Measuring the impact of dietary supplementation with prebiotics on markers of inflammation in ulcerative colitis

Not Applicable

Completed

• Conditions: lcerative Colitis; Digestive System; Ulcerative Colitis

• Registration Number: ISRCTN26720438
• Lead Sponsor: King's College London

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-16
• Study Completion: 2018-03-30
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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
8. Individuals able to give informed consent
9. Individuals willing to participate

Exclusion Criteria

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
2.2. Use of prebiotics or probiotics (in other food products or as supplements) four weeks prior to starting intervention
2.3. Bowel preparation for a diagnostic procedure e.g. colonoscopy four weeks prior to starting intervention
2.4. Regular use of other supplements/medications that may affect the luminal microenvironment of the intestine (e.g. Orlistat, Lactulose)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of genes involved in immunity and inflammation in peripheral blood is measured using mRNA microarray to identify target genes and qPCR to quantify changes in gene expression, at baseline and 6 weeks.