Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease

Sponsor

Glac Biotech Co., Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05492448

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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 could be recovered in patients with type 2 diabetes (T2DM) and chronic obstructive pulmonary disease (COPD) simultaneously.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Chronic Obstructive Pulmonary Disease	Dietary Supplement: Placebo Dietary Supplement: L. salivarius and L. reuteri Dietary Supplement: L. reuteri	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Dietary Supplement: Placebo Subjects take one pack containing maltodextrin twice daily after breakfast and dinner.
Experimental: L. salivarius and L. reuteri	Dietary Supplement: L. salivarius and L. reuteri Subjects take one pack containing L. salivarius and L. reuteri twice daily after breakfast and dinner.
Experimental: L. reuteri	Dietary Supplement: L. reuteri Subjects take one pack containing L. reuteri twice daily after breakfast and dinner.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Dietary Supplement: Placebo

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

Experimental: L. salivarius and L. reuteri

Dietary Supplement: L. salivarius and L. reuteri

Subjects take one pack containing L. salivarius and L. reuteri twice daily after breakfast and dinner.

Experimental: L. reuteri

Dietary Supplement: L. reuteri

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

Outcome Measures

Primary Outcome Measures

Changes in concentration of glycated hemoglobin (HbA1c). [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). [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.

Secondary Outcome Measures

Changes in concentration of fasting blood sugar. [Before and after 4-, 12-week intervention.]
Changes in concentration of fasting blood sugar were assessed before and after 4-, 12-week intervention.
Changes in concentration of immune cytokines. [Before and after 4-, 12-week intervention.]
Changes in concentration of immune cytokines were assessed before and after 4-, 12-week intervention.
Changes in scores of modified medical research council (mMRC). [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.
Changes in scores of COPD assessment test (CAT). [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.
Changes of the composition in gut microbiota. [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.
Changes of the composition in lower respiratory tract microbiota. [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.
Changes of concentration in short-chain fatty acid (SCFA) on plasma. [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.
Changes of concentration in short-chain fatty acid (SCFA) on stool. [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.
Changes in scores of modified Bristol stool form scale. [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)].

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.