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

NCT ID: NCT03556631

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Probiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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probiotics group

live combined Bifidobacterium and Lactobacillus tablets were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months

Group Type EXPERIMENTAL

live combined Bifidobacterium and Lactobacillus Tablets

Intervention Type DRUG

take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day

placebo group

placebo were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months

Group Type PLACEBO_COMPARATOR

live combined Bifidobacterium and Lactobacillus Tablets

Intervention Type DRUG

take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day

Interventions

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live combined Bifidobacterium and Lactobacillus Tablets

take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day

Intervention Type DRUG

Other Intervention Names

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probiotics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ping Xu

Role: PRINCIPAL_INVESTIGATOR

associate chief physician

Locations

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Shenzhen People' S Hospital

Shenzhen, , China

Site Status

Countries

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China

Other Identifiers

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SZLY2018009

Identifier Type: -

Identifier Source: org_study_id

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