Health TrialsbyHealthPanel

Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

ConditionUlcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-16
SponsorBiao Zou

About this trial

This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Fecal Microbiota Transplantation

    Other intervention

    In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT group are given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: FMT groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

clinical response

reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline

Time frame
8-12 weeks after FMT
2

clinical remission

Clinical remission defined as a PUCAI \<10

Time frame
8-12 weeks after FMT
3

safety of FMT

All possible adverse events: fever, abdominal pain, infectious diseases and others.

Time frame
8-12 weeks after FMT

Secondary outcomes

1

Number of patients requiring escalation of medical therapies

Number of patients requiring escalation of medical therapies based on clinical relapse. Clinical relapse is defined by requiring additional medical therapy.

Time frame
8-12 weeks after FMT
2

Number of patients with endoscopic remission

Number of patients with endoscopic remission as defined by a PUCAI score of 0

Time frame
8-12 weeks after FMT
3

Fecal calprotectin level

Mean change of Fecal calprotectin levels

Time frame
8-12 weeks after FMT
4

C-reactive protein levels

Mean change of C-reactive protein levels

Time frame
8-12 weeks after FMT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biao Zou

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now