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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Fecal transplantation administered orally via frozen capsules.
Placebo capsules
Assaf-HarofehMC
Ẕerifin, Israel
RECRUITINGUC remission
UC remission at week 12 defined as a Simple Clinical Colitis Activity Index\<3
Time frame: 12 weeks
Improvement in UC symptoms
defined as improvement in SCCAI
Time frame: 12 weeks
markers of inflammation
Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin
Time frame: 12 weeks, 6 months and 12 months
Improvement in UC endoscopic score
Mayo-score
Time frame: 12 weeks, 6 months and 12 months
change in gut microbiome
Diversity and variability of gut microbiome
Time frame: 12 weeks, 6 and 12 months.
use of treatments for UC
such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.
Time frame: 6+12 months
Extra-intestinal disease manifestations
Extra-intestinal disease manifestations
Time frame: 6 and 12 month
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