Fan 2019.
| Methods | RCT, single centre Setting: The First Affiliated Hospital of Fujian Medical University Study duration: January 2015 to June 2016 |
| Participants | 40 with IBD randomised (19 control group, 21 observation group) UC total: 31, CD total: 9; UC control 15, CD IV 4; CD control 4, CD IV 5 Inclusion: confirmed IBD diagnosis with mild to moderate symptoms as per the current standards in China; no previous probiotic treatment; no allergy to drugs used in the present study; cognisance of the purpose of the present study and willingness to sign an informed consent Exclusion: severe heart, liver, kidney and other systemic diseases; pregnancy or lactation; unresponsive to medical treatment and with complications; immune system disorders Sex (M/F): 10/9 control group; 10/11 observation group Age (mean +/‐ SD): 39.97 +/‐ 8.68 control group; 42.56 +/‐ 7.58 observation group Site of disease: not specified Use of medication: not specified Length of time remission at study entry: not specified Number randomised: 40 Number assessed: not specified Postrandomisation exclusion: not specified Follow‐up: 40 days |
| Interventions |
IV: pentasa (mesalazine extended action tablet) as in the control regimen + probiotics (2 tablets Bifico once and three times/day + "a largely liquid‐based high nutrition diet" Control: 1 to 2 pentasa tablets once and three times/day and a maintenance dose of 1 tablet once and three times/day |
| Outcomes |
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| Notes | Mixed: contacted author for UC data This work was supported by the Fujian Province Natural Science Fund Project The authors declare that there are no conflicts of interest |