This was an open, randomised trial in 53 children with functional constipation, diagnosed according to Rome III criteria. 25 children were given L. reuteri Protectis 10^8 CFU per day (5 drops), and 28 were given lactulose, 1 ml/kg/day, i.e. a common treatment of constipation in children.
Outcome measures were:
- Frequency of weekly bowel movements
- Consistency of bowel movements
- Changes in other constipation-associated symptoms
- Quality of Life (QoL) of children
- Perception of Disease by the children
- Parents’ view on QoL of the child
- Parents’ perception of disease
Results show that L. reuteri Protectis was equivalent to lactulose in effects on functional constipation. L. reuteri Protectis and lactulose both increased the frequency of defecation and faecal consistency over four weeks. Abdominal pain and flatulence were reduced by L. reuteri Protectis compared to lactulose. Quality of life increased in both treatment groups to the level of the healthy controls.
L. reuteri Protectis was equal to lactulose in effects on bowel movements and faecal consistency in children with functional constipation.
In addition, L. reuteri Protectis:
• Reduced the incidence of abdominal pain and flatulence significantly compared to lactulose
• Restored Quality of Life scores to the level of healthy, age-matched children