Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: A protocol for randomized, double-blind, controlled trial

BACKGROUND: In recent years, the incidence of ulcerative colitis (UC) is on the rise, and most of them are young adults. As the peak of the disease overlaps with the childbearing age, it has a great impact on the fertility of female patients. We, therefore, conduct a randomized and controlled trial to evaluate the efficacy and safety of mesalazine enteric-coated tablets combined with Kangfuxin Liquid (KFX) enema for the child-bearing period female with active UC. METHODS: In this randomized controlled study, a total of 236 eligible patients will be assigned to the experimental group (n = 118) or the control group (n = 118) in a 1:1 ratio. The control group will be taken mesalazine enteric-coated tablets combined with placebo enema and the experimental group will be taken mesalazine enteric-coated tablets combined with KFX enema. Participants will receive 8 weeks of intervention treatment and 3 months of maintenance treatment before pregnancy. The primary assessment is the Mayo score. Secondary outcomes include mucosal healing, faecal calprotectin (FC), Inflammatory Bowel Disease Quality (IBDQ), and pregnancy outcome. DISCUSSION: This study will provide evidence regarding the efficacy and safety of KFX enema used before pregnancy on halting active UC, reducing the relapse rate during pregnancy, improving pregnancy outcome, and the quality of life. TRIAL REGISTRATION: Chinese Clinical Trials Register identifier, ChiCTR2000039161, registered on October 20, 2020.