Crohn's DiseaseIMPACT-CrohnNCT02097797
Impact of the Fecal Flora Transplantation on Crohn's Disease
A study testing Fecal Transplantation in people with Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Fecal Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to 30 Aug 2017
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 70 years
- Crohn's disease with colonic or ileo-colonic involvement
- Active disease at screening defined by a Harvey Bradshaw Index >4
- Clinical remission (Harvey Bradshaw Index <5) in the 3 weeks following corticosteroid onset
- Patient with health insurance
- Written consent obtained
Show all 11Show fewer
- Age > 20 years and < 50 years
- 27kg/m² > BMI > 17 kg/m²
- Regular bowel movement with usually one bowel movement in the morning
- Subject with health insurance
- Written consent obtained
Who cannot join
- Fistulizing disease
- Anoperineal or abdominal abscess
- Complication requiring surgical treatment
- Treatment with anti-TNFa (ongoing or stopped in the 1 month preceding randomization)
- Immunosuppressant treatment started or stopped in the 3 months preceding randomization
- Non-steroidal anti inflammatory drugs (NSAIDs) intake in the 4 weeks preceding randomization
Show all 54Show fewer
- Antibiotics or antifungic treatment in the 4 weeks preceding colonoscopy
- Probiotics intake in the 4 weeks preceding colonoscopy
- Clostridium difficile infection in the 10 days preceding randomization
- contraindication to colonoscopy or anesthesia
- Pregnancy
- Donor
- Infection risk:
- Known infection by human immunodeficiency virus (HIV), Human T Leukemia Virus (HTLV), Hepatitis B or C virus.
- At risk behavior: Travel (in the preceding 3 months, excepting in Euro area, United Kingdom, Bulgaria, Poland, Romania, Croatia, Hungary, Republic Tcheque, Denmark, Norway, Sweden, Swiss, USA or Canada), at risk sexual activity (intercourse without protection with a new partner) in the preceding 6 months, blood transfusion, piercing or tattoo in the preceding 6 months residence of several years in intertropical area, abroad hospitalization more than 24 hours in the last 12 months (including patient and his immediate family).
- Positive result at one of the screening tests for infectious disease. : HIV, HCV, HBV, HTLV, syphilis, Enteric viruses (Rotavirus, HEV, Adenovirus, Norovirus, Enterovirus, HAV, Poliovirus, Astrovirus, Aichi virus, Sapovirus), parasites in stool (Cyclospora, Isospora, Cryptosporidium, Microsporidium, Strongyloides stercoralis, Entamoeba histolitica, Giardia intestinalis, Dientamoeba fragilis), and in blood (Strongyloides stercoralis, Trichinella spiralis, Amoebiasis), pathogenic bacteria in stool (Clostridium difficile, Shigella, Campylobacter, Yersinia, Salmonella, Listeria monocytogenes, Vibrio cholerae/parahemolyticus, verotoxin-producing E. coli)
- Anal lesions suggesting viral infection or positive test for HSV anal and/or multi-drug resistant bacteria (Enterobacteria producing extended spectrum betalactamase, Actinobacter baumanii, Vancomycin resistant enterococci and carbapenemase producing bacteria).
- Positive test for multidrug resistant bacteria
- If receiver is EBV negative, EBV positive donor will be excluded
- If receiver is CMV negative, CMV positive donor will be excluded.
