Type 2 DiabetesNCT05492448
Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease
A study testing L. salivarius AP-32 and L. reuteri GL-104 and L. reuteri GL-104 in people with Type 2 Diabetes and Chronic Obstructive Pulmonary Disease, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Type 2 Diabetes, Chronic Obstructive Pulmonary Disease
- What is being tested?
- L. salivarius AP-32 and L. reuteri GL-104 and L. reuteri GL-104
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Placebo, L. salivarius AP-32 and L. reuteri GL-104, L. reuteri GL-104
- Keywords
- Diabetes mellitus, Chronic obstructive pulmonary disease, Gut microbiota, Probiotics
- Medical subject headings
- Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Subjects take one pack containing maltodextrin twice daily after breakfast and dinner.
L. salivarius AP-32 and L. reuteri GL-104Dietary supplement
Subjects take one pack containing L. salivarius AP-32 and L. reuteri GL-104 twice daily after breakfast and dinner.
L. reuteri GL-104Dietary supplement
Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| L. salivarius AP-32 and L. reuteri GL-104 | Experimental | Not described Receives: Dietary Supplement: L. salivarius AP-32 and L. reuteri GL-104 |
| L. reuteri GL-104 | Experimental | Not described Receives: Dietary Supplement: L. reuteri GL-104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in concentration of glycated hemoglobin (HbA1c).
Changes in concentration of HbA1c were assessed before and after 4-, 12-week intervention.
Measured: Before and after 4-, 12-week intervention.
Changes in ratio of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).
Changes in ratio of FEV1/FVC were assessed by bronchodilator test before and after 4-, 12-week intervention.
Measured: Before and after 4-, 12-week intervention.
Secondary outcomes (9)
Changes in concentration of fasting blood sugar.
Changes in concentration of fasting blood sugar were assessed before and after 4-, 12-week intervention.
Measured: Before and after 4-, 12-week intervention.
Changes in concentration of immune cytokines.
Changes in concentration of immune cytokines were assessed before and after 4-, 12-week intervention.
Measured: Before and after 4-, 12-week intervention.
Changes in scores of modified medical research council (mMRC).
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.
Measured: Before and after 4-, 12-week intervention.
Changes in scores of COPD assessment test (CAT).
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.
Measured: Before and after 4-, 12-week intervention.
Changes of the composition in gut microbiota.
Changes of the composition in gut microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Measured: Before and after 12-week intervention.
Changes of the composition in lower respiratory tract microbiota.
Changes of the composition in lower respiratory tract microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Measured: Before and after 12-week intervention.
Changes of concentration in short-chain fatty acid (SCFA) on plasma.
Changes of concentration in SCFA on plasma were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Measured: Before and after 12-week intervention.
Changes of concentration in short-chain fatty acid (SCFA) on stool.
Changes of concentration in SCFA on stool were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Measured: Before and after 12-week intervention.
Changes in scores of modified Bristol stool form scale.
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)].
Measured: Before and after 4-, 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start19 Sep 2022
- Primary completion15 Aug 2025
- Study completion31 Dec 2025
Why it stopped: Insufficient funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hsieh-Hsun Ho, Glac Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492448
- Sponsor's protocol ID
- EMRP12110N
- Status last verified
- Mar 2025
- First submitted
- 1 Aug 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05492448
- Acronym / sponsor ID
- EMRP12110N
- Keywords
- Diabetes mellitus, Chronic obstructive pulmonary disease, Gut microbiota, Probiotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funds
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Glac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| L. salivarius AP-32 and L. reuteri GL-104 | Experimental | Dietary Supplement: L. salivarius AP-32 and L. reuteri GL-104 |
| L. reuteri GL-104 | Experimental | Dietary Supplement: L. reuteri GL-104 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects take one pack containing maltodextrin twice daily after breakfast and dinner. | Dietary supplement | Placebo |
| L. salivarius AP-32 and L. reuteri GL-104Subjects take one pack containing L. salivarius AP-32 and L. reuteri GL-104 twice daily after breakfast and dinner. | Dietary supplement | L. salivarius AP-32 and L. reuteri GL-104 |
| L. reuteri GL-104Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner. | Dietary supplement | L. reuteri GL-104 |
Primary outcome
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.
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.
9 secondary outcomes
Changes in concentration of fasting blood sugar.
Time frame: Before and after 4-, 12-week intervention.
Changes in concentration of immune cytokines.
Time frame: 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 COPD assessment test (CAT).
Time frame: 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 lower respiratory tract microbiota.
Time frame: 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 short-chain fatty acid (SCFA) on stool.
Time frame: Before and after 12-week intervention.
Changes in scores of modified Bristol stool form scale.
Time frame: Before and after 4-, 12-week intervention.
Results and safety
The study was stopped early (reason given: Insufficient funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. salivarius AP-32 and L. reuteri GL-104 and L. reuteri GL-104 in people with Type 2 Diabetes and Chronic Obstructive Pulmonary Disease, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient funds). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in concentration of glycated hemoglobin (HbA1c). (time frame: Before and after 4-, 12-week intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.