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Table 3 Exclusion criteria for the donor

From: Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

1 Exclusion criteria related to general safety

Personal status

 

General

➢ Presence of chronic disease

➢ Pregnant or lactating women

➢ Adults under guardianship, safeguard justice, or trusteeship

➢ For donors over the age of 50 years, absence of screening test for colorectal cancer within 2 years and positive test result

Digestive

➢ Celiac disease

➢ Irritable bowel syndrome

➢ Chronic constipation

➢ Diarrhea defined as > 3 very soft or liquid stools per day

➢ Hemorrhoids or rectal bleeding

➢ Personal history of:

• gastrointestinal neoplasia or polyps

• autoimmune or inflammatory disease

• IBD

Diet and drug use

➢ Particular diet (exclusion diet, vegetarian diet) or other specific considerations: ingestion of a potential allergen (e.g. peanut) to which the recipient has a known allergy

➢  → Alcohol or drug abuse

➢ Spouse of a patient with IBD

Family status

➢ First-degree family history of:

• IBD

• gastrointestinal neoplasia or polyps before the age of 60 years

• autoimmune or inflammatory disease

➢ Diarrhea defined as > 3 very soft or liquid stools per day for the family members within 3 months.

2 Exclusion criteria related to prior or concomitant treatment

 

➢ No medication whatsoever in the 48 h before the donation (except contraceptive treatment)

➢ No regular curative medication except oral contraception

➢ Immunosuppressants (e.g. calcineurin inhibitors, corticosteroids, biological agents, etc.) antineoplastic chemotherapy

➢ Antibiotic or antifungal in the previous 3 months before the donation

➢ Non-steroidal anti-inflammatory intake in the previous month for the donation

3 Exclusion criteria related to infection risk

General

➢ Abnormal macroscopic appearance of stool

➢ Known infection by HIV, HTLV virus, hepatitis B or C virus

➢ Positive result in one of the contagious disease testing (see Appendix ANSM)

➢ Existence of anal lesions suggestive of viral infection (papillomas, vesicles, or other lesions)

➢ Multiresistant bacteria carrier (see Appendix ANSM)

➢ Risk of Creutzfeldt–Jakob disease

➢ Personal history of typhoid fever

2 years

➢ Residence in the intertropical zone > 2 years

12 months

➢ Hospitalization abroad > 24 h in the last 12 months (including members of the family)

6 months

➢ Contact with human blood (blood transfusion, piercing, tattoo, etc.) within the previous 6 months

➢ Sexual behavior risk (defined as unprotected sexual contact with a new partner) in the previous 6 months

3 months

➢ Gastroenteritis in the last 3 months

Digestive disorders such as acute or chronic diarrhea in the 3 months preceding the donation

➢ Behavior deemed at risk of infection: travel in the previous 3 months

14 days

➢ Infectious episode 14 days before screening

Blood tests

Biology

➢ Abnormal local lab value concerning the following tests: fasting glucose, blood count, platelets, ferritin, CRP, ionogram, urea, creatinine, AST/ALT, gamma glutamyl transferase, alkaline phosphatase, bilirubin, prothrombin time, activated partial thromboplastin time, lipids (cholesterol, triglycerides)

Virology, bacteriology, and parasitology

See Table 2

Stool test

Virology, bacteriology, and parasitology

See Table 2

  1. CRP C-reactive protein, HIV human immunodeficiency virus; IBD Irritable Bowel Syndrome