- If receiver is negative for Toxoplasma gondii, positive donor for Toxoplasma gondii will be excluded
- Known transmissible infectious disease
- Infection (or possible infection) in the 7 days preceding screening
- Risk factors for Creutzfeldt-Jakob disease
- Personal history of Typhoid fever
- Gastrointestinal comorbidity
- Personal history or first degree relative :
- Inflammatory bowel disease
- Coeliac disease
- Personal history of irritable bowel syndrome, chronic constipation, chronic diarrhea
- Personal history of gastrointestinal neoplasia or polyposis
- First degree relative with gastrointestinal neoplasia or polyposis before 60 years old
- Gastrointestinal infection in the 3 preceding months (defined by the occurrence of an acute diarrhea that last less than a week)
- Factors possibly affecting the composition of the microbiota:
- Antibiotics or antifungic intake in the 3 preceding months before FT
- Non-steroidal anti inflammatory drugs (NSAIDs) intake in the 4 weeks preceding FT
- Specific diet (exclusion diet, vegetarian diet)
- Pregnancy
- Immunosuppressant intake (corticosteroids, calcineurin inhibitors, biologics, etc)
- Anti neoplastic chemotherapy
- Hemorrhoid disease
- Personal history or first degree relative with inflammatory or autoimmune disease
- Other Factors :
- Known chronic disease
- Abnormality at initial biological check up: blood cells count, fasting, glycaemia, kidney function, liver tests, haemostasis, calprotectin
- Long term curative therapy
- Recent intake of food allergens related of receiver's known allergy
- between screening and FT :
- At risk behavior (Travel, at risk sexual activity, blood transfusion, piercing tattoo, accidental blood exposure)
- Anal lesions suggestive of viral infection or positivity for HSV in anal area
- Infection or possible infection
- Occurrence of gastro-intestinal symptoms
- Medicine intake in the 48 hours preceding FT (except contraceptive)
- In case of woman: menstruation in the 48 hours preceding FT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Fecal transPlantAtion on MiCrobotia and hosT in Crohn's Disease
Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The purpose of this study is to determine the effect of the fecal flora transplantation on Crohn's disease.
Read the detailed description
Introduction : Crohn's disease (CD) is an relapsing inflammatory bowel disease relatively frequent. Its prevalence is about 1 for 700 in France, affecting predominantly young adults. Its treatment is based on immunosuppressants that might be associated with potentially severe complications such as infection and cancers. Moreover, these treatments are expensive. The gut microbiota being involved in the disease pathogenesis, it can be considered as a potential therapeutic target.
CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts. The complete replacement of a dysbiotic microbiota by a "healthy" one is thus an attractive strategy. Fecal transplantation (FT) has been used with success for a long time in the context of Clostridium difficile.
Hypothesis : Fecal transplantation allow the replacement of a dysbiotic microbiota by a " healthy " one with favorable impact on CD evolution.
Primary endpoint : In CD patient with colonic or ileo-colonic involvement put in remission with corticosteroids, Evaluate if FT can modify a dysbiotic fecal microbiota to be closer of the one of a healthy donor.
Methodology
For the Receiver :
Once corticoid-induced remission will be achieved, the patient will be included and randomised to receive either FT or sham transplantation during a colonoscopy. The patient will be evaluated at week 2, 6, 10, 14, 18 and 24. At week 6, a colonoscopy will be performed.
For the Donor :
Donors will be recruited by poster advertising. When a receiver will be included, 3 donors will be contacted to attend an inclusion visit including physical examination as well as blood and stool screening for pathogen. The 3 donors will then come the day of the FT to donate their stool.
- Conditions
- Crohn's Disease
- Being tested
- Fecal Transplantation, Sham Transplantation
- Keywords
- Inflammatory bowel disease, Crohn's disease, microbiota, fecal transplantation
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal TransplantationOther
Fecal microbiota (50-100g of stool from donor resuspended in 250-350ml of physiological serum and filtered) given by infusion in coecum during colonoscopy
Sham TransplantationOther
250-350ml of physiological serum given by infusion in coecum during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fecal Transplantation | Experimental | patients receiving the fecal transplant (fecal microbiota from a healthy donor) Receives: Other: Fecal Transplantation |
| Sham Transplantation | Sham comparator | patients receiving the vehicle (Physiological serum) Receives: Other: Sham Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FT success defined by : Sorensen's index [receiver 6 weeks after FT vs donor] > Sorensen's index [receiver 6 weeks after FT vs receiver before FT]) with Sorensen's index [receiver 6 weeks after FT vs donor] ≥ 0.6.
In other words, FT success is reached if the fecal microbiota of the receiver 6 weeks after FT is closer of the fecal microbiota of the donor that of the receiver before FT.
Fecal microbiota composition will be assessed by 454 pyrosequencing (16S RNA) and microbiota comparison will be done using Sorensen's index.
