[Infantile constipation and Allomin-lactulose. Treatment of infantile obstipation in infants fed with breast milk substitutes. A controlled clinical trial of 2 per cent and 4 per cent Allomin-lactulose].

The Authors investigated the effects of Allomin with admixture of 2% and 4% lactulose on constipation in infants aged 0-6 months reared on breast-milk substitutes. The investigation was randomized and double-blind and was carried out during the period 1.4.1987-31.7.1988 on non-hospitalized infants in the counties of Funen and North Jutland in cooperation with the health visitors in these regions. Constipation was defined as hard and difficult defaecation and the trial period lasted for 14 days. Parents of the infants who participated classified the infants' motions according to consistence and degree of difficulty in defaecation on special forms. A total of 220 children participated and these received, after randomizing, either Allomin-lactulose 2% or 4% as the only breast-milk substitute during the period of observation. The effect of treatment was defined as "no constipation" i.e. all motions during 24 hours described as easy and of normal or thin consistence. In addition, the effect was measured by the parents' general impression of what the infant thrived best on. With both of the preparations, treatment was effective in over 90% of the infants in both the groups without significant difference. The effect occurred gradually and, in some cases, up to 8-10 days after initiation of treatment without significant difference in the rate of effect between the groups. After the effect had commenced, significantly fewer thin motions occurred in the 2% group than in the 4% group. 92% of the infants in the 2% group and 91% in the 4% group wanted to continue the Allomin-lactulose preparation rather than the usual breast-milk substitute. A retrospective questionnaire to parents of 97 infants who had continued with Allomin-lactulose 2% was answered by 84.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes