BACKGROUND: Most moderate-severe juvenile Crohn's disease (CD) patients are in a constant catabolic state resulting in poor weight gain and growth failure. Anti-inflammatory, immunomodulatory, and monoclonal antibody drugs, as well as growth hormone (GH), frequently fail to achieve sustained remission or reverse growth failure.

OBJECTIVE: To test whether an exclusion diet with nutraceutical therapy (DNT) could induce sustained clinical remission and weight gain, and if so does this enhance the ability for GH to reverse growth failure.

METHODS: An uncontrolled prospective case study was undertaken in six moderate- severe CD patients, two of whom had completed growth. All were treated with DNT. Adequate caloric and protein (>/= 3g/kg/d) intake for catch up weight was prescribed. Dairy products, certain grains and carrageenan containing foods were eliminated. Nutraceuticals, consisting of fish peptides, bovine colostrum, boswellia serrata, curcumin and a multivitamin were administered daily. Lactobacillus GG, a probiotic, was administered twice weekly. Recombinant human GH (rhGH) was administered daily.

RESULTS: Within 2 months of starting DNT all six patients went into remission, with discontinuation of all pharmacological drugs. Three patients have remained in sustained remission for 4 to 8 years. One patient with very severe CD had recurrence of CD symptoms after being in complete remission for 18 months, one patient was in remission for 3 years but symptoms recurred when she became less compliant to DNT and one recently treated patient remains in remission after 6 months. With the addition of rhGH, the 4 growing patients had good-excellent growth response

CONCLUSION: DNT engendered prolonged remission and restoration of normal weight in moderate-severe juvenile CD patients, providing conditions that enabled rhGH to stimulate growth. These findings justify larger controlled trials to evaluate the long-term benefit of compliance to DNT in both juvenile and adult CD patients.

BACKGROUND: The purpose of this clinical trial was to compare efficacy and safety of the Boswellia serrata extract H15 with mesalazine for the treatment of active Crohn's disease. PATIENTS AND METHODS: Randomised, double-blind, verum-controlled, parallel group comparison for which 102 Patients were randomised. The per protocol population included 44 patients treated with H15 and 39 patients treated with mesalazine. As primary outcome measure the change of the Crohn Disease Activity Index (CDAI) between the status of enrolment and end of therapy was chosen. H 15 was tested on non-inferiority compared to standard treatment with mesalazine. RESULTS: The CDAI between the status of enrolment and end of therapy after treatment with H15 was reduced by 90 and after therapy with mesalazine by 53 scores in the mean. In this non-inferiority-trial the test hypothesis was confirmed by the statistical analysis. The difference between both treatments could not be proven to be statistically significant in favor to H15 for the primary outcome measure. The secondary efficacy endpoints confirm the assessment of the comparison of H15 and mesalazine. The proven tolerability of H15 completes the results of the shown clinical efficacy. CONCLUSIONS: The study confirms that therapy with H15 is not inferior to mesalazine. This can be interpreted as evidence for the efficacy of H15 according to the state of art in the treatment of active Crohn's disease with Boswellia serrata extract, since the efficacy of mesalazine for this indication has been approved by the health authorities. Considering both safety and efficacy of Boswellia serrata extract H15 it appears to be superior over mesalazine in terms of a benefit-risk-evaluation.