Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients
- Conditions
- Ulcerative Colitis
- Interventions
- Other: Fecal transplantationOther: Placebo
- Registration Number
- NCT03582969
- Lead Sponsor
- Assaf-Harofeh Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Patients newly diagnosed (>9 months) with mild to moderate ulcerative colitis as per colonic biopsy and clinical disease activity (SCCAI 5-12).
- Patients not started on immune-suppressive or anti-inflammatory medications (Mesalamine is allowed).
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
- Ability to understand and the willingness to sign a written document, including the willingness to accept risk of unrelated donor stool.
- Ability of parents or other legal guardian to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
- Ability to swallow oral medications.
- Severe, uncontrolled ulcerative colitis.
- At time of enrollment, immune-suppressive or anti-inflammatory medications, except Mesalamine.
- Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Delayed gastric emptying syndrome
- Known chronic aspiration
- Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
- Pregnant and breast-feeding women
- Participants who are unable to swallow pills.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fecal transplantation Fecal transplantation Fecal transplantation of feces from healthy donor via capsules. Oral application. Placebo Placebo Placebo capsules
- Primary Outcome Measures
Name Time Method UC remission 12 weeks UC remission at week 12 defined as a Simple Clinical Colitis Activity Index\<3
- Secondary Outcome Measures
Name Time Method Improvement in UC symptoms 12 weeks defined as improvement in SCCAI
Improvement in UC endoscopic score 12 weeks, 6 months and 12 months Mayo-score
use of treatments for UC 6+12 months such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.
markers of inflammation 12 weeks, 6 months and 12 months Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin
Extra-intestinal disease manifestations 6 and 12 month Extra-intestinal disease manifestations
change in gut microbiome 12 weeks, 6 and 12 months. Diversity and variability of gut microbiome
Trial Locations
- Locations (1)
Assaf-HarofehMC
🇮🇱Zerifin, Israel