all groups. Patients with ulcerative colitis, regardless of disease activity, harboured faecal flora that did not differ from that of normal controls. The abnormal faecal flora in Crohn's disease did not correlate with established clinical and laboratory indicators of disease activity.

Open-access versus hospital-initiated flexible sigmoidoscopy: a comparative audit of efficacy.

BACKGROUND AND AIMS: There is a continuing demand for the provision of open-access endoscopy services. While open-access gastroscopy is now a well-established practice in most hospitals, open-access flexible sigmoidoscopy (OAS) is not yet available to the same extent. We present our early experience with OAS, a new service provided by our unit. PATIENTS, METHODS AND RESULTS: Over a 12-month period, 255 flexible sigmoidoscopies were carried out (139 OAS and 116 hospital-initiated sigmoidoscopies, HIS). Referral criteria for sigmoidoscopy were similar in both groups, with rectal bleeding and change in bowel habit being the most frequent. RESULTS: The two groups were comparable with regards to age and gender, but patients referred for OAS had symptoms for shorter duration than those referred for HIS (30 +/- 5.6 months v. 101 +/- 28 months, P < 0.00001). The diagnostic yield for OAS was 44% and for HIS 29% (P= 0.01). Significant pathology (colorectal cancer, polyps and newly diagnosed inflammatory bowel disease, colonic strictures) was detected in 31 patients (22%) in the OAS group and 12 patients (10%) in the HIS group (P = 0.02). Six cancers were diagnosed (5 OAS, 1 HIS), all staged Duke A. The waiting times for OAS and HIS were 3.1 +/- 0.3 weeks and 11.4 +/- 1.2 weeks, respectively (P = 0.0001). The diagnostic yield of fibre-optic endoscopy was independent of duration of symptoms, although patients referred for OAS with rectal bleeding and/or diarrhoea had a higher diagnostic yield (55/125, 44%). CONCLUSION: OAS is feasible and effective, with a high diagnostic yield. Such service can usually be provided with minimal added resources.

Value of technetium-99m HMPAO-labelled leucocyte scintigraphy as an initial screening test in patients suspected of having inflammatory bowel disease.

OBJECTIVE: This study was designed to evaluate the role of technetium-99m (99mTc) hexamethyl propylene amine oxime (HMPAO)-labelled leucocyte imaging as an initial screening test in patients suspected of having inflammatory bowel disease (IBD). PATIENTS AND METHODS: Thirty-one patients in whom a final diagnosis of irritable bowel syndrome (IBS) was made (group 1) and another 33 patients with established Crohn's disease (group 2) were studied. All patients had 99mTc HMPAO-labelled leucocyte scan with imaging at 40 and 120 min. Scans with abnormal bowel uptake were considered positive and this uptake was quantified by visual grading and computer-based methods (scan score). Group 1 patients with positive 99mTc HMPAO scan underwent an indium-111 (111In)-labelled leucocyte scan (imaging at 180 min) followed by endoscopy and barium radiology as deemed necessary in order to verify the 99m Tc HMPAO result. RESULTS: Three scan patterns were seen: well localized and unequivocally positive scans at both 40 min and 2 h were obtained from 28 patients. All but one had established Crohn's disease. Diffuse bowel uptake was seen in 14 scans. Ten of these (false positive) were obtained from symptomatic patients with IBS and four (false negative) from patients with asymptomatic Crohn's disease. No bowel uptake at 40 min and 2 h was seen in 22 scans. All but two of these (who had quiescent Crohn's disease) were obtained from patients with IBS. Active Crohn's disease is associated with significantly higher scan score (mean +/- SEM, 82.1 +/- 13.6) than the false positive scans (12.5 +/- 3.1, P > or = 0.001). Patients with false positive 99mTc HMPAO scans had negative 111In scans, endoscopy and barium radiology. CONCLUSION: Bowel scanning using either 111In or 99mTc HMPAO is useful in excluding active IBD. Because of radiation dose, image quality and availability 99mTc may be preferred to 111In.

