Crohn DiseasePhase 2TEOREMNCT02620007
Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease
A Phase 2 study testing Ciprofloxacin and Rifaximin in people with Crohn Disease and Adherent-invasive E. Coli, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Adherent-invasive E. Coli
- What is being tested?
- Ciprofloxacin and Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2015to Jun 2022
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD of the ileum, with or without involvement of the caecum or the right colon
- Colonoscopy showing active lesions defined by a CDEISm score >6
- Informed consent to participate in this study
- Prescription of steroid treatments : Budesonide, Prednisone (or Prednisolone) independently from entry in study
- Patients who respond to budesonide (initial dose 9 mg/d) or prednisone or prednisolone (initial dose 40 mg/d), defined as a 70 points decrease in CDAI between the pre-inclusion and the inclusion visit,
- Patients colonized with AIEC on initial ileal biopsies.
Who cannot join
- Ileal stenosis that cannot be crossed by the endoscope,
- Infliximab treatment received less than 8 weeks before inclusion in this study,
- Adalimumab treatment received less than 4 weeks before inclusion in this study,
- Vedolizumab treatment received less than 8 weeks before inclusion in the study,
- Hypersensitivity to Ciprofloxacin, to other quinolones, or to any of the excipients (cellulose microcrystalline, crospovidone, maize starch, magnesium stearate, silica colloidal anhydrous,, hypromellose titanium dioxide E171, macrogol 4000,),
- Tizanidine, Probenecid, Theophylline, Xanthine derivatives, Phenytoin, oral anticoagulants, and Ropinirole treatment,
Show all 17Show fewer
- Hypersensitivity to Rifaximin, or to any excipients (sodium starch glycolate type A, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide, disodium edentate, propylene glycol, red iron oxide E172),
- Previous extensive ileal surgery (≥ 1 meter as measured on the pathology and/or surgical report),
- Short bowel syndrome,
- Need for an intestinal resection for fistula, abscess or intestinal obstruction,
- Renal failure (creatinine clearance<30 mL/min/1.73m2),
- Liver failure (V factor<50%),
- Past history of epilepsy,
- No health insurance,
- Pregnant or lactating women,
- Refusal to have a double effective contraception,
- Patients already included in a biomedical research other than an observational study (e.g: registry, cohort).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Kremlin-Bicetre hospital
Le Kremlin-Bicêtre, 94043
Gastroenterology department
Le Kremlin-Bicêtre, 94
About this study
Official title: Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease
The primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon.
- Conditions
- Crohn Disease, Adherent-invasive E. Coli
- Being tested
- Ciprofloxacin, Rifaximin, Ciprofloxacin Placebo, Rifaximin Placebo
- Keywords
- Adult, AIEC
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
oral Ciprofloxacin 500 mg bis in die (bid) for 12 weeks
RifaximinDrug
oral Rifaximin 800 mg bid for 12 weeks
Ciprofloxacin PlaceboDrug
a placebo of Ciprofloxacin bid for 12 weeks
Rifaximin PlaceboDrug
a placebo of Rifaximin bid for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks Receives: Drug: Ciprofloxacin; Drug: Rifaximin |
| Control arm | Placebo comparator | a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks Receives: Drug: Ciprofloxacin Placebo; Drug: Rifaximin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
(assessed within each site quotation), defined by the modified Crohn's Disease Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3, as compared to baseline values.
Measured: week 12
Secondary outcomes (8)
Mean variation of CDEISm
assessed by centralized, anonymous and blinded reading of ileocolonoscopies
Measured: week 12
Complete endoscopic remission
assessed by centralized, anonymous and blinded reading of ileocolonoscopies, and defined by a CDEISm <3
Measured: week 12
No ulceration
Measured: week 12
Clinical remission
defined by Crohn's disease activity index (CDAI)<150 without steroids, anti-Tumor Necrosis Factor (TNF), and surgery
Measured: 12 and 48 weeks
Microbiota composition
Measured: weeks 12 and 48
lpf positive AIEC bacteria in the stools
Detection (by PCR)
Measured: weeks 12 and 48
Biological remission
defined by haemoglobin level ≥13g/dL and C-Reactive Protein (CRP) serum level ≤5 mg/L and fecal calprotectin <300 mg/L
Measured: weeks 4, 8, 12, 24, 36 and 48
Side effects
adverse events
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2021
- Study completionJun 2022
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Barnich, MD PhD, Study chair, Intestinal bacterial pathogenesis laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620007
- Sponsor's protocol ID
- P140503
- Acronym
- TEOREM
- Status last verified
- Feb 2019
- First submitted
- 30 Nov 2015
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease
- ClinicalTrials.gov ID
- NCT02620007
- Acronym / sponsor ID
- TEOREM / P140503
- Conditions
- Crohn Disease, Adherent-invasive E. Coli
- Keywords
- Adult, AIEC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2021 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 2 Dec 2015 (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 primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon.
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 |
|---|---|---|
| Experimental arm | Experimental | Drug: Ciprofloxacin, Drug: Rifaximinoral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks |
| Control arm | Placebo comparator | Drug: Ciprofloxacin Placebo, Drug: Rifaximin Placeboa placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CD of the ileum, with or without involvement of the caecum or the right colon
- Colonoscopy showing active lesions defined by a CDEISm score >6
- Informed consent to participate in this study
- Prescription of steroid treatments : Budesonide, Prednisone (or Prednisolone) independently from entry in study
- Patients who respond to budesonide (initial dose 9 mg/d) or prednisone or prednisolone (initial dose 40 mg/d), defined as a 70 points decrease in CDAI between the pre-inclusion and the inclusion visit,
Key exclusion criteria (17 listed)
- Ileal stenosis that cannot be crossed by the endoscope,
- Infliximab treatment received less than 8 weeks before inclusion in this study,
- Adalimumab treatment received less than 4 weeks before inclusion in this study,
- Vedolizumab treatment received less than 8 weeks before inclusion in the study,
- Hypersensitivity to Ciprofloxacin, to other quinolones, or to any of the excipients (cellulose microcrystalline, crospovidone, maize starch, magnesium stearate, silica colloidal anhydrous,, hypromellose titanium dioxide E171, macrogol 4000,),
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 |
|---|---|---|
| Ciprofloxacinoral Ciprofloxacin 500 mg bis in die (bid) for 12 weeks | Drug | Experimental arm |
| Rifaximinoral Rifaximin 800 mg bid for 12 weeks | Drug | Experimental arm |
| Ciprofloxacin Placeboa placebo of Ciprofloxacin bid for 12 weeks | Drug | Control arm |
| Rifaximin Placeboa placebo of Rifaximin bid for 12 weeks | Drug | Control arm |
Primary outcome
Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
Time frame: week 12
(assessed within each site quotation), defined by the modified Crohn's Disease Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3, as compared to baseline values.
8 secondary outcomes
Mean variation of CDEISm
Time frame: week 12
Complete endoscopic remission
Time frame: week 12
No ulceration
Time frame: week 12
Clinical remission
Time frame: 12 and 48 weeks
Microbiota composition
Time frame: weeks 12 and 48
lpf positive AIEC bacteria in the stools
Time frame: weeks 12 and 48
Biological remission
Time frame: weeks 4, 8, 12, 24, 36 and 48
Side effects
Time frame: week 12
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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.
Nicolas Barnich, MD PhD study chair
Intestinal bacterial pathogenesis laboratory
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciprofloxacin and Rifaximin in people with Crohn Disease and Adherent-invasive E. Coli, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 6 inclusion and 17 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). 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?
Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3 (time frame: week 12). 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 23 Aug 2023.