CEDRIC: Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

Sponsor

University of Nottingham (Other)

Overall Status

Terminated

CT.gov ID

NCT02232373

Collaborator

Nottingham University Hospitals NHS Trust (Other), King's College London (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-infective Bowel Dysfunction Functional Gastrointestinal Disorders	Behavioral: low FODMAP dietary advice Dietary Supplement: Maltodextrin Dietary Supplement: Oligofructose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Normal FODMAP arm 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 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 Supplement: Oligofructose Dietary supplementation with oligofructose 5 grams twice daily for a month Other Names: OraftiP95
Experimental: Low FODMAP arm Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)	Behavioral: low 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 Supplement: Maltodextrin Dietary supplementation with maltodextrin 5 grams twice daily for a month

Arm

Intervention/Treatment

Sham Comparator: Normal FODMAP arm

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

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 Supplement: Oligofructose

Dietary supplementation with oligofructose 5 grams twice daily for a month

Other Names:

OraftiP95

Experimental: Low FODMAP arm

Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)

Behavioral: low 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 Supplement: Maltodextrin

Dietary supplementation with maltodextrin 5 grams twice daily for a month

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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?"
Adequate control of IBS symptoms [6 months after start of diet]
Response to a yes/no question "Have your symptoms been adequately controlled?"
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 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
Change from baseline in IBSS [6 months after start of diet]
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
Change from baseline in stool concentration of Bifidobacteria [6 months after start of diet]
This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention

Other Outcome Measures

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 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]
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 [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 other clades of stool microbiota [6 months after start of diet]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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