NCT06183801

Brief Summary

The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated fromseveral aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

December 4, 2023

Last Update Submit

December 13, 2023

Conditions

Metabolic Syndrome

Keywords

ProbioticsGut microbiotaMetabolic imbalancesSCFAs

Outcome Measures

Primary Outcomes (3)

  • blood biochemical indicators

    Detecting the changes of concentration in blood biochemical indexes . 1. glucose AC (mg/dL) 2. Glutamic Oxaloacetic Transaminase,GOT (U/L) 3. Glutamic Pyruvic Transaminase,GPT (U/L) 4. Blood urea nitrogen,BUN (mg/dL) 5. Creatinine (mg/dL) 6. Triglyceride,TG (mg/dL) 7. total cholesterol (mg/dL) 8. High-density lipoprotein,HDL (mg/dL) 9. Low-density lipoprotein,LDL (mg/dL)

    Day0、Day30、Day60、Day90、Day120、Day180

  • Changes in gut microbiota ratios

    Using Next-Generation Sequencing (NGS) to analyze the changes of fecal flora.

    Day0、Day30、Day60、Day90、Day120、Day180

  • Changes in gut aging index score(GAIS)

    Calculating probiotic/pathogenic ratios

    Day0、Day30、Day60、Day90、Day120、Day180

Secondary Outcomes (5)

  • Short chain fatty acid analysis

    Day0、Day30、Day60、Day90、Day120、Day180

  • Changes in sleep quality

    Day0、Day30、Day60、Day90、Day120、Day180

  • Evaluating the score difference of Gastrointestinal(GI) symptoms questionnaire

    Day0、Day30、Day60、Day90、Day120、Day180

  • Evaluating the score difference of Physical symptoms questionnaire

    Day0、Day30、Day60、Day90、Day120、Day180

  • Changes in stool form

    Day0、Day30、Day60、Day90、Day120、Day180

Study Arms (9)

Probiotic 1

EXPERIMENTAL

Subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Probiotics 1

Probiotic 2

EXPERIMENTAL

Subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Probiotics 2

Probiotic 3

EXPERIMENTAL

Subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Probiotics 3

Probiotic 4

EXPERIMENTAL

Subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Probiotics 4

Probiotic 5

EXPERIMENTAL

Subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Probiotics 5

Placebo 1

PLACEBO COMPARATOR

Subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Placebo 1

Probiotic 6

EXPERIMENTAL

After 1 month wash out,subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Probiotics 6

Probiotic 7

EXPERIMENTAL

After 1 month wash out,subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Probiotics 7

Placebo 2

PLACEBO COMPARATOR

After 1 month wash out,subjects take probiotics capsule three times a day before meal.

Dietary Supplement: Placebo 2

Interventions

Probiotics 1DIETARY_SUPPLEMENT

Subjects take probiotics capsule(Lactobacillus fermentum,TSF331) three times a day before meal.

Probiotic 1
Probiotics 2DIETARY_SUPPLEMENT

Subjects take probiotics capsule(Lactobacillus reuteri,TSR332) three times a day before meal.

Probiotic 2
Probiotics 3DIETARY_SUPPLEMENT

Subjects take probiotics capsule(Lactobacillus plantarum,TSP05) three times a day before meal.

Probiotic 3
Probiotics 4DIETARY_SUPPLEMENT

Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05) three times a day before meal.

Probiotic 4
Probiotics 5DIETARY_SUPPLEMENT

Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05+Postbiotics PE0401) three times a day before meal.

Probiotic 5
Placebo 1DIETARY_SUPPLEMENT

Subjects take capsule three times a day before meal.

Placebo 1
Probiotics 6DIETARY_SUPPLEMENT

After 1 month wash out, subjects take probiotics capsule(Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.

Probiotic 6
Probiotics 7DIETARY_SUPPLEMENT

After 1 month wash out, subjects take probiotics capsule(Lactobacillus rhamnosus, bv-77+Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.

Probiotic 7
Placebo 2DIETARY_SUPPLEMENT

After 1 month wash out, subjects take capsule three times a day before meal.

Placebo 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The subject are willing to provide physical examination reports within the past 1 year.
  • The subject are willing to sign informed consent form.

You may not qualify if:

  • Pregnant women or preparing for pregnancy.
  • The subject were taking antibiotics.
  • One of parents are not Han Chinese or aboriginal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glac Biotech Co., Ltd.

Tainan, 74442, Taiwan

Location

Related Publications (1)

  • Lin JH, Lin CH, Kuo YW, Liao CA, Chen JF, Tsai SY, Li CM, Hsu YC, Huang YY, Hsia KC, Yeh YT, Ho HH. Probiotic Lactobacillus fermentum TSF331, Lactobacillus reuteri TSR332, and Lactobacillus plantarum TSP05 improved liver function and uric acid management-A pilot study. PLoS One. 2024 Jul 24;19(7):e0307181. doi: 10.1371/journal.pone.0307181. eCollection 2024.

    PMID: 39046973DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Hsieh-Hsun Ho, Ph. D.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
R & D director

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 28, 2023

Study Start

August 1, 2021

Primary Completion

September 30, 2022

Study Completion

March 31, 2023

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations

TW(1)