In an attempt to study the association between Pseudomonas aeruginosa colonization and clinical factors present before colonization, we studied 502 patients who attended our cystic fibrosis (CF) clinic between 1975 and 1988 and who were not colonized with P. aeruginosa before the study period. Twelve percent of the patients became colonized with P. aeruginosa before the age of 1 year and 44% by the age of 7 years. In a birth cohort followed from diagnosis during the study period, 23% were colonized with P. aeruginosa before age 1 year and 67% before age 7 years. Early P. aeruginosa colonization was associated with early diagnosis of CF. Presence of meconium ileus, gastrointestinal symptoms and pancreatic insufficiency at the time of diagnosis was also associated with early colonization. There was no association between the presence of respiratory symptoms at the time of diagnosis and age at first P. aeruginosa colonization. In families in which more than one sibling had CF, the age of P. aeruginosa acquisition was similar in the first colonized and the subsequently colonized siblings. In the year before the colonization patients with P. aeruginosa who were older than 1 year had higher rates of hospitalization and spent more days in hospital compared with patients without P. aeruginosa. In conclusion most P. aeruginosa colonization occurs at a younger age than previously reported. Early age at diagnosis and presence of CF-associated gastrointestinal abnormalities increase the likelihood of earlier colonization of P. aeruginosa.