Probiotics in Adolescent Prediabetes: A Pilot RCT on Glycemic Control and Intestinal Bacteriome

Abstract

Dysbiosis of intestinal ecology could be implicated in prediabetes. The aim of this pilot randomized controlled trial (RCT) was to collect preliminary data on the effects of probiotic supplementation (Vivomixx©) on markers of glucose metabolism, intestinal microbiome composition, and intestinal health indices, of prediabetic adolescents. The intervention group was administered probiotic sachets twice daily for 4 months, while both intervention and control groups received weekly consultation sessions for a healthier lifestyle. Thirty-two participants were recruited (1.3 participants per month) and were randomized (16 in control and 16 in intervention group). Fifteen of them signed the inform consent and never entered the study (6 in control and 9 in intervention group). Thus, seventeen participants completed the study (10 in control and 7 in intervention group), with no serious adverse events. After the 4-month intervention, no difference was observed in the markers of glycemic control between the two groups, although a minor effect was observed for fasting glucose at 1-month, probably due to the initial higher adherence to the probiotic supplements. Modifications of the protocol procedures are warranted because of the high attrition rates and suboptimal compliance that were noted. Future studies and further RCTs with larger samples need to be conducted to fully elucidate the potential effects of probiotics in the glycemic control of prediabetic adolescents.