Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

Study Purpose

To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 16 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of >10 and ≤40, and SES-CD of >3); agree to received regularly colonoscopy.

Exclusion Criteria:

patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05321758
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tongji Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhihua Huang
Principal Investigator Affiliation	Tongji Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease

Additional Details

Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active Crohn's disease (CD) in children. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN alone served as the PEN group. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 3 courses, 3 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3 times of FMT treatment for each course. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

Arms & Interventions

Arms

Active Comparator: FMT group

Repeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 3 courses, 3 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3 times of FMT treatment for each course.

Sham Comparator: PEN group

Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention

Interventions

Biological: - Fecal Microbiota Transplantation

In the induction stage of CD, FMT was given 3 courses, 3 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3 times of FMT treatment for each course

Other: - PEN

PEN

Contact a Trial Team

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International Sites

Tongji Hospital, Wuhan, Hubei, China

Status

Recruiting

Address

Tongji Hospital

Wuhan, Hubei, 430030

Site Contact

Biao Zou

464021552@qq.com

15871365900

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