NCT07325409

Brief Summary

To evaluate the clinical efficacy of Weizmannia coagulans BC99 in young Chinese patients with exercise-induced muscle damage compared with placebo, and to explore its effects on inflammatory responses and intestinal microbiota.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 24, 2025

Last Update Submit

December 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain evaluation

    Visual analog scale (VAS) was used for assessing the pain level of muscle, ranging from 0 to 10 point (0 means no pain; 10 represent worst imaginable pain). VAS scores were recorded at 24h, 48h and 72h after the intense exercise work stress.

    12 weeks

Secondary Outcomes (2)

  • Cortisol in plasma

    12 weeks

  • Peptide YY in plasma

    12 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

3g dose of milk protein concentrate/pack, 8 packs per day

Dietary Supplement: Placebo

BC99 group

EXPERIMENTAL

3g dose of milk protein concentrate with 6×109 Colony Forming Unit (CFU) W. coagulans BC99/pack, 8 packs per day

Dietary Supplement: BC99

Interventions

PlaceboDIETARY_SUPPLEMENT

The experimental phase of this study lasts 12 weeks and each participant will have 3 visits (week 0, week 6, week 12)

Placebo group
BC99DIETARY_SUPPLEMENT

The experimental phase of this study lasts 12 weeks and each participant will have 3 visits (week 0, week 6, week 12)

BC99 group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 19-35 years, with no restriction on sex;
  • Physically active individuals with regular daily exercise training intensity and duration;
  • No history of allergy to protein products;
  • Body weight ≥50 kg for male subjects and ≥45 kg for female subjects; body mass index (BMI), calculated as weight (kg) divided by height squared (m²), within the range of 19.0-24.0 kg/m²;
  • No history of cardiovascular or cerebrovascular diseases, hypertension, diabetes, hepatic or renal dysfunction, or other underlying diseases or metabolic disorders;
  • Willingness to comply with the study protocol and study restrictions, and voluntary provision of written informed consent to participate in the study.

You may not qualify if:

  • History of allergic constitution or immunodeficiency;
  • Blood donation or significant blood loss (≥200 mL) within 3 months prior to administration of the investigational product;
  • Presence of severe diseases of major organs, including the cardiovascular system, lungs, liver, or kidneys, as well as diabetes mellitus, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system diseases;
  • Use of medications affecting the intestinal microbiota (including antibiotics, microecological preparations, intestinal mucosal protectants, traditional Chinese medicines, etc.) for more than one consecutive week within 1 month prior to screening;
  • Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wu Ying

Luoyang, Henan, 471000, 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

December 24, 2025

First Posted

January 8, 2026

Study Start

November 1, 2023

Primary Completion

March 10, 2024

Study Completion

March 28, 2024

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations