NCT06103253

Brief Summary

The goal of this placebo-controlled randomized trial is to test the effect of intervention with Bifidobacterium animalis subsp. lactis BLa80 on the composition of the gut microbiota of healthy volunteers. The main question it aims to answer is whether probiotic can effectively regulate intestinal flora. Participants will take a package of probiotics every day, and their weight was recorded once a week using a weight scale. Blood and stool tests were conducted before and after taking probiotics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

5 days

First QC Date

October 21, 2023

Last Update Submit

October 21, 2023

Conditions

Healthy Adults

Keywords

ProbioticsGut microbiotaUric acid

Outcome Measures

Primary Outcomes (1)

  • gut microbiota diversity

    Before and after taking probiotics, subjects' stool was collected, and stool 16s rRNA was detected by DNA extraction kit.

    8 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

a placebo 27 group (maltodextrin)

Dietary Supplement: a Bla80 group

Probiotic group

ACTIVE COMPARATOR

a Bla80 group (maltodextrin + strain BLa80 in 10B /day)

Dietary Supplement: a Bla80 group

Interventions

a Bla80 groupDIETARY_SUPPLEMENT

the BLa80 group received 2.9 g of maltodextrin + 0.1 g of BLa80 bacterial powder 10B daily.

Placebo groupProbiotic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 21

You may not qualify if:

  • Those who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
  • People whose daily diet is too light or too greasy are not recommended to participate in the test; People with special dietary structure caused by weight loss or other reasons (such as ketogenic diet, etc.) are not recommended to participate in the test;
  • Other people with special circumstances are not recommended to participate, such as those who are allergic to probiotic products; Pregnant women, breastfeeding women and people under 19 years old and over 45 years old should not be tested.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Engineering Laboratory for Deep Processing of wheat and corn

Zhengzhou, Henan, 450001, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2023

First Posted

October 26, 2023

Study Start

April 20, 2023

Primary Completion

April 25, 2023

Study Completion

June 28, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

CN(1)