NCT02728414

Brief Summary

The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

March 25, 2016

Last Update Submit

March 9, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2, Probiotics, Treatment

Outcome Measures

Primary Outcomes (4)

  • change from baseline in fasting blood-glucose at 1 month

    change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline

    1 month

  • change from baseline in fasting blood-glucose at 3 months

    change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline

    3 months

  • change from baseline in glycosylated hemoglobin change at 1 month

    change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline

    1 month

  • change from baseline in glycosylated hemoglobin change at 3 months

    change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline

    3 months

Secondary Outcomes (32)

  • change from baseline in gut microbiota at 1 month

    1 month

  • change from baseline in gut microbiota at 3 months

    3 months

  • change from baseline in triglyceride at 1 month

    1 month

  • change from baseline in triglyceride at 3 months

    3 months

  • change from baseline in cholesterol at 1 month

    1 month

  • +27 more secondary outcomes

Study Arms (2)

probiotics

EXPERIMENTAL

the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.

Dietary Supplement: probiotics

placebo

OTHER

the patients in this arm will receive placebo with similar appearance of probiotics.

Dietary Supplement: placebo

Interventions

probioticsDIETARY_SUPPLEMENT

the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.

probiotics
placeboDIETARY_SUPPLEMENT

the patients in this arm will receive placebo intervention

placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-80 years
  • Confirmed type 2 diabetes patients with Oral antidiabetic agents
  • Agree to cooperate in the trial
  • Provision of written informed consent

You may not qualify if:

  • With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance
  • Type 1 diabetes
  • Treated with insulin or an insulin analogue in the last 6 months
  • Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones
  • Use any probiotics in the last 3 months
  • Participating in any other clinical trials
  • Was not able to insist until the end
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Huanlong Qin, PhD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cuiling Zhu, MD

CONTACT

18817951953l1263856671@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2016

First Posted

April 5, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

CN(1)