Sponsor study identifier
Secondary identifiers
OTHER · Nottingham University Hospitals NHS Trust
interventional
9
1 country
1
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)The purpose of the study is explore the issues that relate to testing a particular dietary treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with which to compare it. In this trial the investigators will look at its effect on symptoms of people with persistent disturbance in their bowel pattern 3 months after an intestinal infection with Campylobacter. The investigators will also look at the changes in gut bacteria that occur with the diet.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 2, 2014
Actual (reported)September 5, 2014
Actual (reported)August 2015
Actual (reported)August 2015
Actual (reported)Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS
The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.
1 month after start of diet
Moderate or substantial improvement in IBS symptoms
6 months after star of diet
Adequate control of IBS symptoms
1 month after start of diet
Adequate control of IBS symptoms
6 months after start of diet
Percentage of days with loose stool
during last 14 days of dietary intervention
Change from baseline in IBSS
1 month after start of diet
Change from baseline in EQ-5D-5L score
1 month after start of diet
Change from baseline in EQ-5D-5L score
6 months after start of diet
Change from baseline in stool concentration of short-chain fatty acids
1 month after start of diet
Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet.
Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)
An education session with a specialist dietitian, and provision of written advice, on how to follow the low FODMAP diet. Second session after one month on re-introduction of FODMAP containing foods.
Dietary supplementation with maltodextrin 5 grams twice daily for a month
University of Nottingham
Nottingham, NG7 2UH, United Kingdom
Giles AD Major, BM BCh MRCP
University of Nottingham
Robin C Spiller, PhD FRCP
University of Nottingham
9 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2014
First Posted
September 5, 2014
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms
Dietary supplementation with oligofructose 5 grams twice daily for a month
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Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
May 13, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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