Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease

NCT ID: NCT05492448

Last Updated: 2025-03-18

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

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2025-12-31

Brief Summary

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This trial is a randomized, double-blind, parallel placebo clinical trial, the purpose of which is to investigate whether the adjuvant therapy of using probiotics during the treatment of diabetic patients can decrease blood sugar levels significantly in comparison with placebo, and observe if the reduced lung function could be recovered in patients with type 2 diabetes (T2DM) and chronic obstructive pulmonary disease (COPD) simultaneously.

Detailed Description

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Conditions

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Type 2 Diabetes Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Subjects take one pack containing maltodextrin twice daily after breakfast and dinner.

L. salivarius AP-32 and L. reuteri GL-104

Group Type EXPERIMENTAL

L. salivarius AP-32 and L. reuteri GL-104

Intervention Type DIETARY_SUPPLEMENT

Subjects take one pack containing L. salivarius AP-32 and L. reuteri GL-104 twice daily after breakfast and dinner.

L. reuteri GL-104

Group Type EXPERIMENTAL

L. reuteri GL-104

Intervention Type DIETARY_SUPPLEMENT

Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner.

Interventions

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L. salivarius AP-32 and L. reuteri GL-104

Subjects take one pack containing L. salivarius AP-32 and L. reuteri GL-104 twice daily after breakfast and dinner.

Intervention Type DIETARY_SUPPLEMENT

L. reuteri GL-104

Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subjects take one pack containing maltodextrin twice daily after breakfast and dinner.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Subjects are between 50-85 years old, and clinical diagnosis of T2DM (HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL or oral glucose tolerance test 2-hour plasma glucose ≥ 200 mg/dL).
* Patients with stable pulmonary obstruction (pulmonary function FEV1/FVC \<0.7) with symptoms of pulmonary obstruction.
* Subjects can cooperate with the collection of experimental specimens and return for regular visits.
* The patient or family members have signed the informed consent form.
* The patient must receive adjuvant treatment with probiotic for 12 weeks.

Exclusion Criteria

* The patient or caregiver is unable to follow the physician's instructions for the trial, including the completed symptom assessment form and compliance with medication.
* The patient has a history of related allergic reactions, or the use of other highly sensitive or contraindicated drugs (Allergy to antibiotics or antipyretics).
* The patient have taken oral immunosuppressive drugs, intravenous steroids or T cell inhibitor ointments within the past 2 weeks.
* The patient has consumed probiotic-related products (including drops, lozenges, capsules, powder and yogurt) within the past 1 month.
* The patient received high doses of steroids within the past 1 month.
* The patient with active infection or severe pulmonary disease (eg, tuberculosis, bronchiectasis, or fibrosis).
* The patient is receiving treatment for a major disease or congenital disease.
* The patient is not suitable to participate in the trial as assessed by the professional physician.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glac Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Hsieh-Hsun Ho

R&D Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Glac Biotech Co., Ltd.

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Feng Wei, M.D., Ph.D

Role: CONTACT

886-7-6150011

Yao-Tsung Yeh, Ph.D

Role: CONTACT

886-7-7811151 ext. 6800

Facility Contacts

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Hsieh-Hsun Ho, Ph. D

Role: primary

886-6-5891871 ext. 6230

Yi-Wei Kuo, Master

Role: backup

886-6-5891871 ext. 6231

Other Identifiers

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EMRP12110N

Identifier Type: -

Identifier Source: org_study_id

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