Does vitamin D alone, or in combination with probiotics improve symptoms of irritable bowel syndrome (IBS) (PROBIVIT)?
Not Applicable
Completed
- Conditions
- Irritable Bowel SyndromeDigestive System
- Registration Number
- ISRCTN75474149
- Lead Sponsor
- niversity of Sheffield (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. 18-65 years old
2. Diagnosed with IBS
3. Moderate-severe symptom severity
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)<br>2. Change in vitamin D status, measured in serum at baseline and week 8