Oral nutritional supplementation is effective in the maintenance of remission in Crohn's disease.

BACKGROUND: Enteral feeding with either elemental or polymeric diets is an established primary therapy for active Crohn's disease. However, the role of supplementing normal food with elemental diet in the long-term management of Crohn's disease has hitherto not been explored. PATIENTS AND METHODS: A series of 39 consecutive patients with Crohn's disease in clinical remission were studied. Of these, 21 patients (Group 1) received oral nutritional supplementation, taken in addition to their normal diet. Their outcome (relapse rate, Crohn's disease activity index, inflammatory markers) was compared with that of 18 patients (Group 2), who were maintained on a normal unrestricted diet over an observation period of 12 months. RESULTS: A total of 17 patients (81%) tolerated the nutritional supplementation. On an intention-to-treat basis, 10 patients (48%) remained in remission for 12 months, compared to 4/18 (22%) patients in Group 2, p<0.0003. Their Crohn's disease activity index and CRP remained stable while their weight and body mass index improved during the period of nutrition therapy Seven patients in Group 1 and 14 in Group 2 relapsed at a mean of 7.4+/-0.9 and 6.2+/-0.4 months, respectively. The response to nutrition supplement was independent of age, sex, disease duration or location. Four patients (19%) were intolerant to enteral feeding. CONCLUSIONS: Nutritional supplementation is safe, well tolerated and effective in the long-term management of patients with quiescent Crohn's disease.

Background subtraction: a new approach to the assessment of disease activity in Crohn's disease using 99mTc-HMPAO-labelled leucocytes.

A computer-based technique for the quantification of abnormal bowel uptake in Crohn's disease has been developed and compared with pre-existing clinical, laboratory and scintigraphic methods of assessment. The standard technique for labelling leucocytes with 99mTc-HMPAO is applied. Images were obtained at 40, 120 and 240 min after the injection of radiolabelled leucocytes. The count in the bowel area after subtracting background activity corrected to the injected dose and image acquisition times is the 'scan score', an objective measure of disease activity. The scan score is significantly higher in patients with clinically active disease (mean 82.1 +/- SEM 13.6) than in those with quiescent disease (24.7 +/- 7.0) (p < or = 0.005). Optimum separation between active and quiescent disease is achieved with a threshold scan score of 20. The scan score was comparable in small bowel disease (73.3 +/- 16.2), large bowel (94.4 +/- 33) and disease at both locations (94.1 +/- 19.2). The scan score correlated favourably with Crohn's Disease Activity Index (rs = 52, p < or = 0.0001), Harvey & Bradshow Simple Index (rs = 0.4, p < or = 0.001), serum C-reactive protein (rs = 0.72, p < or = 0.001), serum alpha acid glycoprotein (rs 0.67, p < or = 0.001), haemoglobin (rs = 0.66, p < or = 0.001), platelet count (rs = 0.47, p < or = 0.006), albumin (rs = 0.61, p < or = 0.0001) and faecal 111Indium excretion (rs = 0.78, p < or = 0.001), but not with the ESR (rs = 0.22, p < or = 0.4).(ABSTRACT TRUNCATED AT 250 WORDS)

Helicobacter pylori eradication ameliorates symptoms and improves quality of life in patients on long-term acid suppression. A large prospective study in primary care.

