The double-blind, randomised and placebo controlled study, which was published in the Journal of Pediatrics, was conducted by a research team from the Department of Pediatrics at the University of Naples led by Professor Annemaria Staiano.
They found that infants treated with L reuteri had a significantly higher defecation frequency than subjects receiving a placebo over eight weeks.
The authors of the study said that only 60 per cent of children with constipation have successful treatment with laxatives, and a sizable proportion of children need long-term therapy. Moreover, approximately 30 per cent of children beyond puberty continue to struggle with constipation symptoms.
Development of new therapeutic strategies is necessary to treat these challenging patients more effectively, argue the researchers, pointing to the growing interest in the use of probiotics in organic and functional gastrointestinal disorders on the basis of reported dysbiosis in the intestinal flora of patients with chronic constipation.
Probiotics might improve intestinal motility also, said the authors. They explained that bifidobacteria and lactobacilli produce lactic acid, acetic acid, and other acids, resulting in a lowering of pH in the colon. “A lower pH enhances peristalsis of the colon and subsequently decreases colonic transit time, which is beneficial in the treatment of constipation.”
The Swedish biotechnology company BioGaia, which supplied the probiotic product, L. reuteri Protectis for the clinical trial through its Italian distributor Noos, stressed that it did not commission the research but said that the study provides “further evidence of a positive and beneficial effect of L. reuteri Protectis on infant gut function, in this case observed as an improvement in bowel movements.”
Eamonn Connolly, senior vice president research at BioGaia, said that the new data are consistent with earlier evidence of beneficial effects of L. reuteri Protectis in infantile colic (Dr Savino, Turin) and gut motility (Dr Indrio, Bari) and “indicate the ability of this probiotic to ameliorate gastrointestinal disturbance in infants and young children.”
He told NutraIngredients.com that the data from Professor Staiano will strengthen the rationale for use of L. reuteri Protectis in infants among paediatricians and thereby increase the take-up of this probiotic product in the global market.
The researchers noted that a limited number of studies have been published about the effects of probiotics on constipation in children, and, moreover, there is little evidence in the literature to recommend the use of probiotics in children affected by chronic constipation, with this factor prompting their research.
The authors reported that a double-blind, placebo-controlled, randomized study was conducted from January 2008 to December 2008 in 44 consecutive infants at least 6 months old admitted to the Gastrointestinal Endoscopy and Motility Unit of the Department of Pediatrics at the University of Naples, with a diagnosis of functional chronic constipation.
The 44 infants with chronic constipation were randomly assigned to two groups: group A received supplementation with the probiotic L reuteri and group B received a placebo.
L reuteri was administered at a dose of 108 colony-forming units in five drops of a commercially
available oil suspension 30 minutes after feeding, once per day for 8 weeks. The authors said that the study groups were well matched in age, sex, and constipation characteristics. No differences have been identified in the diet of infants treated with L reuteri and that of the placebo group.
Primary outcome measures, they continued, were frequency of bowel movements per week, stool consistency, and presence of inconsolable crying episodes, recorded in a daily diary by parents.
The researchers found that infants receiving L reuteri had a significantly higher frequency of bowel movements than infants receiving a placebo at intervals of two, four and eight weeks of supplementation.
However, there was no significant difference between L reuteri and placebo groups in the stool consistency at all weeks, they noted. And the authors also found that there was statistically no difference in the two groups in the presence of inconsolable crying episodes. No adverse effects were reported, added the team.
The researchers concluded that the administration of L reuteri in infants with chronic constipation had a positive effect on bowel frequency, even when there was no improvement in stool consistency and episodes of inconsolable crying episodes.
The team said that further research is needed to evaluate a “possible link between constipation and changes in intestinal flora.”
Source: Journal of Pediatrics
Published online ahead of print: 10.1016/j.jpeds.2010.04.066
Title: Lactobacillus reuteri (DSM 17938) in Infants with Functional Chronic Constipation: A Double-Blind, Randomized, Placebo-Controlled Study
Authors: P Coccorullo, C Strisciuglio, M Martinelli, E Miele, L Greco, A Staiano