Urticaria
Conditions
Interventions
Treatment group:FMT+ external calamine lotion + external medical emollient
Placebo group:Gastrointestinal endoscopy and normal saline injection + external calamine lotion + external medical emollient
Control group:Cloratadine 10mg orally 1/ d
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the study, comply with the study requirements, sign the informed consent form, and have the intention and ability to complete the schedule record for more than 80% of the study period; 2. Males or females, aged 18 to 65 years; 3. More than 6 months after the diagnosis of chronic urticaria, patients still had at least 2 episodes of anemone and pruritus per week after taking the recommended dose of H1 receptor antihistamine regularly for 6 weeks before inclusion; 4. Pruritus VAS<7 points; 5. Accompanied by chronic constipation or chronic diarrhea and other gastrointestinal symptoms for more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Induced chronic urticaria, such as: artificial urticaria, cold sex urticaria, delay pressure sex urticaria, hot sex urticaria, solar sex urticaria, vibration sex urticaria and angioedema, cholinergic urticaria, water sex urticaria, sex urticaria, exercise induced urticaria with clear incentives; 2. Other diseases associated with urticaria or vascular edema, such as urticaria vasculitis, polymorphic erythema, mast cell hyperplasia, hereditary or acquired angioedema, lymphoma, leukemia and generalized tumors; 3. Within 7-14 days before enrollment, the uas7-day total score (UAS7) >20 points, or the total score of itch symptoms 14 points, or the itch score/ventilator score in one day or more=3; 4. Patients who are in the active stage of atopic dermatitis, bullous pemphigoid, herpetic dermatitis, pruritus senile or other skin diseases with obvious itching, or who have a previous medical history of the above diseases; 5. Those who were active in infectious diseases (except colds) within 2 weeks before enrollment; Previous history of chronic or recurrent infectious diseases; 6. Those who have received immunosuppressive agents, biological agents and systemic glucocorticoid treatment within 30 days before enrollment; For those who use the following drugs for continuously within 30 days or at least 5 days every other day: topical corticosteroids (prescription or over prescription), hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide and other immunomodulators; Patients who have received intravenous injection of immunoglobulin or plasma exchange within 30 days; 7. Patients who underwent surgery for other diseases or may be required to undergo surgery within 2 months before enrollment; Those who have received or are about to receive live vaccines within 6 weeks; Used antimicrobial drugs, probiotics, large doses of vitamins within 30 days, and received treatment to regulate intestinal microecology; If you are using other experimental drugs at the time of enrollment or within 5 times half-life of the experimental drugs or within 30 days (whichever is the older); 8. Previous allergic history of loratadine or local anesthetic drugs; A history of anaphylactic shock; 9. Pregnancy or recent pregnancy preparation is possible; Women who are likely to have children (defined as all women who are physically able to become pregnant, unless an effective contraceptive method is used throughout the study period (specific agreement is made in the protocol on the possibility of having children and the effective contraceptive method); Pregnant or lactating women (pregnancy is defined as the state of a woman after conception and before termination of pregnancy, subject to positive results of hCG laboratory tests). 10. Important viscera serious problems: including but not limited to cardiovascular (uncontrolled hypertension, systolic blood pressure, 160 MMHG or 95 MMHG or higher and /or diastolic blood pressure, heart failure: New York heart association class III/IV), nervous system, liver, kidney (serum creatinine level > 2.0 mg/dl (176.8 u mol/L), the blood system (into a group of white blood cells (WBC) count when < 2500 / mu L, or platelets < 100000 / mu L or neutrophils < 1500 / mu L or hemoglobin < 8.5 g/dl) disease; Previous history of lymphoproliferative disease; Patients with a history of malignancy within the first 5 years of admission (except for Bowen's disease, basal cell carcinoma, actinic keratosis and resected carc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Structure and diversity of faeces, intestinal mucosa and skin microflora;Immunological and cytological indicators;Allergen test;Adverse event;UAS7;VAS itch score;5D itch scale;DPS;DLQI scale;CU-Q2oL;MOS-SS sleep scale;Patient and observer satisfaction; | — |
Countries
China
Contacts
Public ContactHua Zhao
Department of Dermatology, PLA General Hospital
Outcome results
None listed