The new Good Clinical Practice-2020 in China: Views from ethical perspective

Yang, Feng; Heng, Jianfu; Li, Kunyan; Jing, Wang

doi:10.1016/j.lanwpc.2021.100117

Cited by 3 publications

(1 citation statement)

References 5 publications

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“…Data compilation for this research occurred from January 27 to February 21, 2023. Ethical approval was secured from the ethics committee of Jiangsu Province Hospital of Chinese Medicine (Ref: No.2022NL-114-02), and the study adhered to the updated Good Clinical Practice-2020 guidelines in China ( Yang et al, 2021 ). The study was also in alignment with the Declaration of Helsinki.…”

Section: Methodsmentioning

confidence: 99%

A retrospective study investigating the clinical significance of body mass index in acute pancreatitis

Bai,

Gong,

Aierken

et al. 2024

PeerJ

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Background Acute pancreatitis is an unpredictable and potentially fatal condition for which no definitive cure is currently available. Our research focused on exploring the connection between body mass index, a frequently overlooked risk factor, and both the onset and progression of acute pancreatitis. Material/Methods A total of 247 patients with acute pancreatitis admitted to Jiangsu Provincial Hospital of Chinese Medicine from January 2021 to February 2023 were retrospectively reviewed. After screening, 117 patients with complete height and body weight data were selected for detailed assessment. Additionally, 85 individuals who underwent physical examinations at our hospital during this period were compiled to create a control group. The study received ethical approval from the ethics committee of Jiangsu Province Hospital of Chinese Medicine (Ref: No.2022NL-114-02) and was conducted in accordance with the China Good Clinical Practice in Research guidelines. Results A significant difference in body mass index (BMI) was observed between the healthy group and acute pancreatitis (AP) patients (p < 0.05), with a more pronounced disparity noted in cases of hyperlipidemic acute pancreatitis (p < 0.01). A potential risk for AP was identified at a BMI greater than 23.56 kg/m2 (AUC = 0.6086, p < 0.05). Being in the obese stage I (95%CI, [1.11–1.84]) or having a BMI below 25.4 kg/m2 (95%CI, [1.82–6.48]) are identified as risk factors for adverse AP progression. Moreover, BMI effectively predicts the onset of acute edematous pancreatitis and acute necrotizing pancreatitis (AUC = 0.7893, p < 0.001, cut-off value = 25.88 kg/m2). A higher BMI correlates with increased recurrence rates within a short timeframe (r = 0.7532, p < 0.01). Conclusions Elevated BMI is a risk factor for both the occurrence and progression of AP, and underweight status may similarly contribute to poor disease outcomes. BMI is crucial for risk prediction and stratification in AP and warrants ongoing monitoring and consideration.

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Section: Methodsmentioning

confidence: 99%

A retrospective study investigating the clinical significance of body mass index in acute pancreatitis

Bai,

Gong,

Aierken

et al. 2024

PeerJ

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Clinical trial approval in world

Peepliwal

2024

Clinical Trial Project Management

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A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Weizmannia coagulans BC99 in the treatment of chronic constipation in adults

Wu,

Bai,

Jin

et al. 2024

Front. Nutr.

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IntroductionWeizmannia coagulans has emerged as a promising candidate for the management of gastrointestinal ailments. The novel strain of Weizmannia coagulans, Weizmannia coagulans BC99 (BC99), displays robust pathogen-inhibiting capabilities, susceptibility to various antibiotics, and a high level of biosafety. Nevertheless, additional research is necessary to fully understand its effectiveness in managing chronic constipation.MethodsThis study investigates the role of BC99 in alleviating chronic constipation in a double-blind, placebo-controlled, randomized trial, and participants were divided into BC99 (2 billion CFU/d) or placebo (maltodextrin) groups for a 4-week period.Results and discussionResults showed that significant improvements were noted in the BC99 group, with an increase in complete spontaneous bowel movements (CSBM) after 4-week treatment compared to the placebo (p = 0.002). The BC99 group also showed significantly lower Quality of Life (PAC-QOL) scores and reduced Constipation Symptoms (PAC-SYM) scores after 4 weeks of treatment (p < 0.001), indicating symptomatic relief. Notably, BC99 effectively modulated key gut microbiota such as Bifidobacterium and Ruminococcus, linked to crucial metabolic pathways like glutathione metabolism. In all, BC99 is confirmed to be an effective and safe therapeutic option for the relief of adult chronic constipation, enhancing gut microbiota balance and influencing critical metabolic pathways.Clinical trial registrationChiCTR2200065493.

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The new Good Clinical Practice-2020 in China: Views from ethical perspective

Cited by 3 publications

References 5 publications

A retrospective study investigating the clinical significance of body mass index in acute pancreatitis

A retrospective study investigating the clinical significance of body mass index in acute pancreatitis

Clinical trial approval in world

A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Weizmannia coagulans BC99 in the treatment of chronic constipation in adults

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