Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Double Blind, Randomised, Placebo Controlled Trial of the Effect of a Diet Low in Poorly Digested Carbohydrates on Symptoms of Post-infective Bowel Dysfunction

Conditions
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Post-infective Bowel Dysfunction, Functional Gastrointestinal Disorders

Intervention / Treatment
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* Behavioral: low FODMAP dietary advice
* Dietary Supplement: Maltodextrin
* Dietary Supplement: Oligofructose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in the CERAMIC study (see linked protocol) On-going post infective bowel dysfunction (PI-BD) 3 months after confirmation of Campylobacter spp. in stool sample. This is defined as responding 'No' to the question have your bowels returned to normal since your Campylobacter infection? Will consent to use of data and samples acquired for CERAMIC in the analysis of CEDRIC Exclusion Criteria: As for CERAMIC study (so already confirmed) Pregnancy declared by the candidate History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to: Inflammatory Bowel Disease; Coeliac Disease; Pancreatitis; Gallstone disease (biliary colic, cholecystitis); Diverticulitis; Cancer of the gastrointestinal tract; Irritable Bowel Syndrome Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder Intestinal stoma Habitual use of opiate analgesics likely to alter bowel function e.g. morphine Use of antibiotics in the preceding four weeks other than for treatment of index infection. Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration Inability to complete the symptom questionnaires e.g. cognitive dysfunction, limiting memory and understanding Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse Addition criteria for CEDRIC study: Use of antibiotics or prescribed probiotics during the CERAMIC study Failure to provide research stool samples during CERAMIC study Dietary practice not compatible with safe implementation of the trial diet e.g.veganism Medical reasons for pre-existing controlled diet that cannot be safely randomised e.g. end-stage kidney disease, diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Normal FODMAP arm<br>Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet. | Behavioral: low FODMAP dietary advice<br>* 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.<br>Dietary Supplement: Oligofructose<br>* Dietary supplementation with oligofructose 5 grams twice daily for a month<br>* Other names: OraftiP95;|
| Experimental: Low FODMAP arm<br>Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate) | Behavioral: low FODMAP dietary advice<br>* 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.<br>Dietary Supplement: Maltodextrin<br>* Dietary supplementation with maltodextrin 5 grams twice daily for a month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FODMAPs, microbiota, oligofructose, IBS, Irritable bowel syndrome