Back to resultsEfficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation
Primary Purpose
Type 2 Diabetes Mellitus With Complication
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live
Siliankang simulating tablets
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus With Complication focused on measuring Type 2 diabetes;Constipation;Gut microbiota;Bifidobacterium
Eligibility Criteria
Inclusion Criteria:
- According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically. The duration of T2DM was no more than 8 years (including 8 years).
- According to the ROME III diagnostic criteria of functional constipation or guideline for diagnosis and treatment of chronic constipation in China (2013 edition), chronic constipation was diagnosed clinically. The duration of constipation was more than 6 months (including 6 months).
- The age ranged from 18 to 70 years (including 18 and 70 years) with no restriction of sex.
- Fasting blood glucose was no more than 8mmol/L and glycosylated hemoglobin ranged from 7.0% to 10.0% (including 7.0% and 10.0%).
- Sign written consent form voluntarily.
Exclusion Criteria:
- Other types of diabetes mellitus.
- History of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome.
- Constipation induced by drugs[i.e. antidepressants, calcium antagonists, diuretics, sympathetic agents, antacids with aluminum or calcium, calcium agents, iron agents, antidiarrhetics].
- Organic constipation [i.e. intestinal diseases，endocrine and metabolic diseases (except diabetes), nervous system and muscle disease].
- Gastrointestinal diseases [i.e. colitis, mesenteric lymphadenitis, with a history of intestinal surgery].
- Using drugs that may affect clinical outcome evaluation in the past 2 weeks, such as antibiotics (penicillin, amoxicillin, erythromycin, azithromycin and cephalosporin, etc.), microecological preparations, laxative drugs (magnesium sulfate and lactulose, etc.); anthraquinones (rhubarb, aloe and senna, etc.); Gastrointestinal motility drugs (metoclopramide, domperidone, cisapride, etc).
- History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk.
- Abnormal liver function [i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value]. Abnormal renal function [Creatinine exceeds the upper limit of normal value].
- Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure < 90/50 mmHg).
- History of acute and chronic gastroenteritis or gastrointestinal surgery
- Psychosis, alcohol dependence or history of drug abuse.
- Lactating women, pregnant women and patients who have pregnancy plan during the trial or within 3 months after the trial.
- Participation in other studies three months before the trial.
- Allergic constitution or allergic to a variety of drugs.
- Those researchers think inappropriate to the research.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) 3 tablets p.o. tid for 12 weeks.
Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Siliankang simulative tablets 3 tablets p.o. tid for 12 weeks.
Outcomes
Primary Outcome Measures
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.
Glycosylated hemoglobin
Changes from baseline in glycosylated hemoglobin.
Glycosylated albumin
Changes from baseline in glycosylated albumin.
Secondary Outcome Measures
Gut micobiota
Changes from baseline in gut microbiota.
The ratio of CSBMs to SBMs
Changes from baseline in the ratio of CSBMs to SBMs.
Bristol Stool Scale
Proportions whose stool characters recover to Type III and IV by Bristol Stool Scale.
Bowel Function Index (BFI)
Changes from baseline in the score of Bowel Function Index (BFI).
Patient Assessment of Constipation symptom (PAC-SYM)
Changes from baseline in the scale of Patient Assessment of Constipation symptom (PAC-SYM).
Patient global impression of changes (PGIC)
Difference in the Patient global impression of changes (PGIC) between experimental group and control group.
The first time of CSBM
Difference in the first time of completely spontaneous bowel movement (CSBM) between the experimental group and control group.
Fasting blood glucose
Changes from baseline in fasting blood glucose.
Serum lipid spectrum
Changes from baseline in serum lipid spectrum.
Full Information
NCT ID
NCT04982380
First Posted
July 23, 2021
Last Updated
July 23, 2021
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.
1. Study Identification
Unique Protocol Identification Number
NCT04982380
Brief Title
Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation
Official Title
Efficacy and Safety of Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) in Patients With Type 2 Diabetes and Constipation: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2021 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Constipation is one of the common complication of diabetes mellitus, whose pathogenesis was previously recognized as decreased gastrointestinal motility caused by diabetic autonomic neuropathy. It is always treated with gastrointestinal motility drugs or laxatives which may have side effects such as gut microbiota dysbiosis and withdraw symptoms. Recently, researches have indicated that the risk of developing type 2 diabetes mellitus is associated with alterations in the structure of the gut microbiota and have begun to treat diabetic constipation by improving gut microbiota of these patients. The rational use of microecological preparation for the prevention and treatment of diabetic constipation has received increasing attention. This trial is aimed to evaluate the efficacy and safety of Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) in the treatment of patients with type 2 diabetes and constipation, and to analyze its influence on gut microbiota and blood glucose.
Detailed Description
This is a 16 week, 1:1 randomised, controlled, open label, two-arm, parallel-group trial evaluating efficacy and safety of Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) in patients with type 2 diabetes and constipation. Patients will be randomized into experimental group or control group treated with Siliankang or placebo tablets respectively. Total trial duration for the individual subject will be approximately 16 weeks including screening, 12-weeks treatment and 4-weeks follow-up. Patients will attend at 2-week, 8-week, 12-week and 16-week throughout the trial taking physical examination, having blood test, collecting faecal specimen and completing the questionnaire of constipation under the direction of doctors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus With Complication
Keywords
Type 2 diabetes;Constipation;Gut microbiota;Bifidobacterium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) 3 tablets p.o. tid for 12 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Siliankang simulative tablets 3 tablets p.o. tid for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live
Other Intervention Name(s)
Siliankang
Intervention Description
Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) 3 tablets p.o. tid for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Siliankang simulating tablets
Intervention Description
Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Siliankang simulative tablets 3 tablets p.o. tid for 12 weeks.
Primary Outcome Measure Information:
Title
Number of bowel movements
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Title
Glycosylated hemoglobin
Description
Changes from baseline in glycosylated hemoglobin.
Time Frame
Baseline, Week 12, Week 16
Title
Glycosylated albumin
Description
Changes from baseline in glycosylated albumin.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Secondary Outcome Measure Information:
Title
Gut micobiota
Description
Changes from baseline in gut microbiota.
Time Frame
Baseline, Week 4, Week 8, Week 12, Week 16
Title
The ratio of CSBMs to SBMs
Description
Changes from baseline in the ratio of CSBMs to SBMs.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Title
Bristol Stool Scale
Description
Proportions whose stool characters recover to Type III and IV by Bristol Stool Scale.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Title
Bowel Function Index (BFI)
Description
Changes from baseline in the score of Bowel Function Index (BFI).
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Title
Patient Assessment of Constipation symptom (PAC-SYM)
Description
Changes from baseline in the scale of Patient Assessment of Constipation symptom (PAC-SYM).
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Title
Patient global impression of changes (PGIC)
Description
Difference in the Patient global impression of changes (PGIC) between experimental group and control group.
Time Frame
Week 16
Title
The first time of CSBM
Description
Difference in the first time of completely spontaneous bowel movement (CSBM) between the experimental group and control group.
Time Frame
Week 1 to Week 16
Title
Fasting blood glucose
Description
Changes from baseline in fasting blood glucose.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Title
Serum lipid spectrum
Description
Changes from baseline in serum lipid spectrum.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically. The duration of T2DM was no more than 8 years (including 8 years).
According to the ROME III diagnostic criteria of functional constipation or guideline for diagnosis and treatment of chronic constipation in China (2013 edition), chronic constipation was diagnosed clinically. The duration of constipation was more than 6 months (including 6 months).
The age ranged from 18 to 70 years (including 18 and 70 years) with no restriction of sex.
Fasting blood glucose was no more than 8mmol/L and glycosylated hemoglobin ranged from 7.0% to 10.0% (including 7.0% and 10.0%).
Sign written consent form voluntarily.
Exclusion Criteria:
Other types of diabetes mellitus.
History of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome.
Constipation induced by drugs[i.e. antidepressants, calcium antagonists, diuretics, sympathetic agents, antacids with aluminum or calcium, calcium agents, iron agents, antidiarrhetics].
Organic constipation [i.e. intestinal diseases，endocrine and metabolic diseases (except diabetes), nervous system and muscle disease].
Gastrointestinal diseases [i.e. colitis, mesenteric lymphadenitis, with a history of intestinal surgery].
Using drugs that may affect clinical outcome evaluation in the past 2 weeks, such as antibiotics (penicillin, amoxicillin, erythromycin, azithromycin and cephalosporin, etc.), microecological preparations, laxative drugs (magnesium sulfate and lactulose, etc.); anthraquinones (rhubarb, aloe and senna, etc.); Gastrointestinal motility drugs (metoclopramide, domperidone, cisapride, etc).
History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk.
Abnormal liver function [i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value]. Abnormal renal function [Creatinine exceeds the upper limit of normal value].
Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure < 90/50 mmHg).
History of acute and chronic gastroenteritis or gastrointestinal surgery
Psychosis, alcohol dependence or history of drug abuse.
Lactating women, pregnant women and patients who have pregnancy plan during the trial or within 3 months after the trial.
Participation in other studies three months before the trial.
Allergic constitution or allergic to a variety of drugs.
Those researchers think inappropriate to the research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weigang Zhao, MD
Phone
+86 69151876
Email
xiehezhaoweigang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weigang Zhao, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weigang Zhao, MD
Phone
+86 69151876
Email
xiehezhaoweigang@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation
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