Post-infective Bowel DysfunctionCEDRICNCT02232373
Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates
A study testing low FODMAP dietary advice, Maltodextrin and Oligofructose in people with Post-infective Bowel Dysfunction and Functional Gastrointestinal Disorders, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-infective Bowel Dysfunction, Functional Gastrointestinal Disorders
- What is being tested?
- low FODMAP dietary advice, Maltodextrin and Oligofructose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- low FODMAP dietary advice, Maltodextrin, Oligofructose
- Keywords
- FODMAPs, microbiota, oligofructose, IBS, Irritable bowel syndrome
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low FODMAP dietary adviceBehavioural
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.
MaltodextrinDietary supplement
Dietary supplementation with maltodextrin 5 grams twice daily for a month
OligofructoseDietary supplement
Also called OraftiP95
Dietary supplementation with oligofructose 5 grams twice daily for a month
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: low FODMAP dietary advice; Dietary Supplement: Oligofructose |
| Low FODMAP arm | Experimental | Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate) Receives: Behavioral: low FODMAP dietary advice; Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after start of diet
Secondary outcomes (10)
Moderate or substantial improvement in IBS symptoms
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.
Measured: 6 months after star of diet
Adequate control of IBS symptoms
Response to a yes/no question "Have your symptoms been adequately controlled?"
Measured: 1 month after start of diet
Adequate control of IBS symptoms
Response to a yes/no question "Have your symptoms been adequately controlled?"
Measured: 6 months after start of diet
Percentage of days with loose stool
Percentage of days with at least one stool of consistency type 6 or 7 on the Bristol stool form scale
Measured: during last 14 days of dietary intervention
Change from baseline in IBSS
The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders
Measured: 1 month after start of diet
Change from baseline in IBSS
Measured: 6 months after start of diet
Change from baseline in fasting colonic volume
This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.
Measured: 1 month after start of diet
Change in fasting colonic gas volume
This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.
Measured: 1 month after start of diet
Change from baseline in stool concentration of Bifidobacteria
This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention
Measured: 1 month after start of diet
Change from baseline in stool concentration of Bifidobacteria
This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention
Measured: 6 months after start of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-infective Bowel DysfunctionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, King's College London
- Responsible party
- Sponsor
- Investigators
- Giles AD Major, BM BCh MRCP, Principal investigator, University of NottinghamRobin C Spiller, PhD FRCP, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232373
- Sponsor's protocol ID
- UoN14048
- Other IDs
- 14GA012
- Acronym
- CEDRIC
- Status last verified
- May 2016
- First submitted
- 2 Sep 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02232373
- Acronym / sponsor ID
- CEDRIC / UoN14048
- Keywords
- FODMAPs, microbiota, oligofructose, IBS, Irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, King's College London
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal FODMAP arm | Sham comparator | Behavioral: low FODMAP dietary advice, Dietary Supplement: OligofructoseLow FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet. |
| Low FODMAP arm | Experimental | Behavioral: low FODMAP dietary advice, Dietary Supplement: MaltodextrinLow FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low FODMAP dietary adviceAn 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. | Behavioural | Low FODMAP arm, Normal FODMAP arm |
| MaltodextrinDietary supplementation with maltodextrin 5 grams twice daily for a month | Dietary supplement | Low FODMAP arm |
| OligofructoseAlso: OraftiP95Dietary supplementation with oligofructose 5 grams twice daily for a month | Dietary supplement | Normal FODMAP arm |
Primary outcome
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.
10 secondary outcomes
Moderate or substantial improvement in IBS symptoms
Time frame: 6 months after star of diet
Adequate control of IBS symptoms
Time frame: 1 month after start of diet
Adequate control of IBS symptoms
Time frame: 6 months after start of diet
Percentage of days with loose stool
Time frame: during last 14 days of dietary intervention
Change from baseline in IBSS
Time frame: 1 month after start of diet
Change from baseline in IBSS
Time frame: 6 months after start of diet
Change from baseline in fasting colonic volume
Time frame: 1 month after start of diet
Change in fasting colonic gas volume
Time frame: 1 month after start of diet
Change from baseline in stool concentration of Bifidobacteria
Time frame: 1 month after start of diet
Change from baseline in stool concentration of Bifidobacteria
Time frame: 6 months after start of diet
Results and safety
The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Departmental websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giles AD Major, BM BCh MRCP principal investigator
University of Nottingham
Robin C Spiller, PhD FRCP study chair
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low FODMAP dietary advice, Maltodextrin and Oligofructose in people with Post-infective Bowel Dysfunction and Functional Gastrointestinal Disorders, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS (time frame: 1 month after start of diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.