Effect of Ensure, a defined formula diet, in patients with Crohn's disease.

A prospective controlled 6-month study was undertaken to compare the effect of Ensure, a defined formula dietary supplement, and diet counselling in 122 outpatients with Crohn's disease. The compliance to Ensure was poor due to a high incidence of side effects. Taking any amount of Ensure reduced the need for surgery and the amount of hospitalization. There was a trend for patients receiving Ensure to experience a decline in the value of their Crohn's disease activity index (p less than 0.10). No consistent effects of Ensure were seen on the amount of work missed due to Crohn's disease, in laboratory measurements, in the need for prednisone or Salazopyrin. The vitamin B12 intake was improved, but otherwise nutrient intake declined due to a decreased food intake. Thus, certain beneficial clinical trends were associated with taking Ensure, but larger numbers of compliant patients will need to be studied to better assess the long-term role of defined formula diets in the management of outpatients with Crohn's disease.