Jadrešin O, 2020
Croatia
To investigate the effect of L. reuteri DSM 17938 in the treatment of FAP in children aged 4-18 years.
This study was performed after interim analysis of Jadrešin 2017 in order reach the initial targeted sample size.
R, DB, PC 3 months + 1 month follow up
L. reuteri: 24 (1×108 CFU) Placebo: 22
Compared to placebo, L. reuteri significantly:
• increased days without pain
• reduced intensity of pain at 4 months
Pooled data from both studies confirmed increased days with out pain and reduced severity of pain.
Weizman Z, 2016
Israel
To assess the efficacy of L. reuteri DSM 17938 on FAP in children aged 6-15 years, with the primary out comes frequency and intensity of abdominal pain. Intensity measu red by Hicks face scoring system, ranking 0=no pain and 10=very severe pain.
R, DB, PC 4 weeks + 4 weeks of follow-up
L. reuteri: 47 (1×108 CFU) Placebo: 46
Compared to placebo:
• Frequency of pain was significantly reduced at 4 weeks with 1.9 vs. 3.6 episodes/week in the L. reuteri and placebo group, respectively.
• Intensity of pain was significantly reduced during the supp lementation: 4.3 vs. 7.2 on Hicks scale. This effect that was sustained at the follow-up at 8 weeks: 4.8 vs. 6.4.
• For other GI symptoms there was a significant reduction in the incidence of abdominal distention and bloating in the L. reuteri group.
Romano C, 2014
Italy
To study if L. reuteri DSM 17938 af fect FAP in children aged 6-16 years.
R, DB, PC 4 weeks suppl.+ 4w follow-up
L. reuteri: 30 (2×108 CFU) Placebo: 26
• Significantly reduced severity of abdominal pain during L. reuteri intake
• Reduction in pain sustained up to 4 weeks after cessation of L. reuteri
• Pain frequency decreased significantly during the 8 weeks in both groups
Rahmani P, 2020
India
To investigate the effect of L. reuteri DSM 17938 in the treatment of Re current Abdominal Pain in children 6 to 16 years.
R, DB, PC 4 weeks
L. reuteri: 65 (2×108 CFU) Placebo: 60
Compared to placebo, L. reuteri significantly:
• decreased the frequency, severity and duration of abdominal pain
• improved the pain pattern
Jadrešin O, 2017
Croatia
To investigate the effect of L. reuteri DSM 17938 in the treat ment of FAPand irritable bowel syndrome (IBS) in children aged 4-18 years.
R, DB, PC 3 months + 1 month of follow-up
L. reuteri: 26 (1×108 CFU) Placebo: 29
Results of interim analysis of the study:
• Significant increase in days free of pain in the L. reuteri group compared to placebo: 80% vs. 46% of study days.
• Both groups showed significant reduction in severity of pain compared to baseline.
• Results suggest an effect of L. reuteri also in children with IBS.
Maragkoudaki M, 2017
Greece, Slove nia, Poland
Multicenter trial to assess the effect of L. reuteri DSM 17938 in children with functional abdominal pain, mean age 9y. Primary outcome was pain frequency and intensity. Secon dary outcomes: other GI symptoms, need for drugs to relieve pain, child school and adult work absenteeism, treatment success (> 50% reduction in pain score).
R, DB, PC 4 weeks + 4 weeks follow-up
L. reuteri: 27 (2×108 CFU) Placebo: 27
Compared to baseline, L. reuteri significantly decreased child school and adult work absenteeism as well as the use of drugs to relieve pain. This was not seen in the placebo group.
Comment: The study was underpowered for detection of signi ficant differences between the two groups, due to premature closure of the study based on very slow inclusion rate.
Eftekhari K, 2015
Iran
To assess the effect of L. reu teri DSM 17938 in the treatment of functional abdominal pain (FAP) in children aged 4-16 years.
R, DB, PC 4 weeks + 4 weeks of follow-up
L. reuteri: 40 (1×108 CFU) Placebo: 40
There were no differences between the groups in pain fre quency, pain severity or ‘associated gut symptoms’ during the intervention and the follow-up periods. Within both groups, there was a significant reduction in pain frequency and seve rity from baseline to end of the intervention period. Study limitations: There is no account of type of placebo, and report of outcomes is not consistent.