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
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 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
01/01/2014
Overall trial end date
31/08/2014
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26719813