Coccorullo P, 2010
Italy
To evaluate the effect of L. reu teri DSM 17938 in 6-12 months old infants with chronic functional constipation.
R, DB, PC 8 weeks
L. reuteri: 22 (1x108CFU) Placebo: 22
L. reuteri significantly improved:
• Defecation frequency compared to placebo
• Faecal consistency compared to baseline
Kubota M, 2020
Japan
To evaluate the efficacy of L. reuteri DSM 17938 and MgO on chronic functional constipation in children 6 months to 6 years.
R, DB, PC parallel-gro up, 4 weeks
1) L. reuteri + MgO placebo: 20
2) L. reuteri + MgO: 19
3) MgO + L. reuteri placebo: 21 (L. reuteri: 2x108CFU; MgO: 30 mg/kg bw)
All groups experienced a significant improvement in defeca tion frequency at week 4.
L. reuteri and MgO were equally effective in the manage ment of functional constipation in young children.
Contreras AAG, 2020
Mexico
To assess the efficacy of a probiotic (L. reuteri DSM 17938), a prebiotic (agave inulin) or symbiotic (both), on stool characteristics in children with cerebral palsy (CP) and chronic constipation, aged 14 to 60 months.
R, DB, PC 28 days
1) L. reuteri + agave inulin placebo: 10
2) Agave inulin + L. reuteri placebo: 10
3) L. reuteri + agave inulin: 10 4) L. reuteri placebo + agave inulin placebo: 7
(L. reuteri: 1×108 CFU; agave inulin: 4 g)
Both L. reuteri and agave inulin improved stool characteristics and constipation in children with CP. In addition, L. reuteri improved intestinal motility and lowered stool pH.
Olgaç B, 2013 Turkey
To evaluate the effects of L. reuteri DSM 17938 and lactulose, respec tively, on functional constipation in children aged 4-16 years. In addition, Quality of life (QoL) and perception of disease was asses sed at baseline and at the end of treatment by both the children and parents, and compared to QoL of a healthy group of children.
R, open 4 weeks
L. reuteri: 25 (1x108CFU) Lactulose: 28 (1mg/kg/d)
Control group of healthy children for comparison of QoL: 50
L. reuteri was equal to lactulose in significant improvement compared to baseline, in:
• Frequency of defecation
• Stool consistency
• Abdominal pain, painful defecation and stool-withholding behaviour L. reuteri was significantly more effective compa red to lactulose in reduction of:
• Abdominal pain
• Flatulence From the parents’ perspective, QoL and perception of disease was significantly improved in the lactulose group but not in the L. reuteri group. Children’s scores of QoL and perception of disease were significantly increased in both groups, and to the level of healthy children.
Zaja O, 2021
Croatia
To investigate the effect of L. reuteri DSM 17938 on constipation in child ren and adolescents with anorexia nervosa (AN).
R, DB, PC 12 weeks + 12w follow-up
L. reuteri: 15 (1×108 CFU) Placebo: 16
• At 12 weeks, stool was normalized in the majority of patients of both groups, without statistical difference.
• At follow-up, significantly more subjects in the Lr group had normalized frequency of defecation and body weight (93% and 63%, respectively, p=0.04).
• Recovery of bone health and serum vit. D levels showed a stronger positive trend in the Lr group vs. the placebo group.
Papagaroufalis K, 2014
Greece
To assess the safety of infant formula containing L. reuteri DSM 17938 during the first month of life, with special reference to D-lactic acid, in comparison to infants fed a control formula. Other outcomes were GI tolerance, sleeping and crying behaviour, growth and oc currence of adverse events.
R, DB, PC 28 days
Follow-up on days 112 and 168
L. reuteri: 36 (1×108 CFU) Control: 35
31 infants in each group took part in the follow-up on days 112 and 168
Compared to control formula:
• Regurgitation episodes were significantly fewer in the L. reuteri group
• The probiotic group had significantly lower frequency of hard stools and higher percentage of soft stools at day 28
Wegner A, 2018
Poland
Assess if functional constipation in children aged 2-7y, with prior failure of ordinary constipation treat ment, could be relieved by use of L. reuteri DSM 17938 as an adjunct to treatment with macrogole (=PEG, polyethylene glycol).
R, DB, PC
8 weeks
L. reuteri + PEG: 59 (1×108 CFU) Placebo + PEG: 62
L. reuteri had no additional effect to the treatment with mac rogole on mean number of bowel movements (BM) per week (7.5±3.3 vs 6.9±2.5, in the active and placebo group, respecti vely) or number of patients who increased their frequency of BM. The incidence of constipation-related GI symptoms was the same between groups.
Jadrešin O, 2018
Croatia
Investigate the additional effect of L. reuteri to lactulose in the treat ment of functional constipation.
R, DB, PC 12 weeks + 4 weeks follow-up
L. reuteri + lactulose: 18 Placebo + lactulose: 15 (L. reuteri: 1×108 CFU; lactulose: 1-3 ml/kg/ day)
No additional benefit of L. reuteri together with lactulose in the treatment of functional constipation. Due to slow recruitment rate the study was terminated prematurely, and therefore the results should be interpreted with caution.