Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

NCT ID: NCT02232373

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-08-31

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.

Conditions

Post-infective Bowel Dysfunction; Functional Gastrointestinal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

low FODMAP dietary advice

Intervention Type: 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.

Oligofructose

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplementation with oligofructose 5 grams twice daily for a month

Low FODMAP arm

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

Group Type: EXPERIMENTAL

low FODMAP dietary advice

Intervention Type: 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.

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplementation with maltodextrin 5 grams twice daily for a month

Interventions

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.

Intervention Type: BEHAVIORAL

Maltodextrin

Dietary supplementation with maltodextrin 5 grams twice daily for a month

Intervention Type: DIETARY_SUPPLEMENT

Oligofructose

Dietary supplementation with oligofructose 5 grams twice daily for a month

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

OraftiP95

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giles AD Major, BM BCh MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Robin C Spiller, PhD FRCP

Role: STUDY_CHAIR

University of Nottingham

Locations

University of Nottingham

Nottingham, , United Kingdom

Countries

United Kingdom

Related Links

http://www.nddcbru.org.uk

Departmental website

Other Identifiers

14GA012

Identifier Type: OTHER

Identifier Source: secondary_id

UoN14048

Identifier Type: -

Identifier Source: org_study_id