Pilot Study of Fecal Transplantation Using a Unique Diet for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT02734589|
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: Fecal transplantation Other: Unique novel Diet for UC and Unique novel Diet for the donor + FMT Other: Unique novel Diet for UC||Not Applicable|
The first exploratory phase will take place in 34 subjects aged 18-60, with refractory established UC, over 12 weeks. 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. Should the first stage be successful, The investigators will continue the fecal transplantation trial to reach our target enrolment number ( 76 patients) for transplantation + 20 dietary controls. This second stage of the study will involve fecal transplantation in an additional 52 patients in order to have a total of 76 transplanted patients from the two phases.
since physicians will be able to distinguish between stool and colored saline during colonoscopy.
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 commence 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.
Open Label treatment of refractory patients:
Patients in group 1 and 3 who do not improve by week 8 ( day 56) may be treated with the identical protocol used in Group 2 at the physicians discretion or receive any other therapy. These patients will be seen at day 14 and 56 as above, and have the same monitoring of dietary compliance by food diaries at days 14 and 56 and biological samples as above. 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fecal Transplantation Using a Novel Conditioning Method for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease|
|Actual Study Start Date :||January 24, 2017|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Fecal microbiota transplantation (FMT) without Diet
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.
Other: Fecal transplantation
Transplantation of fecal bacteria from a healthy individual into a recipient- ulcerative colitis patient via colonoscopy and enemas
Other Name: Fecal microbiota transplantation (FMT)
Experimental: FMT with Diet for the donor and for the recipient
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.
Other: Unique novel Diet for UC and Unique novel Diet for the donor + FMT
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.
Other Name: Ulcerative Colitis Diet (UCD) and the conditioning diet
Active Comparator: Dietary therapy only
The patient will receive detailed instructions regarding the UC diet to be used over 12 weeks without FMT.
Other: Unique novel Diet for UC
A developed diet that is geared to induces remission and decreases inflammation in patients with active UC.
Other Name: Ulcerative Colitis Diet (UCD)
- Clinical remission determined by Simple Clinical Colitis Activity Index (SCCAI) score <5 at week 8 for group 1 and 2 [ Time Frame: Day 56 ]
- Improvement in the Simple Clinical Colitis Activity Index (SCCAI) score for each of the groups [ Time Frame: Days 56 & 84 ]
- Endoscopic Mayo endoscopic score <2 (for patients performing sigmoidoscopy) [ Time Frame: Day 56 ]
- Calprotectin < 250 µg/g [ Time Frame: Day 56 ]
- The need for additional therapy [ Time Frame: Week 12 ]According to the physician discretion
- change in the microbiome compared to baseline. [ Time Frame: For donor- day 14 and for recipient day 56 ]According to analysis of fecal samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734589
|Contact: Arie Levine, MDemail@example.com|
|Contact: Chen Sarbagilifirstname.lastname@example.org|
|Saint-Antoine Hospital, Universite Pierre et Marie Curie||Not yet recruiting|
|Paris, France, 75571|
|Contact: Harry Sokol, MD +330149283162 email@example.com|
|Principal Investigator: Harry Sokol, MD|
|Wolfson Medical Center||Recruiting|
|Holon, Israel, 58100|
|Contact: Arie Levine, MD 972 35028838 firstname.lastname@example.org|
|Contact: Chen Sarbagili 972 35028838 email@example.com|
|Principal Investigator: Arie Levine, MD|
|Tel Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel|
|Contact: Nitsan Maharshak, MD 972-36947305 firstname.lastname@example.org|
|Principal Investigator: Iris Dotan, MD|
|Principal Investigator: Nitsan Maharshak, MD|
|Humanitas Clinical and Research Center||Not yet recruiting|
|Contact: Silivio Danese, MD, PhD email@example.com|
|Principal Investigator: Silivio Danese, MD, PhD|
|Catholic University of the Secret Heart||Not yet recruiting|
|Contact: Franco Scaldaferri, MD +390630155923 firstname.lastname@example.org|
|Principal Investigator: Franco Scaldaferri, MD|
|Principal Investigator:||Arie Levine, MD||Wolfson Medical Center|
|Principal Investigator:||Yona Avni, MD||Wolfson Medical Center|