Administrative information
Title {1} | The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial. |
Trial registration {2a and 2b}. | Chinese Clinical Trial Registry, ID: ChiCTR1800017721 (http://www.chictr.org.cn/showproj.aspx?proj=29440). Registered on 10 August 2018. All items from the World Health Organization Trial Registration Data Set could be referred in this entire protocol. |
Protocol version {3} | Protocol version No.002 / version date: Nov 22, 2019 |
Funding {4} | This research is supported by Hangzhou Grand Biologic Pharmaceutical. INC. |
Author details {5a} | Tao Bai1, Haoyu Zeng1, Yanqin Long2, Xiaoqing Li3, Xiaohong Sun3, Yu Lan4, Lingling Gao5, Lu Zhang6, Zenghui Feng6, Xiaohua Hou1, * Tao Bai and Haoyu Zeng contributed equally to this work. 1Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei China. 2Division of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. 3 East Qingchun Road, Hangzhou, Zhejiang China. 3Division of Gastroenterology, Peking Union Medical College Hospital, No.1 ShuaifuyuanWangfujingDongcheng District, Beijing China. 4Division of Gastroenterology, Beijing Jishuitan Hospital, Xicheng District Xinjiekou No. 31 East Street. 5Peking University Clinical Research Institute, No.38 Xueyuan Road Haidian District, Beijing China. 6Hangzhou Grand Biologic Pharmaceutical. INC, 63 Jiuhuan Road, Jianggan District, Hangzhou, Zhejiang Province. |
Name and contact information for the trial sponsor {5b} | XiaohuaHou Address: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei China. E-mail: houxh@hust.edu.cn |
Role of sponsor {5c} | XiaohuaHou is the principal investigator and takes responsibility for the study. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Exclusion criteria
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Withdrawal criteria
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome measures
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Type 1: Separate hard lumps, like nuts (hard to pass)
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Type 2: Sausage-shaped, but lumpy
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Type 3: Like a sausage but with cracks on its surface
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Type 4: Like a sausage or snake, smooth and soft
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Type 5: Soft blobs with clear cut edges (easy to pass)
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Type 6: Fluffy pieces with ragged edges, a mushy stool
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Type 7: Watery, no solid pieces, entirely liquid