Autism Spectrum DisorderFMT-ASD-GINCT07371013
Fecal Microbiota Transplantation in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms
A study testing MBiotix® HBI Caps in people with Autism Spectrum Disorder and Gastrointestinal Symptoms, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Gastrointestinal Symptoms
- What is being tested?
- MBiotix® HBI Caps
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Patients with an average stool consistency greater than 5 on the Bristol Stool Form Scale (BSFS) during the baseline period will be classified as having diarrhea.
- Patients with an average stool consistency less than 3 on the Bristol Stool Form Scale during the baseline period will be classified as having constipation.
Who cannot join
- 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.
- Malnutrition defined as Body Mass Index (BMI) below the 3rd percentile based on Polish growth charts from 2010.
- Overweight or obesity defined as BMI above the 85th percentile based on Polish growth charts from 2010.
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- Active infection requiring antibiotic therapy.
- Expected use of antibiotics during participation in the study.
- Use of probiotics during participation in the study.
- Inability to undergo bowel cleansing therapy (Dicopeg Endo).
- Inability to swallow an empty test capsule.
- Lack of consent from the child's legal representative - parent or legal guardian - for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Institute of Mother and Child
Warsaw, Masovian Voivodeship, 01-211
About this study
Official title: Fecal Microbiota Transplantation in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms: A Pilot Study
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.
Read more
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.
- Being tested
- MBiotix® HBI Caps, Placebo
- Keywords
- fmt, asd, gi, autism
- Medical subject headings
- Autism Spectrum Disorder, Child Development Disorders, Pervasive, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBiotix® HBI CapsOther
MBiotix 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).
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MBiotix® HBI Caps | Experimental | Not described Receives: Other: MBiotix® HBI Caps |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4,8,9,12,26,20 weeks
Secondary outcomes (15)
Bowel movements
Change in the number of bowel movements compared to the baseline period.
Measured: 4,8,9,12,16,20 weeks
Abdominal pain episodes
Change in the number of abdominal pain episodes compared to the baseline period.
Measured: 4,8,9,12,16,20 weeks
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.
Measured: 4,8,9,12,16,20 weeks
Excessive gas
Change in the number of days with excessive gas according to parent's assessment.
Measured: 4,8,9,12,16,20 weeks
Regurgitation
Change in the number of days with regurgitation compared to the baseline period.
Measured: 4,8,9,12,16,20 weeks
Vomiting
Change in the number of days with vomiting compared to the baseline period.
Measured: 4,8,9,12,16,20 weeks
Child absence
Change in the number of days absent from kindergarten or school due to symptoms.
Measured: 4,8,9,12,16,20 weeks
Parent's work absence
Change in the number of days of parental or caregiver work absence due to symptoms
Measured: 4,8,9,12,16,20 weeks
Adverse events
Adverse events reported by children and parents, recorded in the symptom diary and reported to the physician.
Measured: 0,4,8,9,12,16,20 weeks
SRS-2
Change in the score of the psychological test Social Responsiveness Scale-2 (SRS-2) compared to baseline.
Measured: 9,20 weeks
ASRS
Change in the score of the psychological test Autism Spectrum Rating Scales (ASRS) compared to baseline
Measured: 9,20 weeks
ADOS-2
Change in the score of the psychological test Autism Diagnostic Observation Schedule-2 (ADOS-2) compared to baseline.
Measured: 9,20 weeks
CBCL
Change in the score of the psychological test Child Behavior Checklist (CBCL) compared to baseline.
Measured: 9,20 weeks
ABAS-3
Change in the score of the psychological test Adaptive Behavior Assessment System-3 (ABAS-3) compared to baseline.
Measured: 9,20 weeks
QoLA
Change in parental quality of life assessed using the Quality of Life in Autism Questionnaire (QoLA) compared to baseline.
Measured: 9,20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, placebo-controlled, pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mother and Child, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Human Biome S.A.
- Responsible party
- Principal investigator, dr n.med. Anna Liber, Institute of Mother and Child, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371013
- Sponsor's protocol ID
- 12/2025
- Acronym
- FMT-ASD-GI
- Status last verified
- Dec 2025
- First submitted
- 12 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms: A Pilot Study
- ClinicalTrials.gov ID
- NCT07371013
- Acronym / sponsor ID
- FMT-ASD-GI / 12/2025
- Keywords
- fmt, asd, gi, autism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Mother and Child, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Human Biome S.A.
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, placebo-controlled, pilot study
| Arm | Type | Receives |
|---|---|---|
| MBiotix® HBI Caps | Experimental | Other: MBiotix® HBI Caps |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
- Patients with an average stool consistency greater than 5 on the Bristol Stool Form Scale (BSFS) during the baseline period will be classified as having diarrhea.
Key exclusion criteria (12 listed)
- 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.
- Malnutrition defined as Body Mass Index (BMI) below the 3rd percentile based on Polish growth charts from 2010.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBiotix® HBI CapsMBiotix 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). | Other | MBiotix® HBI Caps |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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.
Time frame: 4,8,9,12,26,20 weeks
The average stool consistency will be calculated from the one-week baseline period and from weekly observation periods during the study.
15 secondary outcomes
Bowel movements
Time frame: 4,8,9,12,16,20 weeks
Abdominal pain episodes
Time frame: 4,8,9,12,16,20 weeks
Days with abdominal pain
Time frame: 4,8,9,12,16,20 weeks
Excessive gas
Time frame: 4,8,9,12,16,20 weeks
Regurgitation
Time frame: 4,8,9,12,16,20 weeks
Vomiting
Time frame: 4,8,9,12,16,20 weeks
Child absence
Time frame: 4,8,9,12,16,20 weeks
Parent's work absence
Time frame: 4,8,9,12,16,20 weeks
Adverse events
Time frame: 0,4,8,9,12,16,20 weeks
SRS-2
Time frame: 9,20 weeks
ASRS
Time frame: 9,20 weeks
ADOS-2
Time frame: 9,20 weeks
CBCL
Time frame: 9,20 weeks
ABAS-3
Time frame: 9,20 weeks
QoLA
Time frame: 9,20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBiotix® HBI Caps in people with Autism Spectrum Disorder and Gastrointestinal Symptoms, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Liber (+48 223277234, anna.liber@imid.med.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4,8,9,12,26,20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.