Our objective was to determine prescribing patterns for H2 receptor antagonists (H2RA) in primary care and to establish the prevalence and impact of Helicobacter pylori (Hp) eradication in this population of patients. Patients on long-term (6 months or longer) H2RA were identified through a computerized database at the six primary care practices in North England. Hp status was identified by serology, and those positive received standard proton pump-based triple therapy followed by a urea breath test to confirm Hp eradication. The main outcome measures were the indications for prescribing long-term H2RA in primary care, the prevalence of patients with a positive Hp serology, and the impact of Hp eradication on the subsequent need for acid suppression, severity of dyspepsia, gastrointestinal symptom rating score (GSRS), quality of life (QOL), and overall feeling of well-being. One thousand seven (1.5%) patients were on long-term H2RA. Peptic ulcer disease (PUD) was the most common indication for prescribing (42%), followed by nonulcer dyspepsia (28%) and gastroesophageal reflux disease (23%). In 81% of the patients treatment with H2RA therapy followed a previous endoscopic or radiological investigation. Only 27 (2.5%) patients had had their Hp status checked within the last 6 months. Of the 471 patients who eventually had their Hp serology tested, 297 (63%) were Hp positive. Fifty-eight percent of the Hp-positive patients had PUD. Successful Hp eradication was achieved in 250 (84%) of the patients, of whom 247 (83%) finished the 1-year follow-up. This was associated with a significant reduction in the amount of H2RA being consumed (P < 0.00001). There was also a significant improvement in the symptom scores and the GSRS after successful Hp eradication (P < 0.00001). Overall 67% of the patients reported an improvement in the QOL and 77% noted a feeling of well-being 1 year after Hp eradication. A significant proportion of patients in primary care is still being maintained on long-term H2RA, imposing a considerable financial drain on the NHS resources. Approximately two-thirds of these patients will be Hp positive, and among them the largest group will comprise patients with PUD. Hp eradication in such patients results in a significant reduction in usage of acid suppression and an improvement in overall QOL and severity of dyspeptic symptoms.

Controlled trial of polymeric versus elemental diet in treatment of active Crohn's disease.

30 patients with active Crohn's disease, mean Crohn's Disease Activity Index 301 (SE 32), who would otherwise have been treated with steroids, were randomised to receive for 4 weeks either an elemental diet ('Vivonex') (n = 16) or a polymeric diet ('Fortison') (n = 14). Assessment on days 10 and 28 showed that clinical remission occurred in 5 (36%) of the 14 patients on fortison compared with 12 (75%) of the 16 patients assigned to vivonex. The difference in remission rate was significant (p less than 0.03). Dietary treatment resulted in little change in the nutritional state and various laboratory indices of activity over a 4 week period despite clinical improvement. Polymeric diets do not seem to offer an effective therapeutic alternative to elemental diets in patients with acute exacerbations of Crohn's disease.

Virulence properties of Escherichia coli strains isolated from patients with inflammatory bowel disease.

Escherichia coli strains cultured from 74 patients with inflammatory bowel disease at different stages of disease activity (Crohn's disease (40), ulcerative colitis (34)) and 18 healthy controls were studied in relation to haemolysin and verotoxin production and enteroadherence. Disease activity was assessed by standard clinical and laboratory tests. Haemolytic E coli were isolated from 18% of patients with Crohn's disease, 24% with ulcerative colitis, and 11% of healthy controls. None of these differences was significant. No verotoxin producing strains were detected among the 216 E coli isolates examined but the extract from five strains (Crohn's (4), ulcerative colitis (1) produced a distinctive cytopathic effort on Vero cell monolayers which was later shown not to be due to verotoxin. The adhesion indices of E coli isolates cultured were: mean (SEM) 42.2 (6.4) for Crohn's disease, 43.3 (6.2) for ulcerative colitis, and 11.3 (2.0) for normal controls (p less than or equal to 0.0001). Adhesive E coli were isolated from 62% of patients with Crohn's disease and 68% with ulcerative colitis but from only 6% of normal controls (p less than or equal to 0.0002). Neither haemolysin production nor enteroadherence was dependent upon disease activity, disease location, sulphasalazine treatment, or previous intestinal resection. These results indicate that only enteroadherent E coli were frequently associated with inflammatory bowel disease; their relation to the pathogenesis of these conditions, however, remains uncertain.

Gastroesophageal reflux before and after Helicobacter pylori eradication. A prospective study using ambulatory 24-h esophageal pH monitoring.

