Condition category
Digestive System
Date applied
13/02/2014
Date assigned
26/02/2014
Last edited
04/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Irritable Bowel Syndrome (IBS) is a chronic and debilitating functional disorder of the gastrointestinal tract with serious and detrimental impacts on quality of life. What causes it is largely unknown and there are no effective treatments. This study will investigate whether a vitamin-D deficient subpopulation would respond to supplementation versus either placebo or replete controls, and whether probiotics and vitamin D would have additive benefits. A recent study found that high-dose vitamin D supplementation may lead to remission of symptoms at least in a subset of individuals with IBS. There are no data upon which to base a power calculation and the purpose of this study is to to establish such information.

Who can participate?
Subjects with moderate or severe IBS, generally in the Sheffield area of willing to travel to take part.

What does the study involve?
Participants will have an initial screening of symptoms and a blood test to assess vitamin D levels, then they will consume a nasal spray (vitamin D or placebo) and a capsule (probiotics or placebo) for 8 weeks. Participants will report symptom questionnaires across the course of the study and at the end will have a second blood sample measured. Some participants may choose to join a focus group after exit to explore attitudes and outcomes.

What are the possible benefits and risks of participating?
No direct benefits, athough participants will be informed of their vitamin D status and will receive advice is this is low. If participants already have high levels of vitamin D, they would risk excess levels and would therefore be excluded from participating.

Where is the study run from?
University of Sheffield (UK).

When is the study starting and how long is it expected to run for?
The study starts in January 2014 and is expected to run for around 8 months, with analysis of data taking sometime longer.

Who is funding the study?
Cultech Ltd.

Who is the main contact?
Dr Bernard Corfe

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bernard Corfe

ORCID ID

Contact details

Department of Oncology
University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v2

Study information

Scientific title

Randomised Controlled Pilot Trial: Does vitamin D alone, or in combination with probiotics improve symptoms of IBS (PROBIVIT)?

Acronym

PROBIVIT

Study hypothesis

1. Vitamin D supplementation will improve symptoms in irritable bowel syndrome (IBS) patients with a vitamin D deficiency.
2. IBS patients will have low circulating levels of vitamin D and this will be due to either dietary deficiency or malabsorption.
3. Benefits of vitamin D supplementation will be further improved by combination with probiotics.

Ethics approval

Not provided at time of registration

Study design

2 x 3 fractional factorial design with stratification by vitamin D status

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Irritable Bowel Syndrome

Intervention

After stratification, participants will be randomised into one of three groups:
1. 3000IU vitamin D spray plus placebo for probiotic (maltodextrin)
2. 3000IU vitamin D spray plus Lab4 probiotic ( 25 billion cfu/capsule)
3. Placebo spray plus placebo for probiotic

Total duration of treatment and follow-up : 8 weeks

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D, probiotic

Primary outcome measures

Reduction in Total Symptom Severity for IBS, measured by VAS at week 8, and a cumulative measure taken fortnightly across the intervention period (weeks 0, 2, 4, 6 + 8)

Secondary outcome measures

1. Reduction in composite symptom severity, measured by VAS at week 8, and a cumulative measure taken fortnightly across the intervention period (weeks 0, 2, 4, 6 + 8)
2. Change in vitamin D status, measured in serum at baseline and week 8

Overall trial start date

01/01/2014

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18-65 years old
2. Diagnosed with IBS
3. Moderate-severe symptom severity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Any antibiotic use in the past 4 weeks (likely to modify gut flora)
2. Any changes in IBS medication/therapies in the last 4 weeks (may affect IBS symptoms which would influence the results of the trial)
3. Pregnant or lactating females
4. Regular use of vitamin/probiotic supplements (again may influence trial results)
5. Any previous GI surgery, GI cancers or inflammatory bowel disease
6. Diabetes mellitus
7. Current use of antidepressants
8. Current or previous use of antipsychotics

Recruitment start date

01/01/2014

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S10 2RX
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Western Bank
Sheffield
S10 2TN
United Kingdom

Sponsor type

University/education

Website

http://www.shef.ac.uk

Funders

Funder type

Industry

Funder name

Cultech Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26719813

Publication citations

Additional files

Editorial Notes