The aim of the study is to evaluate the effectiveness and safety of fecal microbiota transplantation (FMT) in reducing gastrointestinal (GI) and behavioral symptoms in children with autism spectrum disorder (ASD).
Children with ASD often experience GI problems such as constipation, diarrhea, and abdominal pain. These symptoms can negatively affect their daily life and behavior. Recent research suggests that the gut microbiota-the community of bacteria and other microorganisms living in the intestines-plays an important role in digestion, immunity, and communication with the brain through the gut-brain axis. Modifying the gut microbiota may help improve GI symptoms and possibly behavioral functioning.
FMT involves giving a preparation containing gut microbiota from a healthy donor after bowel cleansing. The product used in this study is MBiotix HBI Caps, produced by Human Biome Institute. A placebo (inactive substance) will also be used for comparison. Both will be given as frozen oral capsules that look identical.
20 children aged 6-12 years will take part. Participants will be randomly assigned to receive either the microbiota preparation or placebo. The study includes several visits over about 6 months. Before the first dose, every child will undergo bowel cleansing with a special preparation (Polyethylene Glycol, PEG). During the study, participants will be asked to keep a symptom diary, complete questionnaires, and record child's diet. Biological samples (stool, urine, saliva) will be collected at specific time points for analysis. Every child will also be assessed by a psychologist before the study begins and again during the study using standardized tools (Autism Diagnostic Observation Schedule, Second Edition, ADOS-2) to evaluate behavioral functioning and quality of life.
Providing informed consent for participation in the study by the child's legal representative - parent or legal guardian.
Diagnosis of autism spectrum disorder according to DSM-5 or ICD-11 criteria.
Ability to swallow an empty test capsule identical in shape and size to the investigational product
Abnormal stool consistency observed by parents for at least 2 months prior to study inclusion.
Presence of a gastrointestinal disease such as celiac disease, food allergy, inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease of the stomach or duodenum, Hirschsprung's disease.
Primary or secondary immunodeficiency, including absolute neutrophil count in peripheral blood <1500 measured within 28 days prior to planned FMT.
History of surgery involving disruption of intestinal continuity within 3 months prior to study inclusion.
Lactose or fructose intolerance. Patients with lactose intolerance who follow an elimination diet and still experience symptoms may be included in the study.
Parallel
MBiotix® HBI Caps
Other interventionMBiotix HBI Caps (Human Biome Institute, Poland) are enteric-coated capsules containing a concentrated suspension of gut microbiota obtained by centrifugation of a solution prepared from 60 g of donor stool suspended in 200 ml of 0.9% NaCl and glycerol. Each capsule set contains approximately 10¹³ viable bacterial cells. Dosing depends on body weight: Children weighing \*\*\>35 kg\*\* will receive 60 g at visit 1 and 30 g at visits 2 (after 4 weeks) and 3 (after 8 weeks). Children weighing \*\*\<35 kg\*\* will receive 30 g at visit 1 and 15 g at visits 2 (after 4 weeks) and 3 (after 8 weeks).
Placebo
Other interventionPlacebo
Number of patients who showed an improvement in stool consistency by at least 1 point on the Bristol Stool Scale compared to the baseline period.
The average stool consistency will be calculated from the one-week baseline period and from weekly observation periods during the study.
Bowel movements
Change in the number of bowel movements compared to the baseline period.
Abdominal pain episodes
Change in the number of abdominal pain episodes compared to the baseline period.
Days with abdominal pain
Change in the number of days with abdominal pain compared to the baseline period. Endpoints assessing abdominal pain will be evaluated only in children who are able to communicate their symptoms.
Excessive gas
Change in the number of days with excessive gas according to parent's assessment.
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Institute of Mother and Child, Warsaw, Poland
Lead sponsor
Human Biome Institute S.A.
Collaborator
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