Ulcerative ColitisNCT02734589
Fecal Transplantation Using a Diet for Donor and Recipient in Refractory Colitis
A study testing Fecal transplantation, Unique novel Diet for UC and Unique novel Diet for the donor + FMT and Unique novel Diet for UC in people with Ulcerative Colitis, run by Wolfson Medical Center at 5 sites in 3 countries.
Trial summary
Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal transplantation, Unique novel Diet for UC and Unique novel Diet for the donor + FMT and Unique novel Diet for UC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 24 Jan 2017to 30 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Established diagnosis of UC, disease confined to the large intestine, involving the rectosigmoid for at least 3 months.
- Age: 18 - 70 years ( inclusive)
- Mild to Moderate active disease, SCCAI of ≥5 and <10 with endoscopic subscore≥2
- Refractory to mesalamine 6 weeks, or steroids > 14 days, or immunomodulator 12 weeks or biologics at least 12 weeks therapy.
- No use or stable use for 2 weeks of medical cannabis.
- 1. Patients can enter the trial if they are on steroids if they have been treated for at least two weeks with 40 mg prednisone or an intravenous steroid such as methylprednisolone and still suffer from a mild to moderate active disease.
Who cannot join
- Start of a new biologic in the previous 12 weeks.
- Evidence for Clostridium difficile infection.
- Any proven current infection such as CMV, positive stool culture or parasite.
- Current Extra intestinal manifestation of UC such as active arthritis or primary sclerosing cholangitis (PSC).
- Immune deficiency (other than drug induced).
- Current use of a calcineurin inhibitor
Show all 23Show fewer
- Pregnancy.
- Suspected toxic megacolon, guarding on palpation, or signs of peritoneal inflammation
- Patients with other IBD unrelated disease such as autoimmune disorders, renal failure, fever or current infection (UTI, strep throat, pneumonia, etc), prior or current neoplasia
- Fecal Transplantation in the last 6 months.
- Fever >38
- Participation in another clinical interventional trial
- An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC).
- Inability or reluctance to use an enema.
- Anticipation for antibiotic use within the study period (such as for elective surgery or dental treatment).
- Acute severe UC in the past 3 months.
- Presence of a pouch or pouchitis.
- Patients > 60 years old using chronic medications except for the treatment for colitis.
- Patients will be excluded from the analysis if during the study and after the initial fecal transplant they did not perform the enemas, used antibiotics prior to day 42. Patients who required additional therapy such as additional FMT, steroids biologics or immunomodulators during the first 8 weeks will be considered failures on an intention to treat basis.
- Patients with mayo< 2 at the baseline colonoscopy may receive the FMT and continue the follow up according to the protocol as an open lable based on the randomization. Those patients will be excluded from the final analysis.
- Special populations (e.g children, unable to sign an informed consent, those under a guardian) and pregnant women will also be excluded.
- Donors:
- Donors will sign an informed consent and will be screened and included only if they satisfy the rigorous screening criteria of the protocol of the Ministry of Health of Israel for stool donors for Clostridium difficile infection which includes a list of medical and behavioral conditions as well as transmissible pathogens that need to be screened by history, anthropometry, blood and stool tests (available as supplement).
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Israel2 sites
Wolfson Medical Center
Holon, 58100
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy2 sites
Humanitas Clinical and Research Center
Milan
Catholic University of the Secret Heart
Rome
France1 site
Saint-Antoine Hospital, Universite Pierre et Marie Curie
Paris, 75571
About this study
Official title: Fecal Transplantation Using a Novel Conditioning Method for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease
Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.
Read the detailed description
Study type- It will be an open label 3 arm multicenter randomized controlled single blinded study, with review of endoscopic activity by blinded reviewers. Patients will be randomized to one of three groups; Group 1 will undergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 from the same donor without dietary conditioning, while Group 2 will undergo the same transplantation (colonoscopy and enemas at night day 2 and day 14), with dietary pre-conditioning of the donor for 14 days and dietary treatment of the recipient immediately after transplantation and for the following 12 weeks.We will attempt to use the same donors for group 1 and 2 by using the preconditioning stool for group 1 and the post conditioning stool for group 2 in order to control for the "donor effect". Group 3 will receive dietary therapy only.Physicians will be blinded to treatment arm and donors used within the transplantation arms. A data safety monitoring board will review safety after the first 34 patients to make sure that there is no ethical problem with continuing the study. The investigators will continue the fecal transplantation trial to reach our target enrolment number ( 76 patients) for transplantation + 20 dietary controls.
Subjects may continue their stable medications but should not start new medications during the 8 week period unless they fail to respond. Steroid weaning can commenced from day 14.
