NCT06103240

Brief Summary

Purpose: to verify the physiological properties of Lactobacillus rhamnosus LRa05. Bacterial count:100 billion Test Objective: to test and collect the changes of intestinal flora before and after the daily use of LRa05 product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2022

Completed
1.4 years 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

Intestinal Flora

Outcome Measures

Primary Outcomes (1)

  • intestinal flora test

    Subjects took a packet of probiotics every day. Before taking probiotics, two weeks after taking probiotics, and after taking probiotics, fecal samples were collected, and fecal 16s rRNA was extracted using a DNA kit.

    4 weeks

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

Bacterial count：100 billion CFUs Take one sachet per day for 4 weeks.

Other: Lacticaseibacillus rhamnosus LRa05

Placebo group

PLACEBO COMPARATOR

maltodextrin

Other: Lacticaseibacillus rhamnosus LRa05

Interventions

Lacticaseibacillus rhamnosus LRa05OTHER

Bacterial count:100 billion CFUs Take one sachet per day for 4 weeks.

Placebo groupProbiotic group

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PSQI Pittsburgh Sleep Quality Index scale score \>6 and \<18
  • ISI Insomnia Severity Index scale score \>8 and \<23

You may not qualify if:

  • People 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 oily are not recommended to participate in the test; people with special dietary structure (e.g. ketogenic diet, etc.) caused by weight loss or other reasons, such as muscle gain and fat loss, are not recommended to participate in the test;
  • others with special conditions are not recommended to participate, such as those who are allergic to probiotic products;
  • pregnant women, lactating women and people under 19 and over 45 years old should not experiment;
  • people with unhealthy stomach and intestines are not recommended to participate in the test;
  • people with low body fat and BMI \<23 are not recommended to participate in the test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan University of Technology

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, 2022

Primary Completion

April 25, 2022

Study Completion

June 11, 2022

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)