Effect of oral administration of Bacillus coagulans strain TBC169 on the intestinal microbiome of patients with moderate-to-severe acne and assessment of clinical efficacy

Effect of oral administration of Bacillus coagulans strain TBC169 on the intestinal microbiome of patients with moderate-to-severe acne and assessment of clinical efficacy: a randomised, double-blind, placebo-controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500098997

Enrollment

Unknown

Registered

2025-03-17

Start date

2024-01-02

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acne

Interventions

Test group:Oral live Bacillus coagulans tablets 1050mg tid

Control group 1:Oral placebo 1050mg tid

Control group 2:Oral placebo 1050mg tid

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of moderately severe (grades II, III, and IV) acne according to the Pillsbury classification criteria. 1. Healthy person aged 18-45 years old, male or female. 2. Candidates for systemic therapy with isotretinoin who have not taken oral medication for acne within 3 months. 3. Be able to follow up regularly for 1 month and maintain a regular lifestyle during the trial period, ensuring that you do not use cosmetics, and skincare and cleansing products other than those permitted by your doctor. 4. Be able to communicate well with the investigator and comply with the requirements of the study, participate voluntarily and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of other skin diseases: contact dermatitis, atopic dermatitis, eczema, psoriasis, acanthosis nigricans, fungal infections of the skin, urticaria, etc. 2. Acne variants: violaceous acne, coalescent acne, etc. 3. Presence of systemic diseases: immunodeficiency or any other immune disorder, allergic diseases, metabolic diseases (e.g. obesity, fatty liver, diabetes mellitus, polycystic ovary syndrome), malignant neoplasms, any other serious visceral disease, psychiatric disorders, history of gastro-intestinal surgery. 4. Pregnant and breastfeeding women and those who plan to have children within six months. 5. Hypersensitivity to the study drug, or allergies. 6. Prolonged systemic use of probiotic food and drugs, antibiotics, retinoids, corticosteroids, immunosuppressants, antacids, non-steroidal anti-inflammatory drugs or herbal medicines within 3 months. 7. Those who are participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
Acne severity score (GSRS);Characterisation of the diversity and composition of the intestinal flora;VISIA Skin Non-Invasive Testing Physiological Indicators;	—

Secondary

Measure	Time frame
Dermatological Quality of Life Index (DLQI);Gastrointestinal symptom severity (GSRS);Serum cytokine levels;	—

Countries

China

Contacts

Public ContactRen Jianwen

The Second Affiliated Hospital of Xi'an Jiaotong University

yangjunlan21@163.com+86 153 9906 3903

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026