Type 2 Diabetes Mellitus With ComplicationPhase 4NCT04982380
Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation
A Phase 4 study testing Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live and Siliankang simulating tablets in people with Type 2 Diabetes Mellitus With Complication, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus With Complication
- What is being tested?
- Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live and Siliankang simulating tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2021to 31 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Weigang Zhao, MD, +86 69151876, xiehezhaoweigang@163.com
About this study
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
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.
Read the 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.
- Being tested
- Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live, Siliankang simulating tablets
- Keywords
- Type 2 diabetes;Constipation;Gut microbiota;Bifidobacterium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, LiveDrug
Also called Siliankang
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.
Siliankang simulating tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Drug: Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live |
| Control group | Placebo comparator | 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. Receives: Drug: Siliankang simulating tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Glycosylated hemoglobin
Changes from baseline in glycosylated hemoglobin.
Measured: Baseline, Week 12, Week 16
Glycosylated albumin
Changes from baseline in glycosylated albumin.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Secondary outcomes (9)
Gut micobiota
Changes from baseline in gut microbiota.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Week 1 to Week 16
Fasting blood glucose
Changes from baseline in fasting blood glucose.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Serum lipid spectrum
Changes from baseline in serum lipid spectrum.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start31 Jul 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With ComplicationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Sponsor
- Investigators
- Weigang Zhao, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982380
- Sponsor's protocol ID
- SLK-HS2843
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04982380
- Acronym / sponsor ID
- SLK-HS2843
- Keywords
- Type 2 diabetes;Constipation;Gut microbiota;Bifidobacterium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- 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.
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, LivePatients 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. |
| Control group | Placebo comparator | Drug: Siliankang simulating tabletsPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, LiveAlso: SiliankangPatients 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. | Drug | Experimental group |
| Siliankang simulating tabletsPatients 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. | Drug | Control group |
Primary outcome
Number of bowel movements
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
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
Time frame: Baseline, Week 12, Week 16
Changes from baseline in glycosylated hemoglobin.
Glycosylated albumin
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Changes from baseline in glycosylated albumin.
9 secondary outcomes
Gut micobiota
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
The ratio of CSBMs to SBMs
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Bristol Stool Scale
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Bowel Function Index (BFI)
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Patient Assessment of Constipation symptom (PAC-SYM)
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Patient global impression of changes (PGIC)
Time frame: Week 16
The first time of CSBM
Time frame: Week 1 to Week 16
Fasting blood glucose
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Serum lipid spectrum
Time frame: Baseline, Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weigang Zhao, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live and Siliankang simulating tablets in people with Type 2 Diabetes Mellitus With Complication, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weigang Zhao, MD (+86 69151876, xiehezhaoweigang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bowel movements (time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.