A Randomized, Double-Blind Controlled Trial of Retrograde Colonic Enema Based Fecal Microbiota Transplantation in the Treatment of Childhood Constipation

Datas are from a randomized, double-blind, controlled trial of 110 children (NCT 05035784).All participants received a daily RCE followed by a 4-week FMT treatment (twice a week) and a 12-week follow-up period. Before treatment, during 4 weeks of treatment, and 12 weeks of follow-up, the spontaneous bowel movements (SBMs) ≥ 3 per week, and the RR with 95% CI were calculated as the main outcomes. Changes in the intestinal bacterial profile were analyzed by BOX-PCR-based DNA fingerprinting and sequencing at baseline and the end of the follow-up. The adverse effects were assessed based on symptoms. At the end of the follow-up period, 22 patients (40.0%) in the FMT with RCE group and 10 patients (18.2%) in the placebo with RCE group had ≥ 3 SBMs per week (Net difference 21.8%, 95%CI 13.2% to 30.4%; RR1.364, 95%CI 1.063 to 1.749; P<0.05).