Safety and Efficacy of Lactobacillus rhamnosus GG (ATCC 53103) in Children with Functional Abdominal Pain: A Randomised, Doubleblinded, Placebo-controlled Trial

Abstract

Introduction: Functional Abdominal Pain (FAP) is a major concern in developing countries, especially in school-going children. Recently, some probiotics have shown clinical evidence in managing abdominal diseases. The role of Lactobacillus rhamnosus GG (LGG) (ATCC 53103) for FAP in children has not been studied in India. Aim: To evaluate the safety and efficacy of LGG (ATCC 53103) in children with FAP in terms of frequency, severity, and adverse effects. Materials and Methods: This double-blinded, placebocontrolled study was conducted at Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India, from February 2021 to July 2022, after obtaining permission from the Institutional Ethical Committee (IEC). Children aged 5-18 years with FAP were included in the study. A total of 82 children were included in the study and were randomised into the LGG group and placebo group. The LGG group received LGG (ATCC 53103), and the placebo group received sugar powder for a period of four weeks. These patients were followed-up after 2, 4, and 8 weeks for evaluation. Student’s t-test (unpaired) was used for quantitative data, and Chi-square test was used for qualitative data. Statistical Package for the Social Sciences (SPSS) PC-20.0 version was used to evaluate the data. Results: Out of 82 children, a total of 77 children were enrolled during the study period, with 38 in the LGG group and 39 in the placebo group. The severity of abdominal pain at four weeks and eight weeks was significantly less compared to placebo (p-value=0.009 and p-value=0.01, respectively). The frequency of abdominal pain at four weeks and eight weeks was also significantly less compared to placebo (p-value ≤0.001 and p-value≤0.001, respectively). There was no statistically significant difference in adverse effects between the two groups (p-value =0.115). Conclusion: This study concluded that LGG decreases both the severity and frequency of abdominal pain in children aged 5-18 years without any significant side-effects. Thus, it can be safely used in the management of childhood FAP.