The aim of this study was to assess prevalence of GERD before and after Helicobacter pylori (HP) eradication utilizing 24-h esophageal pH/manometry studies. Helicobacter pylori status was confirmed by the Campylobacter like organism test. Those testing positive underwent 24-h pH/manometry followed by HP eradication therapy and urea breath test. Patients were followed up at 6 months and then at 1 year when they underwent a repeat 24-h pH/manometry. Twenty patients, 10 with non-ulcer dyspepsia (NUD) and 10 with duodenal ulcer (DU) were enrolled, though only 10 patients attended for a repeat 24-h pH/manometry study. The patients were well matched, though patients with NUD had a significantly higher symptom score at entry compared with the DU group (8.5 vs 5.7, P < 0.05). The pH and esophageal manometry data were similar in the two groups. Overall nine patients (45%; DU = 5, NUD = 4) had evidence of GERD prior to HP eradication and it persisted one year after cure of the infection. The reflux disease occurred in the presence of normal LES pressure (mean 15.6 +/- 3.3 mmHg). New onset GERD was uncommon after cure of HP infection, occurring in only one patient with NUD. Overall HP eradication had no impact on percentage of time pH < 4 (4.69 +/- 3 vs 4.79 +/- 3), episodes > 5 min (9.8 +/- 16 vs 15.5 +/- 25.3) and Johnson DeMeester Score (16.8 +/- 7.5 vs 26.8 +/- 18). In addition successful cure of HP produced no significant changes in LES pressure (17.9 +/- 3.8 mmHg vs 19.3 +/- 4.6 mmHg), and other esophageal manometry data. Half of HP-positive patients with NUD and DU have evidence of GERD before HP eradication. This persists after successful cure of the infection. New onset GERD occurs very uncommonly one year after HP eradication.

Antibodies to Saccharomyces cerevisiae in patients with Crohn's disease and their possible pathogenic importance.

Saccharomyces cerevisiae (baker's yeast) may play an important part in the pathogenesis of Crohn's disease. Because of this the levels of IgG and IgA antibodies against three S cerevisiae strains (NCYC 77, NCYC 79, and NCYC 1108) were assayed in 49 patients with Crohn's disease, 43 with ulcerative colitis, 14 with coeliac disease, and 21 healthy controls. Coded serum samples were tested by ELISA. Similar antibody patterns to all three strains were found. IgG and IgA antibody levels were significantly raised in patients with Crohn's disease compared with healthy controls (p < 0.001 and p < 0.0001 respectively) and with ulcerative colitis patients (p < 0.0001 and p < 0.0006 respectively). Raised IgA, but not IgG, yeast antibody levels were found in two patients with Crohn's disease who were intolerant to yeast, but these values were similar to those in other patients without yeast intolerance. In ulcerative colitis, both IgG and IgA levels were similar to normal controls. Patients with small bowel Crohn's disease had significantly higher IgG antibody levels than those with colonic disease (p < 0.01). High levels of IgG, but not IgA, antibody were present in patients with coeliac disease, the antibody responses being indistinguishable from those found in Crohn's disease. It is concluded that the presence of IgG antibody to S cerevisiae is characteristic but not specific to Crohn's disease. Although raised IgA antibody levels are more frequently found in Crohn's disease, their pathogenic importance remains to be established.

Does better disease-related education improve quality of life? A survey of IBD patients.

The importance of health-related quality of life (HRQOL) assessment in patients with chronic disorders such as inflammatory bowel disease (IBD) is now acknowledged by researchers. Of the many factors that may influence HRQOL, patient knowledge of the condition and disease-related information provision have hitherto not been studied. In all, 250 patients with inactive IBD (UC = 128, CD = 122) were randomly chosen from our IBD clinic. Two sets of questionnaires [initially a standard questionnaire to assess level of disease-related information by a patient information score (PIS), followed by a HRQOL questionnaire] were sent to each patient. In the PIS, a score of 7 or more indicated satisfactory disease-related knowledge and in the HRQOL, a score less than 51 suggested a normal QOL, and a score above 60 significantly impaired QOL. A total of 168 patients (66%) returned both the questionnaires (UC = 91, CD = 77). The mean QOL in patients with UC and CD was 62.2+/-8.3 and 63.9+/-9.5 respectively, (P = NS). 99 patients (59%) had significantly impaired QOL (mean score 65+/-7.6) with only 12 patients (8%), 6 in each group, having a normal QOL. Mean PIS score for the patients was 7.04+/-0.1; 53% of the UC patients and 75% of the CD patients (P = 0.006) were considered well informed (ie, PIS scores of 7 or more). The mean PIS for UC patients was 6.5+/-0.4 vs 7.5+/-0.2 for the CD group (P = 0.001). There was, however, no correlation seen between the QOL and PIS scores, both for UC and CD patients (R = 0.3). In conclusion, most patients with IBD have impaired QOL, despite of having inactive disease. The level of disease-related knowledge appears to be better in patients with CD, although that does not seem to affect QOL.

