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Trial record 5 of 13 for:    probiotics | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | Diabetes Mellitus

Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03556631
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Shenzhen People's Hospital

Brief Summary:
Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of live combined Bifidobacterium and Lactobacillus preparation on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Probiotics Drug: live combined Bifidobacterium and Lactobacillus Tablets Phase 4

Detailed Description:

Design A randomized, single-blind, parallel-group, controlled clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 30 participants with type 1 diabetes, aged 18-60 years, will be recruited and randomly assigned to receive either probiotics (n = 15) or placebo (n = 15) for 12 weeks.

Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention and between groups.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Diabetes‑Related Outcomes in People With Type 1 Diabetes:a Single-blind Randomized Controlled Trial
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: probiotics group
live combined Bifidobacterium and Lactobacillus tablets were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
Drug: live combined Bifidobacterium and Lactobacillus Tablets
take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day
Other Name: probiotics

Placebo Comparator: placebo group
placebo were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
Drug: live combined Bifidobacterium and Lactobacillus Tablets
take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day
Other Name: probiotics




Primary Outcome Measures :
  1. hemoglobin A1c in percentage [ Time Frame: 3 months ]
    analyze the change of hemoglobin A1c between two groups


Secondary Outcome Measures :
  1. weight in kilograms [ Time Frame: 3 months ]
    analyze the change of weight in kilograms between two groups



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

type 1 diabetes patients ,age 18-60years old,18 Kg/m2≤BMI≤30Kg/m2, 7.0mmol/L<fasting blood glucose <13.0mmol/L;HbA1c≤10%,ketonuria (-);

Exclusion Criteria:

pregnancy, lactation, having other severe chronic illnesses.taking other anti-diabetic drugs


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556631


Contacts
Contact: Xiuzhen Zhang 86-13714902238 876538754@qq.com
Contact: Ping Xu 86-13692156916

Sponsors and Collaborators
Shenzhen People's Hospital
Investigators
Principal Investigator: Ping Xu associate chief physician

Responsible Party: Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT03556631     History of Changes
Other Study ID Numbers: SZLY2018009
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases