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.

The effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonates treated with phototherapy: a randomized clinical trial.

OBJECTIVES: Indirect hyperbilirubinemia during neonatal period is a common problem, and most preterm and more than half of the term neonates find this problem. Ursodeoxycholic acid (UDCA) protects the liver against oxidative stresses and prevents cellular apoptosis. In addition, it causes stimulation of bile flow, is well tolerated by the patient, and has limited side effects. Thus, the aim of this study was to investigate the effect of UDCA in treating neonates with unconjugated hyperbilirubinemia undergoing phototherapy. METHODS: In this randomized clinical trial, 220 neonates with unconjugated hyperbilirubinemia who referred to Amir-Kabir Hospital, Arak, Iran in 2017-2018, were randomly assigned to phototherapy group (Control group) and phototherapy plus UDCA group (Intervention group) as 10 mg/kg/day. The level of total bilirubin was measured at the baseline, and after 12, and 24 h using spectrophotometric, and the duration of receiving phototherapy was also measured in both groups. RESULTS: The mean age of included neonates in the control and intervention group was 5.3 and 4.9 days, respectively. The results revealed that after 12 h of treatment, the total bilirubin level in the control group had diminished by 2.70 mg/dL on average while, in the intervention group, the reduction was 3.7 md/dL (p = .001) and after 24 h of treatment, the total bilirubin level in the control group had diminished by 5.22 mg/dL on average and in the intervention group, the reduction was 6.54 md/dL (p = .001). It was also observed that there is no significant difference between groups in terms of the mean of the duration required for phototherapy (p = .63). CONCLUSIONS: UDCA combined with phototherapy enhances TSB decrease, but this effect is not relevant from a clinical point of view because it does not decrease phototherapy and hospital stay duration. Thus, this study does not support the UDCA use in the clinical practice. TRIAL REGISTRATION: IRCT, IRCT2017071515511N2. Registered 21 Aug 2017 - Retrospectively registered, https://en.irct.ir/trial/14763.

Comparison of child abuse history in patients with and without functional abdominal pain: a case-control study.

BACKGROUND: Gastrointestinal (GI) disorders are ranked first amongst medical diseases as a trigger of requests for mental health counselling. Child abuse has been regarded as one of the main causes of the development of functional abdominal pain (FAP) in children. This study aimed, therefore, to compare the prevalence of child abuse experience among two groups of patients with and without FAP. METHODS: A case-control study of children in Arak, Iran, in which experience of child abuse was compared in children with (n = 100) and without functional abdominal pain (n = 100). Three categories of child abuse - emotional abuse, physical abuse, and neglect - were assessed using the Child Abuse Questionnaire. The data were analyzed using Stata software. RESULTS: After adjusting for potential confounders, there were group differences in emotional abuse (96% vs. 81%, aOR = 5.13, 95% CI: 1.3-20.3, p = 0.017), neglect (28% vs. 8%, aOR = 4.27, 95% CI: 1.8-11.8, p = 0.001) and total child abuse score (98% vs. 84%, aOR = 8.2, 95% CI: 1.5-43.8, p = 0.014) but not in physical abuse (57% vs. 46%, aOR = 1.47, 95% CI: 0.81-2.60, p = 0.728). CONCLUSIONS: As the prevalence of child abuse is higher in patients with FAP, child abuse appears to be related to the occurrence of FAP in children. However, the results of this study cannot be generalized to Iranian society generally and further longitudinal studies are recommended.