Measured: 6 weeks after FT
Secondary outcomes (10)
FT feasibility
evaluate the feasibility of the FT procedure (frequency of evaluable patients in each group)
Measured: 6 weeks after FT
Clinical relapse rate in the 24 weeks following FT procedure
Clinical relapse defined by a Crohn's disease activity index (CDAI) > 220 points, or by a CDAI between 150 and 220 with an increase >70 compared with baseline, or by the need of surgery or to start a medical treatment for CD.
Measured: 24 weeks following FT
Effect of FT compared to sham transplantation on CRP
Effect of FT compared to sham transplantation on CRP level.
Measured: 6 weeks after FT
Effect of FT compared to sham transplantation on Leukocytes level
Effect of FT compared to sham transplantation on: Leukocytes level
Measured: 6 weeks after FT
Effect of FT compared to sham transplantation on fecal calprotectin
Effect of FT compared to sham transplantation on: fecal calprotectin
Measured: 6 weeks after FT
Effect of FT compared to sham transplantation on Crohn's Disease Endoscopic Index of Severity
Effect of FT compared to sham transplantation on: Crohn's Disease Endoscopic Index of Severity
Measured: 6 weeks after FT
Effect of FT compared to sham transplantation on fecal microbiota composition
Effect of FT compared to sham transplantation on: fecal microbiota composition
Measured: 6 weeks after FT
Effect of FT compared to sham transplantation on lymphocytes population in blood
Effect of FT compared to sham transplantation on: lymphocytes population in blood
Measured: 6 weeks after FT
Effect of FT compared to sham transplantation on lymphocytes population in colon
Effect of FT compared to sham transplantation on: lymphocytes population in colon.
Measured: 6 weeks after FT
Effect of FT compared to sham transplantation on colon transcriptomics
Effect of FT compared to sham transplantation on: colon transcriptomics.
Measured: 6 weeks after FT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion25 Apr 2017
- Study completion30 Aug 2017
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 Crohn's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Pierre and Marie Curie University, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Harry Sokol, MD, PhD, Study director, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097797
- Sponsor's protocol ID
- P 121104
- Acronym
- IMPACT-Crohn
- Status last verified
- Jan 2018
- First submitted
- 26 Feb 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sokol H, Landman C, Seksik P, Berard L, Montil M, Nion-Larmurier I, Bourrier A, Le Gall G, Lalande V, De Rougemont A, Kirchgesner J, Daguenel A, Cachanado M, Rousseau A, Drouet E, Rosenzwajg M, Hagege H, Dray X, Klatzman D, Marteau P; Saint-Antoine IBD Network; Beaugerie L, Simon T. Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. Microbiome. 2020 Feb 3;8(1):12. doi: 10.1186/s40168-020-0792-5.
PubMed 32014035
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fecal transPlantAtion on MiCrobotia and hosT in Crohn's Disease
- ClinicalTrials.gov ID
- NCT02097797
- Acronym / sponsor ID
- IMPACT-Crohn / P 121104
- Conditions
- Crohn's Disease
- Keywords
- Inflammatory bowel disease, Crohn's disease, microbiota, fecal transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Pierre and Marie Curie University, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- May 2014
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 27 Mar 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.
Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The purpose of this study is to determine the effect of the fecal flora transplantation on Crohn's disease.
Detailed description
Introduction : Crohn's disease (CD) is an relapsing inflammatory bowel disease relatively frequent. Its prevalence is about 1 for 700 in France, affecting predominantly young adults. Its treatment is based on immunosuppressants that might be associated with potentially severe complications such as infection and cancers. Moreover, these treatments are expensive. The gut microbiota being involved in the disease pathogenesis, it can be considered as a potential therapeutic target.
CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts. The complete replacement of a dysbiotic microbiota by a "healthy" one is thus an attractive strategy. Fecal transplantation (FT) has been used with success for a long time in the context of Clostridium difficile.
Hypothesis : Fecal transplantation allow the replacement of a dysbiotic microbiota by a " healthy " one with favorable impact on CD evolution.
Primary endpoint : In CD patient with colonic or ileo-colonic involvement put in remission with corticosteroids, Evaluate if FT can modify a dysbiotic fecal microbiota to be closer of the one of a healthy donor.
Methodology
For the Receiver :
Once corticoid-induced remission will be achieved, the patient will be included and randomised to receive either FT or sham transplantation during a colonoscopy. The patient will be evaluated at week 2, 6, 10, 14, 18 and 24. At week 6, a colonoscopy will be performed.
