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 |
| Protocol serial number | v2 |
| Sponsor | University of Sheffield (UK) |
| Funder | Cultech Ltd (UK) |
- 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
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
Scientific
Department of Oncology
University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | 2 x 3 fractional factorial design with stratification by vitamin D status |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised Controlled Pilot Trial: Does vitamin D alone, or in combination with probiotics improve symptoms of IBS (PROBIVIT)? |
| Study acronym | PROBIVIT |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
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) |
| Completion date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. 18-65 years old 2. Diagnosed with IBS 3. Moderate-severe symptom severity |
| Key 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 |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
S10 2RX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
