Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation

NCT04982380 | Unknown Phase 4

• 1 other identifier: SLK-HS2843
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus With Complication

Keywords

Type 2 diabetes;Constipation;Gut microbiota;Bifidobacterium

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Gut micobiota

  Baseline, Week 4, Week 8, Week 12, Week 16

• The ratio of CSBMs to SBMs

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

• Bristol Stool Scale

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

• Bowel Function Index (BFI)

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

• Patient Assessment of Constipation symptom (PAC-SYM)

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Study Arms (2)

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.

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.

Drug: Siliankang simulating tablets

Interventions

Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live DRUG

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.

Also known as: Siliankang

Experimental group

Siliankang simulating tablets DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• First Affiliated Hospital of Harbin Medical University: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• Affiliated Hospital of Chengde Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Chinese Academy of Sciences: collaborator
• Hangzhou Grand Biologic Pharmaceutical, Inc.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

Lacteol

Study Officials

• Weigang Zhao, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weigang Zhao, MD

CONTACT

+86 69151876; xiehezhaoweigang@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 29, 2021
• Study Start: July 31, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)