Effects of the Bifidobacterium Longum BL21 on BMI, Metabo... | NCT06140641

Studies
Effects of the Bifidobacterium Longum BL21 on BMI, Metabolic Indicators, and Gut Microbiota in Overweight/Obese Adults

NCT06140641

Sponsor

Qilu Hospital of Shandong University

Status

Unknown status

Last Update Posted

Nov 20, 2023Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Overweight/Obese Adults

Interventions

Probiotics

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2023Estimated

Primary Completion Date

Jul 30, 2024Estimated

Completion Date

Aug 30, 2024Estimated

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Nov 17, 2023

First Posted Date

Nov 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2023

Last Update Posted Date

Nov 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults.

The blood, urine, and feces samples of the subjects need to be collected at 0,4 and 8 week and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

Detailed Description

The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults. Randomized grouping was used to provide probiotic BL21 or placebo intervention. The total duration of the study is 8 weeks, including 8 weeks (1-8 weeks) of intervention expectations. The subjects were followed up at weeks 2 and 6, and sampled at weeks 0, 4, and 8. After the intervention during the follow-up period, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo group	Placebo Comparator	Daily administration of placebo for 8 weeks.	Dietary Supplement: Probiotics
Probiotics group	Experimental	Daily administration of Bifidobacterium Longum BL21 for 8 weeks.	Dietary Supplement: Probiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Dietary Supplement	Bifidobacterium Longum BL21 or placebo for 8 weeks.	Placebo group Probiotics group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of intervention with Bifidobacterium longum BL21 on the gut microbiota in overweight/obese adults	Take stool for microbial community sequencing	0, 4 and 8 week

Secondary Outcomes

Measure	Description	Time Frame
Effects of intervention with Bifidobacterium longum BL21 on the BMI in overweight/obese adults.	Record BMI	0, 4 and 8 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) ≥ 24kg/m2 indicates overweight, and BMI ≥ 28kg/m2 indicates obesity;
Willing to take the test formulation daily during the study period;
Subjects who understand clinical research and commit to complying with research requirements and procedures.

Exclusion Criteria:

Patients with serious chronic diseases (heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental disease and organ surgery history, diabetes, etc.) and complications;
Patients with severe allergies and immune deficiencies;
Pregnant, breastfeeding, or expectant women during the study period
Patients with a clear history of gastrointestinal diseases (ulcers, irritable bowel syndrome, etc.);
Have a history of intervention with lipid-lowering drugs or health products within the past 2 months;
Individuals who have used antibiotics within the past two weeks;
Failure to consume the test sample as required, or failure to follow up on time, resulting in uncertain efficacy
Subjects deemed unsuitable by other researchers to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Lixiang Li, PhD	Contact	+8618560082215		lilixiang@sdu.edu.cn

Name	Affiliation	Role
Tao Zhou, MD	Qilu Hospital of Shandong University	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40676704	Derived	Wang X, Xing Z, Wang R, Zhang G, Liu G, Li Z, Li L. Multi-omics analyses the effect of Bifidobacterium longum subsp. longum BL21 supplementation on overweight and obese subjects: a randomized, double-blind, placebo-controlled study. Nutr Metab (Lond). 2025 Jul 17;22(1):79. doi: 10.1186/s12986-025-00969-2.

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena