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Clinical Trial Details

Trial ID: L2681
Source ID: NCT04982380
Associated Drug: Bifidobacterium, Lactobacillus, Enterococcus And Bacillus Cereus Tablets, Live
Title: Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus With Complication
Interventions: DRUG: Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live|DRUG: Siliankang simulating tablets
Outcome Measures: Primary: Number of bowel movements, Changes from baseline in the number of completely spontaneous bowel movements (CSBMs) and number of spontaneous bowel movements (SBMs). Effectiveness is defined as CSBMs more than 3 times weekly (including 3 times) with increase from baseline, while ineffectiveness is defined as CSBMs less than 3 times weekly or with no increase from baseline., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16|Glycosylated hemoglobin, Changes from baseline in glycosylated hemoglobin., Baseline, Week 12, Week 16|Glycosylated albumin, Changes from baseline in glycosylated albumin., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | Secondary: Gut micobiota, Changes from baseline in gut microbiota., Baseline, Week 4, Week 8, Week 12, Week 16|The ratio of CSBMs to SBMs, Changes from baseline in the ratio of CSBMs to SBMs., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16|Bristol Stool Scale, Proportions whose stool characters recover to Type III and IV by Bristol Stool Scale., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16|Bowel Function Index (BFI), Changes from baseline in the score of Bowel Function Index (BFI)., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16|Patient Assessment of Constipation symptom (PAC-SYM), Changes from baseline in the scale of Patient Assessment of Constipation symptom (PAC-SYM)., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16|Patient global impression of changes (PGIC), Difference in the Patient global impression of changes (PGIC) between experimental group and control group., Week 16|The first time of CSBM, Difference in the first time of completely spontaneous bowel movement (CSBM) between the experimental group and control group., Week 1 to Week 16|Fasting blood glucose, Changes from baseline in fasting blood glucose., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16|Serum lipid spectrum, Changes from baseline in serum lipid spectrum., Baseline, Week 12
Sponsor/Collaborators: Sponsor: Peking Union Medical College Hospital | Collaborators: First Affiliated Hospital of Harbin Medical University|The Affiliated Hospital of Inner Mongolia Medical University|Affiliated Hospital of Chengde Medical University|The First Affiliated Hospital of Zhengzhou University|Chinese Academy of Sciences|Hangzhou Grand Biologic Pharmaceutical, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-07-31
Completion Date: 2022-07-31
Results First Posted:
Last Update Posted: 2021-07-29
Locations: Peking Union Medical College Hospital, Beijing, Beijing, China
URL: https://clinicaltrials.gov/show/NCT04982380