Campylobacter InfectionsCERAMICNCT02040922
Campylobacter Enteritis and Post-Infective Bowel Dysfunction (PI-BD): Role of Antibiotics and Microbiota
An observational study of Campylobacter Infections and Irritable Bowel Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Campylobacter Infections, Irritable Bowel Syndrome
- How many people
- 450 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jun 2017
- Phase
- Observational
- 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
Study population: Adults in the Nottinghamshire area with no previous history of gastrointestinal disorder or surgical resection. Those who submit a stoo lsample from which Campylobacter spp. is cultured will be invited to take part.
Who may be able to join
- Age ≥ 18
- Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
- Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
- Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
Who cannot join
- 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)
Show all 18Show fewer
- 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.
- Use of purgative products/ high dose laxatives for bowel preparation in the four weeks prior to 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
- Declared participation in any medical trials in the past 3 months
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of the Role of Antibiotics, Inflammation and Changes in Microbiota in the Development of Post-infective Bowel Dysfunction Following Infection With Campylobacter Jejuni or Coli
The principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter.
Read the detailed description
The secondary research objectives are:
- To investigate how the particular strain of the Campylobacter germ that causes the infection, and the strength of the immune response that it stimulates in the bowel, affect the risk of long term bowel symptoms.
- To explore what changes occur after Campylobacter infection in the bacteria that usually live in the large bowel (microbiota) and the chemicals that they produce (short-chain fatty acids) when they digest nutrients. We will look for differences between people who recover fully and people who have long term bowel symptoms.
- Conditions
- Campylobacter Infections, Irritable Bowel Syndrome
- Keywords
- Antibiotics, Campylobacter, Diarrhoea, Enteritis, Microbiota, Calprotectin
- Medical subject headings
- Campylobacter Infections, Irritable Bowel Syndrome, Diarrhea, Enteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-Campylobacter | Adults with symptoms of intestinal infection who submit a stool sample from which Campylobacter jejuni or coli is cultured |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yes/ no: Post-Infective bowel dysfunction (PI-BD)
This will be defined by response to the question "have your bowels returned to normal since your Campylobacter infection?"
Measured: 12 weeks after microbiological diagnosis of infection
Secondary outcomes (1)
Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)
Symptoms meeting Rome III criteria for Irritable Bowel Syndrome (other than 6 month duration)
Measured: 12 weeks after microbiological diagnosis of infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2017
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Campylobacter InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Department of Health, United Kingdom, King's College London, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Robin C Spiller, MSc MD FRCP, Study chair, University of NottinghamGiles AD Major, BM BCh MRCP, Principal investigator, University of NottinghamMathew Diggle, MSc PhD, Study director, Nottingham University Hospitals NHS TrustRichard Puleston, MBBS PhD, Study director, University of NottinghamMiranda Lomer, PhD RD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040922
- Sponsor's protocol ID
- 13091
- Other IDs
- 13/EM/0310
- Acronym
- CERAMIC
- Status last verified
- May 2017
- First submitted
- 14 Jan 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jalanka J, Gunn D, Singh G, Krishnasamy S, Lingaya M, Crispie F, Finnegan L, Cotter P, James L, Nowak A, Major G, Spiller RC. Postinfective bowel dysfunction following Campylobacter enteritis is characterised by reduced microbiota diversity and impaired microbiota recovery. Gut. 2023 Mar;72(3):451-459. doi: 10.1136/gutjnl-2021-326828. Epub 2022 Sep 28.
PubMed 36171082
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Role of Antibiotics, Inflammation and Changes in Microbiota in the Development of Post-infective Bowel Dysfunction Following Infection With Campylobacter Jejuni or Coli
- ClinicalTrials.gov ID
- NCT02040922
- Acronym / sponsor ID
- CERAMIC / 13091
- Conditions
- Campylobacter Infections, Irritable Bowel Syndrome
- Keywords
- Antibiotics, Campylobacter, Diarrhoea, Enteritis, Microbiota, Calprotectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Department of Health, United Kingdom, King's College London, University of Helsinki
- Study start
- Jan 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 Jan 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 principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter.
Detailed description
The secondary research objectives are:
- To investigate how the particular strain of the Campylobacter germ that causes the infection, and the strength of the immune response that it stimulates in the bowel, affect the risk of long term bowel symptoms.
- To explore what changes occur after Campylobacter infection in the bacteria that usually live in the large bowel (microbiota) and the chemicals that they produce (short-chain fatty acids) when they digest nutrients. We will look for differences between people who recover fully and people who have long term bowel symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Campylobacter | – | –Adults with symptoms of intestinal infection who submit a stool sample from which Campylobacter jejuni or coli is cultured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults in the Nottinghamshire area with no previous history of gastrointestinal disorder or surgical resection. Those who submit a stoo lsample from which Campylobacter spp. is cultured will be invited to take part.
Key inclusion criteria (4 listed)
- Age ≥ 18
- Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
- Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
- Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
Key exclusion criteria (18 listed)
- Pregnancy declared by the candidate
- History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Yes/ no: Post-Infective bowel dysfunction (PI-BD)
Time frame: 12 weeks after microbiological diagnosis of infection
This will be defined by response to the question "have your bowels returned to normal since your Campylobacter infection?"
1 secondary outcome
Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)
Time frame: 12 weeks after microbiological diagnosis of infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Derived from this study: PubMed 36171082Jalanka J, Gunn D, Singh G, Krishnasamy S, Lingaya M, Crispie F, Finnegan L, Cotter P, James L, Nowak A, Major G, Spiller RC. Postinfective bowel dysfunction following Campylobacter enteritis is characterised by reduced microbiota diversity and impaired microbiota recovery. Gut. 2023 Mar;72(3):451-459. doi: 10.1136/gutjnl-2021-326828. Epub 2022 Sep 28.
- 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.
Robin C Spiller, MSc MD FRCP study chair
University of Nottingham
Giles AD Major, BM BCh MRCP principal investigator
University of Nottingham
Mathew Diggle, MSc PhD study director
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Campylobacter Infections and Irritable Bowel Syndrome, 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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 4 May 2017. 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. 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?
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?
Yes/ no: Post-Infective bowel dysfunction (PI-BD) (time frame: 12 weeks after microbiological diagnosis of infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040922, which also lists 1 linked publication.
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 4 May 2017; AzTrials last refreshed its copy on 27 Oct 2026.