For the Donor :
Donors will be recruited by poster advertising. When a receiver will be included, 3 donors will be contacted to attend an inclusion visit including physical examination as well as blood and stool screening for pathogen. The 3 donors will then come the day of the FT to donate their stool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Transplantation | Experimental | Other: Fecal Transplantationpatients receiving the fecal transplant (fecal microbiota from a healthy donor) |
| Sham Transplantation | Sham comparator | Other: Sham Transplantationpatients receiving the vehicle (Physiological serum) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18 years and < 70 years
- Crohn's disease with colonic or ileo-colonic involvement
- Active disease at screening defined by a Harvey Bradshaw Index >4
- Clinical remission (Harvey Bradshaw Index <5) in the 3 weeks following corticosteroid onset
- Patient with health insurance
Key exclusion criteria (54 listed)
- Fistulizing disease
- Anoperineal or abdominal abscess
- Complication requiring surgical treatment
- Treatment with anti-TNFa (ongoing or stopped in the 1 month preceding randomization)
- Immunosuppressant treatment started or stopped in the 3 months preceding randomization
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 |
|---|---|---|
| Fecal TransplantationFecal microbiota (50-100g of stool from donor resuspended in 250-350ml of physiological serum and filtered) given by infusion in coecum during colonoscopy | Other | Fecal Transplantation |
| Sham Transplantation250-350ml of physiological serum given by infusion in coecum during colonoscopy | Other | Sham Transplantation |
Primary outcome
FT success defined by : Sorensen's index [receiver 6 weeks after FT vs donor] > Sorensen's index [receiver 6 weeks after FT vs receiver before FT]) with Sorensen's index [receiver 6 weeks after FT vs donor] ≥ 0.6.
Time frame: 6 weeks after FT
In other words, FT success is reached if the fecal microbiota of the receiver 6 weeks after FT is closer of the fecal microbiota of the donor that of the receiver before FT. Fecal microbiota composition will be assessed by 454 pyrosequencing (16S RNA) and microbiota comparison will be done using Sorensen's index.
10 secondary outcomes
FT feasibility
Time frame: 6 weeks after FT
Clinical relapse rate in the 24 weeks following FT procedure
Time frame: 24 weeks following FT
Effect of FT compared to sham transplantation on CRP
Time frame: 6 weeks after FT
Effect of FT compared to sham transplantation on Leukocytes level
Time frame: 6 weeks after FT
Effect of FT compared to sham transplantation on fecal calprotectin
Time frame: 6 weeks after FT
Effect of FT compared to sham transplantation on Crohn's Disease Endoscopic Index of Severity
Time frame: 6 weeks after FT
Effect of FT compared to sham transplantation on fecal microbiota composition
Time frame: 6 weeks after FT
Effect of FT compared to sham transplantation on lymphocytes population in blood
Time frame: 6 weeks after FT
Effect of FT compared to sham transplantation on lymphocytes population in colon
Time frame: 6 weeks after FT
Effect of FT compared to sham transplantation on colon transcriptomics
Time frame: 6 weeks after FT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 32014035Sokol H, Landman C, Seksik P, Berard L, Montil M, Nion-Larmurier I, Bourrier A, Le Gall G, Lalande V, De Rougemont A, Kirchgesner J, Daguenel A, Cachanado M, Rousseau A, Drouet E, Rosenzwajg M, Hagege H, Dray X, Klatzman D, Marteau P; Saint-Antoine IBD Network; Beaugerie L, Simon T. Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. Microbiome. 2020 Feb 3;8(1):12. doi: 10.1186/s40168-020-0792-5.
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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.
Harry Sokol, MD, PhD study director
Assistance Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Transplantation in people with Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 inclusion and 54 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: finished, as of the sponsor's last update on 5 Feb 2018. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FT success defined by : Sorensen's index [receiver 6 weeks after FT vs donor] > Sorensen's index [receiver 6 weeks after FT vs receiver before FT]) with Sorensen's index [receiver 6 weeks after FT vs donor] ≥ 0.6. (time frame: 6 weeks after FT). 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 NCT02097797, 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 5 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.