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Trial record 44 of 98 for:    grams | maltodextrin

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

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ClinicalTrials.gov Identifier: NCT02232373
Recruitment Status : Terminated (Failure to recruit)
First Posted : September 5, 2014
Last Update Posted : May 13, 2016
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
King's College London
Information provided by (Responsible Party):
University of Nottingham

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

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 Name: 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




Primary Outcome Measures :
  1. Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS [ Time Frame: 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 :
  1. Moderate or substantial improvement in IBS symptoms [ Time Frame: 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.

  2. Adequate control of IBS symptoms [ Time Frame: 1 month after start of diet ]
    Response to a yes/no question "Have your symptoms been adequately controlled?"

  3. Adequate control of IBS symptoms [ Time Frame: 6 months after start of diet ]
    Response to a yes/no question "Have your symptoms been adequately controlled?"

  4. Percentage of days with loose stool [ Time Frame: 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

  5. Change from baseline in IBSS [ Time Frame: 1 month after start of diet ]
    The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders

  6. Change from baseline in IBSS [ Time Frame: 6 months after start of diet ]
  7. Change from baseline in fasting colonic volume [ Time Frame: 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.

  8. Change in fasting colonic gas volume [ Time Frame: 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.

  9. Change from baseline in stool concentration of Bifidobacteria [ Time Frame: 1 month after start of diet ]
    This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention

  10. Change from baseline in stool concentration of Bifidobacteria [ Time Frame: 6 months after start of diet ]
    This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention


Other Outcome Measures:
  1. Change from baseline in EQ-5D-5L score [ Time Frame: 1 month after start of diet ]
    The EQ5D is a validated questionnaire to measure quality of life

  2. Change from baseline in EQ-5D-5L score [ Time Frame: 6 months after start of diet ]
  3. Change from baseline in stool concentration of short-chain fatty acids [ Time Frame: 1 month after start of diet ]
  4. Change from baseline in stool concentration of short-chain fatty acids [ Time Frame: 6 months after start of diet ]
  5. Change from baseline in other clades of stool microbiota [ Time Frame: 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

  6. Change from baseline in other clades of stool microbiota [ Time Frame: 6 months after start of diet ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232373


Locations
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United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust
King's College London
Investigators
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Principal Investigator: Giles AD Major, BM BCh MRCP University of Nottingham
Study Chair: Robin C Spiller, PhD FRCP University of Nottingham

Additional Information:
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02232373     History of Changes
Other Study ID Numbers: UoN14048
14GA012 ( Other Identifier: Nottingham University Hospitals NHS Trust )
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
FODMAPs
microbiota
oligofructose
IBS
Irritable bowel syndrome
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Intestinal Diseases
Digestive System Diseases