Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial.

OBJECTIVE: The impact of faecal microbiota transplantation (FMT) on microbiota engraftment in patients with metabolic syndrome is uncertain. We aimed to study whether combining FMT with lifestyle modification could enhance the engraftment of favourable microbiota in obese patients with type 2 diabetes mellitus (T2DM). DESIGN: In this double-blind, randomised, placebo-controlled trial, 61 obese subjects with T2DM were randomly assigned to three parallel groups: FMT plus lifestyle intervention (LSI), FMT alone, or sham transplantation plus LSI every 4 weeks for up to week 12. FMT solution was prepared from six healthy lean donors. Faecal metagenomic sequencing was performed at baseline, weeks 4, 16 and 24. The primary outcome was the proportion of subjects acquiring ≥20% of microbiota from lean donors at week 24. RESULTS: Proportions of subjects acquiring ≥20% of lean-associated microbiota at week 24 were 100%, 88.2% and 22% in the FMT plus LSI, FMT alone, and sham plus LSI groups, respectively (p<0.0001). Repeated FMTs significantly increased the engraftment of lean-associated microbiota (p<0.05). FMT with or without LSI increased butyrate-producing bacteria. Combining LSI and FMT led to increase in Bifidobacterium and Lactobacillus compared with FMT alone (p<0.05). FMT plus LSI group had reduced total and low-density lipoprotein cholesterol and liver stiffness at week 24 compared with baseline (p<0.05). CONCLUSION: Repeated FMTs enhance the level and duration of microbiota engraftment in obese patients with T2DM. Combining lifestyle intervention with FMT led to more favourable changes in recipients' microbiota and improvement in lipid profile and liver stiffness. TRIAL REGISTRATION NUMBER: NCT03127696.

Randomized trial examining effectiveness of lifestyle intervention in reducing gestational diabetes in high risk Chinese pregnant women in Hong Kong.

Gestational diabetes mellitus (GDM) is of public health concern. This trial examined whether a clinically proven lifestyle modification program (LMP) in early pregnancy was superior to routine antenatal care in improving GDM, maternal and infant outcomes. Chinese pregnant women at risk of GDM (n = 220) were recruited at or before 12-week gestation and randomized to either a LMP group or a routine care control group. Eighty subjects completed a dietitian-led LMP including dietary and exercise components from early pregnancy till 24-week gestation. Data were compared with those of 86 control subjects. Twenty three (26.7%) control subjects and 20 (25.0%) LMP subjects developed GDM (p = 0.798). The proportion of infants born large for gestational age and macrosomia was similar between groups. The LMP group showed a lower proportion of excessive gestational weight gain (GWG). Subgroup analysis suggested that those with higher LMP adherence showed more desirable dietary composition and energy intake, and lower proportion of excessive GWG compared with the low LMP adherence group and the control group. The potential effect of LMP on GDM and other maternal and infant outcomes, in particular GWG, as well as barriers for making lifestyle changes warrant further investigations (ClinicalTrials.gov NCT02368600).