Intervention: Torbugesic
Trial phase: Phase 1
SMILES: O=C(O)C(O)C(O)C(=O)O.Oc1ccc2c(c1)C13CCCCC1(O)C(C2)N(CC1CCC1)CC3
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
Eligibility criteria:
Participant Inclusion Criteria:

Children ages >7 and ≤21 years of age with established diagnosis of Inflammatory Bowel Disease (IBD) colitis (patient with ulcerative colitis (UC) or patients with crohn's disease (CD) with colonic involvement only)
Have clinical disease (mild to moderate disease: 10≤ Pediatric Ulcerative Colitis Activity Index (PUCAI) <65)
Have stable disease activity and therapy for two months prior to Gut Microbial Transplantation (GMT) procedure.

Participant Exclusion Criteria:

Fulminant colitis
Indication or scheduled for surgery
Pregnancy
Use of probiotic supplements during the study period (subjects who have stopped use of probiotic supplements will be eligible as long as they stop taking it 2 weeks prior to Day 1 of GMT)
anemia (hemoglobin < 6.0 g/dL) in last one month
Graft versus host disease (GVHD)

Severely immunocompromised - defined as

History of opportunistic infection (tuberculosis, Pneumocystis jirovecii or systemic fungal infections) in last one year or
Neutropenia: Absolute neutrophil count (ANC) <500
Major intra-abdominal surgery within 90 days prior to Day 1 of GMT
Administration of any investigational drug within 30 days prior to Day 1 of GMT.
Have received infliximab or other tumor necrosis factor (TNF) inhibitors within 2 months prior to Day 1 of GMT or are expected to receive such therapy within 1 month post final GMT.

Donor Inclusion Criteria

Based on patient's and parents'/guardian's decision
Will be chosen from immediate adult (≥18 years) family members or close friends
Should have negative or normal results on screening tests (as explained in donor exclusion criteria below)

Donor Exclusion Criteria (adopted from guidelines provided by American Association of Blood Bank Donor History Questionnaire and American Gastroenterological Association)

Positive or abnormal screening test to include:

Hepatitis A Immunoglobulin M (IgM) antibody
Hepatitis B antibody panel suggestive of infection (HBc IgM, HBs Ag, HBs Ab)
Hepatitis C antibody Level
Cytomegalovirus (CMV) IgM antibody
Ebstein Barr Virus (EBV) viral capsid antigen (VCA) IgM antibody
Syphilis Immunoglobulin G (IgG) Ab Screen
Human Immune Deficiency Virus (HIV) I & II enzyme-linked immunosorbent assay (ELISA) screen
Stool i) Fungal smear ii) Stool cultures to exclude Salmonella, Shigella, Escherichia Coli, Campylobacter, Yersinia, Vibrio, Listeria iii) Clostridium difficile toxin assay iv) Ova and parasite screen for Giardia and Cryptosporidium
History of metabolic syndrome or gastric bypass surgery
History of GI conditions: IBD, irritable bowel syndrome, chronic abdominal pain, GI Malignancy, blood in stool or diarrhea in the last 4 weeks before enrollment
Antibiotic or probiotic use within 3 months before enrollment and for the duration of the donation

Positive response on screening questionnaire to any of the following:

History of active malignancy or any cancer within the last 5 years (excluding basal cell carcinoma of the skin)
Family history of Creutzfeld-Jacob disease
Corneal or dural transplant
History of high risk sexual behavior (e.g. sexual contact with HIV/acquired immune deficiency syndrome (AIDS) positive, hepatitis positive partner, men who have sex with men, sex for drugs or money)
History of signs of sexually transmitted infections such as genital ulcerations, anogenital herpes, anogenital warts, cancroids or syphilitic lesions
Use of illicit drugs
Travel within the last 6 months to areas of the world where diarrheal illnesses are endemic
History or signs of immunosuppression i) History of any immunosuppressant medication(s) within the last 6 months or history of opportunistic infection(s) in past 1 year ii) Signs of immunosuppression such as:
Oral thrush
Disseminated lymphadenopathy