Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease

February 25, 2026 updated by: Hsieh-Hsun Ho, Glac Biotech Co., Ltd

A Randomized Double-Blind Controlled Study Comparing the Effects of Probiotic Adjuvant Therapy on the Improvement of Lung Function and Blood Sugar in Patients With Type 2 Diabetes and Chronic Obstruction Pulmonary Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan, 74442
        • Glac Biotech Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Dietary supplement: Placebo
Subjects take one pack containing maltodextrin twice daily after breakfast and dinner.
Experimental: L. salivarius AP-32 and L. reuteri GL-104
Dietary supplement: 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.
Experimental: L. reuteri GL-104
Dietary supplement: L. reuteri GL-104
Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in concentration of glycated hemoglobin (HbA1c).
Time Frame: Before and after 4-, 12-week intervention.
Changes in concentration of HbA1c were assessed before and after 4-, 12-week intervention.
Before and after 4-, 12-week intervention.
Changes in ratio of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).
Time Frame: Before and after 4-, 12-week intervention.
Changes in ratio of FEV1/FVC were assessed by bronchodilator test before and after 4-, 12-week intervention.
Before and after 4-, 12-week intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in concentration of fasting blood sugar.
Time Frame: Before and after 4-, 12-week intervention.
Changes in concentration of fasting blood sugar were assessed before and after 4-, 12-week intervention.
Before and after 4-, 12-week intervention.
Changes in concentration of immune cytokines.
Time Frame: Before and after 4-, 12-week intervention.
Changes in concentration of immune cytokines were assessed before and after 4-, 12-week intervention.
Before and after 4-, 12-week intervention.
Changes in scores of modified medical research council (mMRC).
Time Frame: Before and after 4-, 12-week intervention.
Changes in scores of mMRC were assessed before and after 4-, 12-week intervention. The minimum score is 0 and the maximum score is 4. A higher score means more difficult breathing.
Before and after 4-, 12-week intervention.
Changes in scores of COPD assessment test (CAT).
Time Frame: Before and after 4-, 12-week intervention.
Changes in scores of CAT were assessed before and after 4-, 12-week intervention. The minimum score is 0 and the maximum score is 40. A higher score means more seriously affect life.
Before and after 4-, 12-week intervention.
Changes of the composition in gut microbiota.
Time Frame: Before and after 12-week intervention.
Changes of the composition in gut microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Before and after 12-week intervention.
Changes of the composition in lower respiratory tract microbiota.
Time Frame: Before and after 12-week intervention.
Changes of the composition in lower respiratory tract microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Before and after 12-week intervention.
Changes of concentration in short-chain fatty acid (SCFA) on plasma.
Time Frame: Before and after 12-week intervention.
Changes of concentration in SCFA on plasma were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Before and after 12-week intervention.
Changes of concentration in short-chain fatty acid (SCFA) on stool.
Time Frame: Before and after 12-week intervention.
Changes of concentration in SCFA on stool were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Before and after 12-week intervention.
Changes in scores of modified Bristol stool form scale.
Time Frame: Before and after 4-, 12-week intervention.
Changes in scores of modified Bristol stool form scale were assessed before and after 4-, 12-week intervention. The questionnaire included the stool form [1 = very hard (small hard lumps), 2 = hard stool (hard sausage shape), 3 = normal stool (sausage to banana shape), 4 = soft stool, 5 = muddy stool, 6 = watery stool], ease of defecation (1 = difficult, 2 = easy, 3 = very easy) and abdominal symptoms [frequency of upper abdominal pain, lower abdominal pain, borborygmus, and flatulence (1 = frequent, 2 = occasional, 3 = almost never)].
Before and after 4-, 12-week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glac Biotech Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EMRP12110N

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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