Functional Gastrointestinal Disorders, Post-infective Bowel Dysfunction
Conditions
Keywords
FODMAPs, microbiota, oligofructose, IBS, Irritable bowel syndrome
Brief summary
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.
Interventions
BEHAVIORALlow FODMAP dietary advice
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_SUPPLEMENTMaltodextrin
Dietary supplementation with maltodextrin 5 grams twice daily for a month
DIETARY_SUPPLEMENTOligofructose
Dietary supplementation with oligofructose 5 grams twice daily for a month
Sponsors
Nottingham University Hospitals NHS Trust
King's College London
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS | 1 month after start of diet | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of days with loose stool | during last 14 days of dietary intervention | Percentage of days with at least one stool of consistency type 6 or 7 on the Bristol stool form scale |
| Change from baseline in fasting colonic volume | 1 month after start of diet | This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention. |
| Change in fasting colonic gas volume | 1 month after start of diet | This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention. |
| Change from baseline in stool concentration of Bifidobacteria | 1 month after start of diet | This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention |
| Moderate or substantial improvement in IBS symptoms | 6 months after star of diet | 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. |
| Adequate control of IBS symptoms | 1 month after start of diet | Response to a yes/no question Have your symptoms been adequately controlled? |
| Change from baseline in IBSS | 1 month after start of diet | The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in other clades of stool microbiota | 1 month after start of diet | This will be exploratory work to assess the effect of the diet on other constituents of the stool microbiota |
| Change from baseline in EQ-5D-5L score | 1 month after start of diet | The EQ5D is a validated questionnaire to measure quality of life |
| Change from baseline in stool concentration of short-chain fatty acids | 1 month after start of diet | — |
Countries
United Kingdom
Outcome results
None listed