A research study looking at faecal transplant as a treatment for ulcerative colitis, and the best way to use it in children and adults with the conditio

Phase 1

• Conditions: lcerative colitis for at least 3 months prior to trial entry; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-005753-12-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-02
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Donors:
1)Over 18 and under 50 years of age
2)regular morning bowel habits, which can be classified as Bristol stool chart type 2-5
3)normal BMI (over 18.5 and under 25)
4) presently be non-smokers (not smoked for the past 12 months)
5) provide written informed consent

Patients:
1)Confirmed UC for at least 3 months from date of screening
2) Age 12-70 years
3) Partial Mayo score of between 4 and 8 despite stable 5ASA+/- thiopurine, methotrexate or no treatment
4) Rectal bleeding subscore >0
5) Written, signed informed consent and/or assent to the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Donors:
GI history of:
-inflammatory bowel disease
-irritable bowel syndrome, idiopathic chronic constipation or chronic diarrhoea
-gastrointestinal malignancy or known polyposis
-celiac disease
-congenital or chronic liver disease
-per rectal bleeding
-major gastrointestinal surgery (eg gastric bypass)

AUTOIMMUNE history of systemic autoimmunity including:
-Connective tissue disease
-Thyroid disease
-Inflammatory arthritis
-Psoriasis
-Alopecia

ATOPIC disease inc.
-Asthma
-Atopic dermatitis
-Eczema
-Eosinophilic disorders of the gastrointestinal tract

CHRONIC PAIN history inc.
-Chronic fatigue syndrome
-Fibromyalgia

CARDIOVASCULAR history of a cardiovascular or metabolic syndrome including:
-Diabetes (type 1 or type 2)
-High blood pressure
-High cholesterol
-High fasting glucose
-Heart disease (eg atherosclerosis, myocardial infarction, congestive heart failure)

NEUROLOGICAL history of neurological conditions including:
-Multiple Sclerosis
-Parkinson’s disease
-Alzheimer’s disease or dementia disorders

IMMUNOSUPPRESSION history of any major immunosuppressive mechanisms including:
-Calcineurin inhibitors
-Exogenous glucocorticoids
-Biological agents
-Anti-TNF factors
-Systemic chemotherapeutic anti-neoplastic agents
-Transplantation (eg solid organ, bone marrow, cornea etc)

MENTAL HEALTH AND WELL BEING history of having been diagnosed by a clinician with any of the following:
-Depression
-Bipolar disorder
-Schizophrenia or delusional disorder
-Eating disorder (eg anorexia and / or bulimia)

INFECTIOUS DISEASES
-Known to have HIV, HBV and/or HCV infection
-Known to have been exposed to HIV, HBV and/or HCV in the preceding 12 months
-Risk of Creutzfeldt-Jakob disease (CJD) or variant CJD
-Originate from or share sexual partners or have a parent who originates from areas with high-incidence Human T-cell Lymphotropic Virus eg Caribbean, Japan, South America and Africa.
-Positive microbiology testing for any of the pathogens described donor testing schedule

HIGH RISK ACTIVITIES FOR BLOODBORNE INFECTIONS
Engaged in any known high risk activities for blood-borne infections, including:
-Sexual contact with an individual with known or suspected HIV, AIDS and/or hepatitis
-Sexual contact with a man who has had sex with another man
-Sex for drugs or money (both receiving and/or paying)
-Use of illicit drugs including IV, oral or inhaled
-Tattoo or body piercing in the preceding 6 months

MEDICATIONS, PROBIOICS AND VACCINATIONS
-History of proton pump inhibitor use
-History of antibiotics within the preceding 3 months
-History of receiving growth hormone, insulin from cows or cloting factor concentrates
-History of receiving an experimental medicine or experimental vaccine
-History of VSL3 probiotic food supplement or Mutaflor probiotic use
-History of receiving a live vaccination within the preceding one month

DIETARY, SOCIAL AND TRAVEL HISTORY
-Participation in a strict vegan diet
-Work or volunteering activities in which the donor comes into contact with animal or human tissues
-Any previous tobacco use
-Travelled outside Europe, North America or Australasia in the preceding 3 months

FAMILY HISTORY
-History of a first degree relative diagnosed with colon cancer under the age of 55
-History of a first degree relative having inflammatory bowel disease

The following are exclusion criteria which if highlighted in the donor health questionnaire must be explored in detail with the d

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified