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Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

NCT02232373 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-05-13

No results posted yet for this study

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

Interventions

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

DIETARY_SUPPLEMENT

Oligofructose

Dietary supplementation with oligofructose 5 grams twice daily for a month

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Giles AD Major, BM BCh MRCP · University of Nottingham

  • Robin C Spiller, PhD FRCP · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02232373 on ClinicalTrials.gov