Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients (FMT UC)
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|ClinicalTrials.gov Identifier: NCT03582969|
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis.
This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed pediatric patients with mild-moderate UC.
The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation, in newly diagnosed pediatric patients with mild-moderate UC.
All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: Fecal transplantation Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a placebo-controlled, double blinded interventional study evaluating oral, fecal microbiota transplantation, administered in patients with mild-moderate UC.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||The placebo capsules are blocked capsules containing a mixture of saline and glycerine, identical in appearance and consistency to the FMT capsules.|
|Official Title:||High Intensity, Multi-Donor, Oral Capsulized Fecal Microbiota Transplantation in Newly Diagnosed Pediatric Patients With Mild to Moderate Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: Fecal transplantation
Fecal transplantation of feces from healthy donor via capsules. Oral application.
Other: Fecal transplantation
Fecal transplantation administered orally via frozen capsules.
Placebo Comparator: Placebo
- UC remission [ Time Frame: 12 weeks ]UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3
- Improvement in UC symptoms [ Time Frame: 12 weeks ]defined as improvement in SCCAI
- markers of inflammation [ Time Frame: 12 weeks, 6 months and 12 months ]Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin
- Improvement in UC endoscopic score [ Time Frame: 12 weeks, 6 months and 12 months ]Mayo-score
- change in gut microbiome [ Time Frame: 12 weeks, 6 and 12 months. ]Diversity and variability of gut microbiome
- use of treatments for UC [ Time Frame: 6+12 months ]such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.
- Extra-intestinal disease manifestations [ Time Frame: 6 and 12 month ]Extra-intestinal disease manifestations
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): NCT03582969
|Contact: Ilan Youngster, MDfirstname.lastname@example.org|
|Contact: Nirit Keren, PhDemail@example.com|
|Zerifin, Israel, 70300|
|Contact: Ilan Youngster, Dr. 972-50-6301191 firstname.lastname@example.org|