Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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



Primary contact

Dr Bernard Corfe


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

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


Irritable Bowel Syndrome


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



Not Applicable

Drug names

Vitamin D, probiotic

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
S10 2RX
United Kingdom

Sponsor information


University of Sheffield (UK)

Sponsor details

Western Bank
S10 2TN
United Kingdom

Sponsor type




Funder type


Funder name

Cultech Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2015 results in:

Publication citations

Additional files

Editorial Notes