Condition category
Digestive System
Date applied
08/11/2016
Date assigned
16/11/2016
Last edited
15/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ulcerative colitis (UC) is a condition which cause long-term inflammation (swelling) in the colon and rectum (the last part of the large intestine). The exact cause is unknown, but some think that it may be because the immune system attacks the healthy tissue of the gut (autoimmune disease). There is currently no cure, and so the main aim of treatment is to reduce the symptoms (remission) and prevent the disease from “flaring up” and becoming active again. Even when the disease is in remission, many patients still experience symptoms such as bloating, diarrhoea and abdominal (tummy) pain. Studies looking at UC in people and in the lab have found that some types prebiotics (an ingredient in some foods which helps increase the amount of 'good' bacteria in the gut) may help reduce inflammation by signalling to the immune system through specific pathways. The way this works is unclear however and requires further research. The aim of this study is to find out whether consuming prebiotics daily has an effect on gut inflammation in people with UC.

Who can participate?
Men and women aged 16-65 who have ulcerative colitis.

What does the study involve?
All participants are provided with a six week supply of Bimuno prebiotic dietary supplement and are asked to take this daily for six weeks. Before starting and at the end of the trial participants are asked to fill in a food and bowel diary to tell the researchers about what their normal diet, gut symptoms and bowel habits are like in to have information to compare the results to. Participants provide blood, stool and urine samples at the start of the trial and after six weeks of taking the supplements to measure markers of immunity and inflammation.

What are the possible benefits and risks of participating?
Bimuno is a prebiotic widely available in the UK, participants will be provided with this for free for six weeks to supplement their normal diet. The main researcher is a qualified Dietitian and will be able to answer questions about diet and at the end of the study provide any dietary advice that may be relevant to the participant (not during the trial though as diet should stay the same). Their are no anticipated risks to taking part.

Where is the study run from?
1. Guy's Hospital, London (UK)
2. Royal London Hospital, London (UK)

When is the study starting and how long is it expected to run for?
May 2016 to March 2018

Who is funding the study?
1. Clasado Ltd (UK)
2. King's College London, Diabetes and Nutritional Sciences Division (UK)

Who is the main contact?
Miss Bridgette Wilson
bridgette.wilson@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Bridgette Wilson

ORCID ID

Contact details

King's College London
Office 4.103
150 Stamford Street
London
SE1 9NH
United Kingdom
+44 20 7848 4552
bridgette.wilson@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS ID: 208755

Study information

Scientific title

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

Acronym

Prebiotics in immunity and inflammation

Study hypothesis

This is an exploratory study to investigate the impact on markers of inflammation and immunity of dietary prebiotic supplementation in gastrointestinal inflammation. This study is intended to generate hypotheses for future research into dietary interventions for gut inflammation.

Ethics approval

Yorkshire and the Humber - Bradford Leeds Research Ethics Committee, 04/10/2016, ref: 16/YH/0438

Study design

Open label multi-centre non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Ulcerative Colitis

Intervention

All participants will be required to take one 5.5g sachet which contains 2.7g prebiotic food supplement (Bimuno, Clasado) daily for six weeks. This will be reconstituted with water and participants will be encouraged to take the sachet at the same time each day.

Participants provide blood, urine and stool samples for analysis at baseline and six weeks.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

All secondary outcome measures will be assessed at baseline before the intervention begins and at the end of six weeks, blood, stool and urine samples will be collected at these two timepoints in order to assess the following:
1. Serum or plasma protein expression will be assessed using enzyme linked immunosorbent assays (ELISA) and standard blood laboratory techniques
2. Faecal markers of inflammation such as faecal calprotectin and human beta-defensin 2 will be measured using ELISA
3. Metabolomic profiles in urine are measured using mass spectrometric based approaches in urine metabolomics
4. Gut microbiota metabolites indicators including proteases, SCFAs, and VOC will be measured using standard laboratory techniques including gas liquid chromatography
5. pH will be measured on fresh stool using a solid probe pH meter
6. Bacterial communities and function will be measured via sequencing techniques

Overall trial start date

01/05/2016

Overall trial end date

30/03/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18

Participant 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)

Recruitment start date

29/11/2016

Recruitment end date

30/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Hospital
Guy's and St Thomas' NHS Foundation Trust Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

The Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

1.8 Hodgkin Building
Guy's Campus
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Clasado Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

King's College London, Diabetes and Nutritional Sciences Division

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/10/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes