Clostridium Difficile İshali için Tanımlı Dışkı Mikrobiyota Nakli

Sade dilde özet

Bu çalışma, standart antibiyotik tedavisine (metronidazol veya vankomisin) yanıt vermeyen ya da tekrarlayan Clostridium difficile enfeksiyonuna (CDI) bağlı ishalde dışkı mikrobiyota nakli (FMT) yöntemini inceliyor. Doğrulanmış, tedaviye dirençli/nükseden CDI olan hastalar dahil edilir. Faz 1 aşamasında yürütülmekte olup davetle katılım alınmaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Davetle katılım

Sponsor

Baylor College of Medicine

Müdahale

Microbiota Transplantation (FMT)

Başlangıç

28.02.2013

Tahmini bitiş

28.02.2036

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

Only VA patients will be eligible for the study if they have had a confirmed diagnosis of CDI that has been treated for 10-14 days with recommended doses of metronidazole or vancomycin and has either failed to respond, or has responded and relapsed within 4 weeks of the end of treatment. The diagnosis will be regarded as confirmed by the presence of diarrhea (\>3 unformed stools in a 24-hour period for 2 successive days) and abdominal discomfort. The presence of fever, leukocytosis, and a serum albumin \<3 gm/dL will be recorded but will not be necessary for the diagnosis. Patients will be included after they have given informed consent and signed the appropriate consent form that has been approved by the Baylor IRB.

Exclusion Criteria:

Exclusion criteria include: treatment with major immunosuppressive agents including prednisone \>10 mg/day (or its equivalent), calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, lymphocyte-depleting biological agents, anti-tumor necrosis factor agents, and others; chemotherapeutic antineoplastic agents; decompensated liver cirrhosis; serum creatinine \>4 or need for hemodialysis; presence of an active malignancy other than superifical skin cancer (eg, basal cell); HIV/acquired immune deficiency syndrome; recent bone marrow transplant, or other cause of severe immunodeficiency; requirement for concurrent antimicrobial therapy; contraindication for ultra-slim endoscopy including severe chronic heart or lung disease; a chronic bedridden state; and any other condition suggesting that life span will not be \>1 yr.

\-