Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

NCT02232373 | Terminated

• 2 other identifiers: UoN1404814GA012
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

FODMAPs; microbiota; oligofructose; IBS; Irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

• Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS

  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.

  1 month after start of diet

Secondary Outcomes (10)

• Moderate or substantial improvement in IBS symptoms

  6 months after star of diet

• Adequate control of IBS symptoms

  1 month after start of diet

• Adequate control of IBS symptoms

  6 months after start of diet

• Percentage of days with loose stool

  during last 14 days of dietary intervention

• Change from baseline in IBSS

  1 month after start of diet

Other Outcomes (6)

• Change from baseline in EQ-5D-5L score

  1 month after start of diet

• 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

Study Arms (2)

Normal FODMAP arm

SHAM COMPARATOR

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; Dietary Supplement: Oligofructose

Low FODMAP arm

EXPERIMENTAL

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

Behavioral: low FODMAP dietary advice; Dietary Supplement: Maltodextrin

Interventions

low FODMAP dietary advice 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.

Low FODMAP arm; Normal FODMAP arm

Maltodextrin DIETARY_SUPPLEMENT

Dietary supplementation with maltodextrin 5 grams twice daily for a month

Low FODMAP arm

Oligofructose DIETARY_SUPPLEMENT

Dietary supplementation with oligofructose 5 grams twice daily for a month

Also known as: OraftiP95

Normal FODMAP arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator
• King's College London: collaborator

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Links

• Departmental website

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Interventions

maltodextrin; oligofructose

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Study Officials

• Giles AD Major, BM BCh MRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Robin C Spiller, PhD FRCP

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 5, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)