Does adjuvant nutritional support diminish steroid dependency in Crohn 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.

Controlled trial of oligopeptide versus amino acid diet in treatment of active Crohn's disease.

Elemental diets are effective in inducing remission in active Crohn's disease, but how they exert this therapeutic effect is unclear. In a previous study a whole protein containing diet proved less effective than one in which food antigens were excluded, suggesting that exclusion of food antigens from the gut was a possible mechanism. This study was designed to test whether an oligopeptide diet of hydrolysed proteins was as effective as an amino acid based diet. These diets were equally antigen free but with different nitrogen sources. Forty four patients with active Crohn's disease were randomised in a controlled trial of amino acid versus oligopeptide diet. The feeds were given by nasogastric tube in equicaloric quantities and were the sole form of nutrition. Treatment was continued for four weeks although failure to improve by day 10 resulted in withdrawal. Quantitative leucocyte scintigraphy was used to investigate the effect of diet treatment on gut inflammation. Clinical and nutritional responses to treatment were also measured. Sixteen patients entered remission (including withdrawal of corticosteroids), six patients could not tolerate the nasogastric tube, and 22 patients failed to respond. The two diets were equally effective. Patients who responded had a rapid drop in clinical index of disease activity and a major reduction in the bowel uptake of leucocytes on scintigraphy. The oligopeptide and amino acid based enteral feeds were equally effective at inducing remission in active Crohn's disease. With both diets clinical improvement was accompanied by a reduction in intestinal inflammation.

Polymeric versus elemental diet as primary treatment in active Crohn's disease: a randomized, double-blind trial.

OBJECTIVE: Enteral feeding is now an established primary therapy for active Crohn's disease. This first-double blind randomized trial was designed to compare the therapeutic efficacy of a polymeric diet (PD) with an elemental diet (ED). METHODS: Patients with active Crohn's disease (Crohn's disease activity index [CDAI] > 150, increased bowel uptake of Tc-HMPAO-labeled leukocytes, and abnormal C-reactive protein [CRP]), were randomized to receive either an ED or a PD. The two preparations were identical except for the nitrogen source, which was amino acid based in ED and intact protein in PD. Enteral feeding was considered successful if clinical remission was achieved as defined by a final CDAI of < or = 150, a reduction in the CDAI by at least 100 points from baseline level, and a normal CRP. RESULTS: Twenty-one patients were enrolled of whom 11 were randomized to PD and 10 to ED. The two groups were comparable at entry. Clinical remission was obtained in eight (80%) patients receiving ED and six (55%) patients receiving PD, p = 0.1. The treatment failed in three and two patients in the PD and ED groups, respectively. Another two patients were intolerant to the feed (PD). Reduction in the CDAI after treatment with ED (359 +/- 67 to 112 +/- 19) was similar to that seen with PD (303 +/- 27 to 97 +/- 11). Similar changes in the CRP were also observed (16 +/- 5 to 4 +/- 1.6) and (62 +/- 20 to 9 +/- 6), respectively. Overall, enteral feeding was successful in 14 patients (63%). CONCLUSIONS: Enteral nutrition is effective in treatment of active Crohn's disease. Differences in nitrogen sources of enteral feeds are not relevant to their therapeutic efficacy, as polymeric and elemental diets are equally effective.