Does vitamin D alone, or in combination with probiotics improve symptoms of irritable bowel syndrome (IBS) (PROBIVIT)?

ISRCTN ISRCTN75474149
DOI https://doi.org/10.1186/ISRCTN75474149
Secondary identifying numbers v2
Submission date
13/02/2014
Registration date
26/02/2014
Last edited
04/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Bernard Corfe
Scientific

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

Study information

Study design2 x 3 fractional factorial design with stratification by vitamin D status
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised Controlled Pilot Trial: Does vitamin D alone, or in combination with probiotics improve symptoms of IBS (PROBIVIT)?
Study acronymPROBIVIT
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedIrritable Bowel Syndrome
InterventionAfter 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 typeSupplement
Primary outcome measureReduction 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 measures1. 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 study start date01/01/2014
Completion date31/08/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants150
Key inclusion criteria1. 18-65 years old
2. Diagnosed with IBS
3. Moderate-severe symptom severity
Key exclusion criteria1. 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
Date of first enrolment01/01/2014
Date of final enrolment31/08/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Sheffield
Sheffield
S10 2RX
United Kingdom

Sponsor information

University of Sheffield (UK)
University/education

Western Bank
Sheffield
S10 2TN
England
United Kingdom

Website http://www.shef.ac.uk
ROR logo "ROR" https://ror.org/05krs5044

Funders

Funder type

Industry

Cultech Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/12/2015 Yes No