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A randomized, double-blind, placebo-controlled, single center clinical trial of fecal microbiota transplantation in the treatment of moderate to severe atopic dermatitis

A randomized, double-blind, placebo-controlled, single center clinical trial of fecal microbiota transplantation in the treatment of moderate to severe atopic dermatitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047842
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-08-30

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

Conditions

Atopic dermatitis

Interventions

Sponsors

Hospital for Skin Diseases(Institute of Dermatology)Chinese Academy of Medical Sciences, Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Meet the Hanifin-Rajka diagnostic criteria (see appendix 1), exclude infection, tumor and other connective tissue diseases and diagnose AD patients. 3. Meet the SCORAD (see Annex 2) score of >=40 points during the screening period; 4. Those who signed the informed consent form voluntarily participated in this project and were able to complete the follow-up as required.

Exclusion criteria

Exclusion criteria: 1. Suffering from malignant tumor or a history of malignant tumor within 5 years before screening; 2. There are other inflammatory skin diseases that may interfere with the evaluation of efficacy, including but not limited to psoriasis, parapsoriasis, eosinophilic dermatitis, seborrheic dermatitis, contact dermatitis, etc.; 3. Patients with serious heart, brain, lung, liver, kidney, blood and other important organ system diseases, and the researchers believe that they are not suitable to participate in this study; 4. Received systemic glucocorticoid, tripterygium, cyclosporine, methotrexate and other immunosuppressive therapy within 4 weeks before the first transplantation of the study, or received biological agent therapy within 3 months, such as Dupril Uzumumab and omalizumab, etc.; 5. Those who have used antimicrobial drugs, probiotics/meta-preparations, therapy to regulate intestinal microecology, and other drugs that have a greater impact on intestinal flora within 4 weeks; 6. Known active or recurrent serious infection such as active tuberculosis; 7. Congenital immunodeficiency or congenital immunosuppression; 8. Patients with drug addiction, alcohol abuse or mental disorders, unable to cooperate or adhere to treatment, and poor predictability; 9. Pregnant women, pregnant women and lactating women; 10. The patient is participating in other clinical trials at the same time; 11. Any person who is considered inappropriate by the investigator to participate in this trial for other reasons.

Design outcomes

Secondary

MeasureTime frame
Eczema Area and Severity Index;Atopic Dermatitis Score;Overall Investigator Assessment;Atopic Dermatitis Evaluation Tool;Dermatology Life Quality Index;Visual Analog Pain Score;Patient Eczema Self-Examination Rating Scale;Hospital Anxiety and Depression Scale;The proportion of Th cell subsets and the changes of serum effector cytokines;total IgE;

Primary

MeasureTime frame
Eczema Area and Severity Index 50 Response Ratio;

Countries

China

Contacts

Public ContactYao Xu

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College

dryao_xu@126.com+86 25 85478089

Outcome results

None listed

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