Patients will be seen on weeks0, 2, 6, 8, 12 and during week 20. Week 6 will be only a dietitian visit. The last visit is a visit off diet to evaluate sustainability of the initial intervention, safety and changes in BMI due to FT or diet. A telephone conversation to assess SCCAI will be made at week 1 and week 7. At each visit (weeks 0, 2, 6, 8, 12, 20) patients will have Weight, a disease activity score, PGA, CBC, CRP, albumin and complete chemistry panel performed. Adverse events and medications used will be recorded at each visit.Stool samples for microbiome (16S rDNA, Short chain fatty acid analysis) and Calprotectin will be measured locally at baseline, weeks 2, 8 and 12. All patients (patients in group 1,2 and 3) will have a repeat sigmoidoscopy performed at week 8. A food frequency questionnaire will be performed on week 0 and a food diary will be collected at week 2 and 12. A compliance questionnaire will be completed on weeks 2, 8and 12. A 24 hours recall will be collected at weeks 0, 2 and 6.
Patients in group 1 or 2 in remission from FT, may receive up to 2 rescue enemas during the 8 weeks of the study from their original donor.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal transplantation, Unique novel Diet for UC and Unique novel Diet for the donor + FMT, Unique novel Diet for UC
- Keywords
- Ulcerative Colitis, Nutrition, microbiome
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal transplantationOther
Also called Fecal microbiota transplantation (FMT)
Transplantation of fecal bacteria from a healthy individual into a recipient- ulcerative colitis patient via colonoscopy and enemas
Unique novel Diet for UC and Unique novel Diet for the donor + FMTOther
Also called Ulcerative Colitis Diet (UCD) and the conditioning diet
A developed unique diet that is geared to induces remission and decreases inflammation in patients with active UC. Also a conditioning diet for healthy subjects to be used by the donor prior to transplantation- a developed unique diet for two weeks.
Unique novel Diet for UCOther
Also called Ulcerative Colitis Diet (UCD)
A developed diet that is geared to induces remission and decreases inflammation in patients with active UC.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation (FMT) without Diet | Active comparator | undergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 from the same donor without dietary conditioning. Receives: Other: Fecal transplantation |
| FMT with Diet for the donor and for the recipient | Experimental | undergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 with dietary pre-conditioning of the donor for 14 days and dietary treatment of the recipient immediately after transplantation and for the following 12 weeks. Receives: Other: Unique novel Diet for UC and Unique novel Diet for the donor + FMT |
| Dietary therapy only | Active comparator | The patient will receive detailed instructions regarding the UC diet to be used over 12 weeks without FMT. Receives: Other: Unique novel Diet for UC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
determined by Simple Clinical Colitis Activity Index (SCCAI) score <3 at week 8
Measured: Day 56
Secondary outcomes (6)
Improvement
Improvement in the Simple Clinical Colitis Activity Index (SCCAI) score at weeks 8 \& 12 for each of the groups
Measured: Days 56 & 84
Endoscopic resutls
Mayo endoscopic score <2 (for patients performing sigmoidoscopy)
Measured: Day 56
Calprotectin
Calprotectin < 250 µg/g
Measured: Day 56
The need for additional therapy or flare
According to the physician discretion
Measured: Week 12
change in the microbiome compared to baseline.
According to analysis of fecal samples
Measured: For donor- day 14 and for recipient day 56
endoscopic SCCAI
endoscopic SCCAI score at week 8 for each of the groups
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start24 Jan 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Why it stopped: DSMB recommendation of stopping the trial after reviewing the interim data
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 Ulcerative ColitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Arie Levine, Wolfson Medical Center
- Investigators
- Arie Levine, MD, Principal investigator, Wolfson Medical CenterYona Avni, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734589
- Sponsor's protocol ID
- 0070-15
- Status last verified
- May 2022
- First submitted
- 28 Mar 2016
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, Cohen NA, Ron Y, Fliss Isakov N, Pfeffer J, Yaakov M, Fanali C, Turchini L, Masucci L, Quaranta G, Kolonimos N, Godneva A, Weinberger A, Kopylov U, Levine A, Maharshak N. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial. J Crohns Colitis. 2022 Mar 14;16(3):369-378. doi: 10.1093/ecco-jcc/jjab165.
PubMed 34514495
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Transplantation Using a Novel Conditioning Method for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02734589
- Acronym / sponsor ID
- 0070-15
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Nutrition, microbiome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation of stopping the trial after reviewing the interim data
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 12 Apr 2016 (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.
Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.
Detailed description
Study type- It will be an open label 3 arm multicenter randomized controlled single blinded study, with review of endoscopic activity by blinded reviewers. Patients will be randomized to one of three groups; Group 1 will undergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 from the same donor without dietary conditioning, while Group 2 will undergo the same transplantation (colonoscopy and enemas at night day 2 and day 14), with dietary pre-conditioning of the donor for 14 days and dietary treatment of the recipient immediately after transplantation and for the following 12 weeks.We will attempt to use the same donors for group 1 and 2 by using the preconditioning stool for group 1 and the post conditioning stool for group 2 in order to control for the "donor effect". Group 3 will receive dietary therapy only.Physicians will be blinded to treatment arm and donors used within the transplantation arms. A data safety monitoring board will review safety after the first 34 patients to make sure that there is no ethical problem with continuing the study. The investigators will continue the fecal transplantation trial to reach our target enrolment number ( 76 patients) for transplantation + 20 dietary controls.
