Ability of polymicrobial probiotic and mono-strain probiotic to reduce functional abdominal pain in children: a randomized clinical trial

BACKGROUND: Chronic abdominal pain is a common problem in childhood. PURPOSE: Due to the prevalence of functional abdominal pain (FAP) and the importance of probiotics, this study aimed to compare the ability of 2 probiotics to reduce and improve FAP in children. METHODS: This open-label randomized clinical trial included 116 children aged 5–15 years with FAPP who met the ROME-4 criteria and were referred to the gastrointestinal clinic of Amir-Kabir Hospital in Arak in 2020–2021. The children were randomly allocated to receive polymicrobial probiotic (PMP group) or mono-strain probiotic (MSP group) once daily for 4 weeks. The standard Wong-Baker Faces scale was used to assess symptom severity. RESULTS: Of the 116 subjects, 62 (53.5%) were boys; the mean participant age was 7.39 years (standard deviation, 3.4 years). A significant intergroup difference (P=0.003) was observed in pain severity; 10.34% of children in the PMP group had no pain, while all patients in the MSP group reported low-degree pain. There was no intergroup difference in mean pain score (P=0.466), but it decreased over time in both groups (P= 0.001). CONCLUSION: Although significantly more children were painless in the PMP versus MSP group, no significant intergroup difference in pain score was noted and symptom severity decreased in both groups. A future study with a placebo group is recommended to validate our findings.