To study the effects of different doses of bifidobacterium tetralogy viable tablets on intestinal flora imbalance in patients with mild and moderate active ulcerative colitis.

A prospective, randomized, open and controlled study was used. Patients with ulcerative colitis with grade Ⅱ intestinal flora imbalance were selected from the Digestive Center of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from June 2018 to February 2022. They were randomly divided into group A and group B. Group A was treated with conventional dose bifidobacterium tetralogy viable tablets combined with mesalazine, and group B was treated with double dose bifidobacterium tetralogy viable tablets combined with mesalazine. The primary end point was the imbalance of intestinal flora in the two groups after 4 weeks of treatment, and the secondary end points were the relief of diarrhea symptoms, total clinical efficacy, endoscopic mucosal healing rate and adverse reactions in the two groups after 4 weeks of treatment.

A total of 66 patients were included in the study, including 22 cases of proctitis, 44 cases of left colitis, 27 cases of mild colitis and 39 cases of moderate colitis. The clinical characteristics of the two groups at baseline were basically similar. The improvement of intestinal flora imbalance: group B(25 cases of normal flora, 6 cases of grade Ⅰ flora imbalance and 2 cases of grade Ⅱ flora imbalance)was significantly better than group A(16 cases of normal flora, 12 cases of grade Ⅰ flora imbalance and 5 cases of grade Ⅱ flora imbalance, P<0.05). Secondary end points: relief of diarrhea symptoms: compared with group A, the recovery time of diarrhea symptoms in group B[(7.5±4.9)d vs.(11.8±4.8)d] and the disappearance time of mucus purulent and bloody stool(8.8±5.8)d vs.(13.3±4.7)d] were significantly shorter(P<0.05). Total clinical efficacy: group B(25 cases of clinical remission, 6 cases of clinical response and 2 cases of ineffective)was significantly better than group A(16 cases of clinical remission, 12 cases of clinical response and 5 cases of ineffective, P<0.05). Endoscopic mucosal healing rate: it was 48.6% in group A and 76.7% in group B(P<0.05). Adverse reactions: there was 1 case of upper abdominal discomfort and increased stool frequency in group A, and 1 case of heartburn and hyperactive bowel sounds in group B. No other adverse reactions were found. The liver and kidney functions of the two groups were normal.

The improvement of intestinal flora imbalance in mild and moderate active ulcerative colitis treated with double dose bifidobacterium tetralogy viable tablets for 4 weeks is better than that of conventional dose bifidobacterium tetralogy viable tablets.