ID

45267

Descrição

Principal Investigator: Vincent Young, MD PhD, University of Michigan, Ann Arbor, MI, USA MeSH: Pouchitis,Inflammatory Bowel Diseases,Colitis, Ulcerative https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000262 The aims of the multi-center Ulcerative Colitis Human Microbiome Project (UCHMP) are to examine the role of the enteric microbiome in causing human ulcerative colitis, specifically the development of pouchitis. Pouchitis is an inflammatory condition of the surgically-created ileoanal pouch that serves as a pseudo-rectum in patients with ulcerative colitis who have undergone a total colectomy. It is a condition unique to ulcerative colitis (UC), as it rarely occurs in non-UC patients who have the same procedure. Within one year, about 50% of patients will develop pouchitis. The condition is almost certainly due to aspects of the pouch microbiota on a background of genetic susceptibility, as most patients respond to treatment with antibiotics. While there have been reports on the microbiota in pouchitis patients, all have been performed after the inflammatory process is initiated, rendering interpretation of the results difficult, as the inflammatory process itself will change the microbiota. *Our project is therefore unique and possibly the only opportunity in the role of the enteric microbiome in IBD in a prospective manner, thereby establishing potentially important causal relationships between microbiota structure or function and development of UC.*The studies also offer two additional advantages. First, the development of the pouch microbiota can be observed prospectively. Second, the cause of antibiotic treatment failure in some patients with pouchitis may be revealed. The two aims are (1) to identify causal factors in the structure and/or function of the enteric microbiota in the development of pouchitis, and (2) to determine the basis of treatment failure in UC pouchitis patients. Our analyses will include serial measurements of enteric microbial structure (16S rRNA gene-based), function (metagenomics and functional candidate genes), and cultivation, the latter to enhance interpretation of gene sequences derived from metagenomes and targeted gene surveys (either functional or 16S genes). The insights gained from these studies will help us understand the fundamental and causative roles of the enteric microbiome in human inflammatory bowel diseases (IBD). This information will be the basis for developing strategies to restore host-microbial relationships to prevent and treat IBD.

Link

dbGaP study = phs000262

Palavras-chave

  1. 07/06/2022 07/06/2022 - Dr. Christian Niklas
  2. 12/10/2022 12/10/2022 - Adrian Schulz
Titular dos direitos

Vincent Young, MD PhD

Transferido a

12 de outubro de 2022

DOI

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Licença

Creative Commons BY 4.0

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dbGaP phs000262 The Role of the Gut Microbiota in Ulcerative Colitis

Eligibility Criteria

Inclusion and exclusion criteria
Descrição

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Inclusion Criteria:*
Descrição

Elig.phs000262.v3.p2.1

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1512693
Age greater than or equal to 18 years
Descrição

Elig.phs000262.v3.p2.2

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0001779
Confirmed diagnosis of ulcerative colitis
Descrição

Elig.phs000262.v3.p2.3

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0009324
Subject scheduled for a total proctocolectomy with ileal pouch anal anastomosis
Descrição

Elig.phs000262.v3.p2.4

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0842176
UMLS CUI [1,2]
C0332853
UMLS CUI [1,3]
C0020885
UMLS CUI [1,4]
C0003461
The patient is willing and able to sign the written, informed consent document
Descrição

Elig.phs000262.v3.p2.5

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0021430
*Exclusion Criteria:*
Descrição

Elig.phs000262.v3.p2.6

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0680251
Female patients who are pregnant
Descrição

Elig.phs000262.v3.p2.7

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0032961
The patient appears to be uncooperative or not dependable for any reason
Descrição

Elig.phs000262.v3.p2.8

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0424350
Patients unable to give informed consent
Descrição

Elig.phs000262.v3.p2.9

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Criteria

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Item
*Inclusion Criteria:*
text
C1512693 (UMLS CUI [1,1])
Code List
*Inclusion Criteria:*
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
Age greater than or equal to 18 years
text
C0001779 (UMLS CUI [1,1])
Code List
Age greater than or equal to 18 years
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
Confirmed diagnosis of ulcerative colitis
text
C0011900 (UMLS CUI [1,1])
C0009324 (UMLS CUI [1,2])
Code List
Confirmed diagnosis of ulcerative colitis
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
Subject scheduled for a total proctocolectomy with ileal pouch anal anastomosis
text
C0842176 (UMLS CUI [1,1])
C0332853 (UMLS CUI [1,2])
C0020885 (UMLS CUI [1,3])
C0003461 (UMLS CUI [1,4])
Code List
Subject scheduled for a total proctocolectomy with ileal pouch anal anastomosis
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
The patient is willing and able to sign the written, informed consent document
text
C0021430 (UMLS CUI [1,1])
Code List
The patient is willing and able to sign the written, informed consent document
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
*Exclusion Criteria:*
text
C0680251 (UMLS CUI [1,1])
Code List
*Exclusion Criteria:*
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
Female patients who are pregnant
text
C0032961 (UMLS CUI [1,1])
Code List
Female patients who are pregnant
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
The patient appears to be uncooperative or not dependable for any reason
text
C0424350 (UMLS CUI [1,1])
Code List
The patient appears to be uncooperative or not dependable for any reason
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)
Item
Patients unable to give informed consent
text
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Code List
Patients unable to give informed consent
CL Item
No (0)
CL Item
Yes (1)
CL Item
No answer (2)

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