The effect of six-weeks dietary supplementation with prebiotics (Trans-galactooligosaccharide (B-GOS) on the expression of genes involved in immunity and inflammation in peripheral blood of adult participants with mildly active ulcerative colitis in an open label pilot study

King's College London0 sites18 target enrollmentNovember 16, 2016

Overview

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34684597/ (added 10/08/2022)

Registry

who.int

Start Date

November 16, 2016

End Date

March 30, 2018

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Men and women aged 16\-65 years
•2\. Women who are not currently pregnant or lactating
•3\. Mildly active UC defined by Gastroenterologist’s opinion and supported one or more of
•3\.1\. CRP above normal for referring centre
•3\.2\. Faecal calprotectin greater than 150 ug/g
•3\.3\. Recent endoscopic evidence of active disease
•4\. No anticipated changes to dose or type of UC medication for the seven week trial period
•5\. Patients without another major medical condition (e.g. diabetes, psychiatric or current eating disorders), other gastrointestinal disease or condition (e.g. Crohn’s disease, coeliac disease, lactose or dairy allergy), known enteropathogen or history of previous major GI surgery, except cholecystectomy, appendectomy and haemorrhoidectomy
•6\. Participants who have not received bowel preparation for investigative procedures in the four weeks prior to the study
•7\. Participants who have not taken antibiotics, prebiotics or probiotics (in other food products or as supplements) in the four weeks prior to, or during the study

•1\. Factors affecting immunity and inflammation
•1\.1\. Started azathioprine, mercaptopurine or thioguanine therapy less than 12 weeks previously or who have changed dose in the previous 6 weeks
•1\.2\. Started 5\-asa (mesalazine) therapy less than 8 weeks previously or who have changed dose in the previous 2 weeks
•1\.3\. Prescribed use of steroids
•1\.4\. Prescribed use of methotrexate
•1\.5\. Prescribed use of the immunosuppressant drugs ciclosporin and tacrolimus
•1\.6\. Prescribed use of anti\-inflammatory drugs e.g. infliximab, vedoluzimab, golimumab, adolimubab
•1\.7\. Regular use of non\-steroidal anti\-inflammatory drugs (NSAIDs)
•2\. Factors which may confound impact of prebiotic supplementation
•2\.1\. Use of antibiotics four weeks prior to starting intervention