Blood-brain barrier and intestinal epithelial barrier alterations in autism spectrum disorders.
Maria Fiorentino, Anna Sapone, Stefania Senger...
https://pubmed.ncbi.nlm.nih.gov/27957319/Actively Recruiting
Led by McMaster Children's Hospital · Updated on 2025-08-21
20
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating a new protocol of Fecal Microbiota Transplantation FMT to treat pediatric small intestinal bacterial overgrowth SIBO, focusing on children aged 3 to 18 years with intestinal resection. The study aims to assess the feasibility, safety, and short- and long-term clinical effectiveness of FMT in managing SIBO, a condition that can cause malabsorption, bloating, infections, and acidosis, especially in children with short bowel syndrome SBS. Participants will receive a single FMT infusion of about 50 grams of screened human stool prepared according to institutional standards. The infusion is administered via the childs existing enteral feeding tube or by elective upper endoscopy into the duodenum. Patients will stop antibiotics at least one week prior to FMT and will be monitored at one, four, and eight weeks after treatment. This open-label trial does not include randomization or placebo controls. Throughout the study, participants will undergo clinical symptom scoring, lactose breath testing, and biological sample collection including blood, stool, and urine at baseline and post-FMT timepoints. Researchers will track symptom changes, remission rates, microbial composition, and metabolic markers to evaluate treatment impact. Safety, acceptability, and recruitment rates will also be measured, with follow-up care coordinated through local institutions. The total participation spans eight weeks post-treatment.
CONDITIONS
Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth
F
Fariha Chowdhury, BASc, MSc, PhD(c)
N
Nikhil Pai, BSc, MD, CNSC, FRCPC, FAAP
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McMaster Children's Hospital
Lead Sponsor
The Hospital for Sick Children
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive one fecal microbiota transplant infusion via existing enteral feeding tubes or upper endoscopy into the duodenum.
1 treatment visit (in-person)
Duration - 8 weeks
Participants are monitored at one, four, and eight weeks after the transplant to assess symptoms, collect clinical samples, and track safety and efficacy.
3 follow-up visits (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor
The Hospital for Sick Children
Collaborating Sponsor