Clinical trial NCT02232373: Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-infective Bowel Dysfunction
Functional Gastrointestinal Disorders
Keywords: FODMAPs
microbiota
oligofructose
IBS
Irritable bowel syndrome
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: King's College London
First posted: 2014-09-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS
timeFrame: 1 month after start of diet
Secondary outcomes:
measure: Moderate or substantial improvement in IBS symptoms
timeFrame: 6 months after star of diet
measure: Adequate control of IBS symptoms
timeFrame: 1 month after start of diet
measure: Adequate control of IBS symptoms
timeFrame: 6 months after start of diet
measure: Percentage of days with loose stool
timeFrame: during last 14 days of dietary intervention
measure: Change from baseline in IBSS
timeFrame: 1 month after start of diet
measure: Change from baseline in IBSS
timeFrame: 6 months after start of diet
measure: Change from baseline in fasting colonic volume
timeFrame: 1 month after start of diet
measure: Change in fasting colonic gas volume
timeFrame: 1 month after start of diet
measure: Change from baseline in stool concentration of Bifidobacteria
timeFrame: 1 month after start of diet
measure: Change from baseline in stool concentration of Bifidobacteria
timeFrame: 6 months after start of diet
Other outcomes:
measure: Change from baseline in EQ-5D-5L score
timeFrame: 1 month after start of diet
measure: Change from baseline in EQ-5D-5L score
timeFrame: 6 months after start of diet
measure: Change from baseline in stool concentration of short-chain fatty acids
timeFrame: 1 month after start of diet
measure: Change from baseline in stool concentration of short-chain fatty acids
timeFrame: 6 months after start of diet
measure: Change from baseline in other clades of stool microbiota
timeFrame: 1 month after start of diet
measure: Change from baseline in other clades of stool microbiota
timeFrame: 6 months after start of diet
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Giles AD Major, BM BCh MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Robin C Spiller, PhD FRCP
role: STUDY_CHAIR
References: