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| ID | Type | Description | Link |
|---|---|---|---|
| 14GA012 | Other Identifier | Nottingham University Hospitals NHS Trust |
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| Name | Class |
|---|---|
| Nottingham University Hospitals NHS Trust | OTHER |
| King's College London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal FODMAP arm | Sham Comparator | Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet. |
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| Low FODMAP arm | Experimental | Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low FODMAP dietary advice | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate or substantial improvement in IBS symptoms | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in EQ-5D-5L score | The EQ5D is a validated questionnaire to measure quality of life | 1 month after start of diet |
| Change from baseline in EQ-5D-5L score | 6 months after start of diet |
Inclusion Criteria:
Exclusion Criteria:
As for CERAMIC study (so already confirmed)
Addition criteria for CEDRIC study:
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| Name | Affiliation | Role |
|---|---|---|
| Giles AD Major, BM BCh MRCP | University of Nottingham | Principal Investigator |
| Robin C Spiller, PhD FRCP | University of Nottingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Nottingham | NG7 2UH | United Kingdom |
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| Label | URL |
|---|---|
| Departmental website | View source |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| C120489 | oligofructose |
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| Maltodextrin | Dietary Supplement | Dietary supplementation with maltodextrin 5 grams twice daily for a month |
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| Oligofructose | Dietary Supplement | Dietary supplementation with oligofructose 5 grams twice daily for a month |
|
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| 6 months after star of diet |
| Adequate control of IBS symptoms | Response to a yes/no question "Have your symptoms been adequately controlled?" | 1 month after start of diet |
| Adequate control of IBS symptoms | Response to a yes/no question "Have your symptoms been adequately controlled?" | 6 months after start of diet |
| Percentage of days with loose stool | Percentage of days with at least one stool of consistency type 6 or 7 on the Bristol stool form scale | during last 14 days of dietary intervention |
| Change from baseline in IBSS | The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders | 1 month after start of diet |
| Change from baseline in IBSS | 6 months after start of diet |
| Change from baseline in fasting colonic volume | This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention. | 1 month after start of diet |
| Change in fasting colonic gas volume | This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention. | 1 month after start of diet |
| Change from baseline in stool concentration of Bifidobacteria | This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention | 1 month after start of diet |
| Change from baseline in stool concentration of Bifidobacteria | This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention | 6 months after start of diet |
| Change from baseline in stool concentration of short-chain fatty acids | 1 month after start of diet |
| Change from baseline in stool concentration of short-chain fatty acids | 6 months after start of diet |
| Change from baseline in other clades of stool microbiota | This will be exploratory work to assess the effect of the diet on other constituents of the stool microbiota | 1 month after start of diet |
| Change from baseline in other clades of stool microbiota | 6 months after start of diet |