Subjects may continue their stable medications but should not start new medications during the 8 week period unless they fail to respond. Steroid weaning can commenced from day 14.
Patients will be seen on weeks0, 2, 6, 8, 12 and during week 20. Week 6 will be only a dietitian visit. The last visit is a visit off diet to evaluate sustainability of the initial intervention, safety and changes in BMI due to FT or diet. A telephone conversation to assess SCCAI will be made at week 1 and week 7. At each visit (weeks 0, 2, 6, 8, 12, 20) patients will have Weight, a disease activity score, PGA, CBC, CRP, albumin and complete chemistry panel performed. Adverse events and medications used will be recorded at each visit.Stool samples for microbiome (16S rDNA, Short chain fatty acid analysis) and Calprotectin will be measured locally at baseline, weeks 2, 8 and 12. All patients (patients in group 1,2 and 3) will have a repeat sigmoidoscopy performed at week 8. A food frequency questionnaire will be performed on week 0 and a food diary will be collected at week 2 and 12. A compliance questionnaire will be completed on weeks 2, 8and 12. A 24 hours recall will be collected at weeks 0, 2 and 6.
Patients in group 1 or 2 in remission from FT, may receive up to 2 rescue enemas during the 8 weeks of the study from their original donor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation (FMT) without Diet | Active comparator | Other: Fecal transplantationundergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 from the same donor without dietary conditioning. |
| FMT with Diet for the donor and for the recipient | Experimental | Other: Unique novel Diet for UC and Unique novel Diet for the donor + FMTundergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 with dietary pre-conditioning of the donor for 14 days and dietary treatment of the recipient immediately after transplantation and for the following 12 weeks. |
| Dietary therapy only | Active comparator | Other: Unique novel Diet for UCThe patient will receive detailed instructions regarding the UC diet to be used over 12 weeks without FMT. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent
- Established diagnosis of UC, disease confined to the large intestine, involving the rectosigmoid for at least 3 months.
- Age: 18 - 70 years ( inclusive)
- Mild to Moderate active disease, SCCAI of ≥5 and <10 with endoscopic subscore≥2
- Refractory to mesalamine 6 weeks, or steroids > 14 days, or immunomodulator 12 weeks or biologics at least 12 weeks therapy.
Key exclusion criteria (23 listed)
- Start of a new biologic in the previous 12 weeks.
- Evidence for Clostridium difficile infection.
- Any proven current infection such as CMV, positive stool culture or parasite.
- Current Extra intestinal manifestation of UC such as active arthritis or primary sclerosing cholangitis (PSC).
- Immune deficiency (other than drug induced).
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 transplantationAlso: Fecal microbiota transplantation (FMT)Transplantation of fecal bacteria from a healthy individual into a recipient- ulcerative colitis patient via colonoscopy and enemas | Other | Fecal microbiota transplantation (FMT) without Diet |
| Unique novel Diet for UC and Unique novel Diet for the donor + FMTAlso: Ulcerative Colitis Diet (UCD) and the conditioning dietA developed unique diet that is geared to induces remission and decreases inflammation in patients with active UC. Also a conditioning diet for healthy subjects to be used by the donor prior to transplantation- a developed unique diet for two weeks. | Other | FMT with Diet for the donor and for the recipient |
| Unique novel Diet for UCAlso: Ulcerative Colitis Diet (UCD)A developed diet that is geared to induces remission and decreases inflammation in patients with active UC. | Other | Dietary therapy only |
Primary outcome
Clinical remission
Time frame: Day 56
determined by Simple Clinical Colitis Activity Index (SCCAI) score <3 at week 8
6 secondary outcomes
Improvement
Time frame: Days 56 & 84
Endoscopic resutls
Time frame: Day 56
Calprotectin
Time frame: Day 56
The need for additional therapy or flare
Time frame: Week 12
change in the microbiome compared to baseline.
Time frame: For donor- day 14 and for recipient day 56
endoscopic SCCAI
Time frame: Day 56
Results and safety
The study was stopped early (reason given: DSMB recommendation of stopping the trial after reviewing the interim data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 34514495Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, Cohen NA, Ron Y, Fliss Isakov N, Pfeffer J, Yaakov M, Fanali C, Turchini L, Masucci L, Quaranta G, Kolonimos N, Godneva A, Weinberger A, Kopylov U, Levine A, Maharshak N. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial. J Crohns Colitis. 2022 Mar 14;16(3):369-378. doi: 10.1093/ecco-jcc/jjab165.
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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.
Arie Levine, MD principal investigator
Wolfson Medical Center
Yona Avni, MD principal investigator
Wolfson Medical Center
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal transplantation, Unique novel Diet for UC and Unique novel Diet for the donor + FMT and Unique novel Diet for UC in people with Ulcerative Colitis, run by Wolfson Medical Center at 5 sites in 3 countries.
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 7 inclusion and 23 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, Italy, 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. 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: DSMB recommendation of stopping the trial after reviewing the interim data). 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?
Clinical remission (time frame: Day 56). 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 NCT02734589, 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 1 Jun 2022.