Autism Spectrum DisordersIP-ASDNCT07032857
Intestinal Permeability in Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorders, run by University of Bari at 1 site in Italy.
Trial summary
In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Sep 2025
- Phase
- Observational
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.
Who may be able to join
None listed.
Who cannot join
- Known neurological disorders.
- Major congenital anomalies.
- Severe head trauma.
- Chronic gastrointestinal diseases.
- Special diets (e.g., gluten-free or gluten/casein-free).
- Antibiotic or probiotic/prebiotic intake in the previous 4 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Of Bari Aldo Moro
Bari, BA, 70126
Ruggiero Francavilla, Prof, 00390805592063, rfrancavilla@gmail.com
Fernanda Cristofori, MD, 3384176598, fernandacristofori@gmail.com
About this study
Official title: Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder
In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability ("leaky gut") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning.
Several studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors.
This project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.
Read the detailed description
Study Objectives
Primary Objective:
- To compare intestinal permeability profiles in children with ASD and their neurotypical siblings, using the La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).
Secondary Objectives:
- To explore the correlations between intestinal permeability markers and behavioral dimensions assessed via ADOS, with particular focus on stereotyped behaviors and communication.
- To assess the presence of intestinal inflammation through fecal calprotectin (FC) measurement.
Study Design Observational, case-control, single-center clinical study involving children with ASD and unaffected siblings. The intra-family design allows for control of shared environmental and genetic factors.
Study Population
ASD Group (cases):
- Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.
- Aged between 2 and 14 years.
Control Group (siblings):
- Unaffected siblings who underwent expert clinical evaluation to exclude neurodevelopmental disorders.
- SCQ score below the risk threshold for ASD.
Experimental Methodology 7.1 Intestinal Permeability Test (IPT)
- Fasting and abstention from NSAIDs/alcohol for at least 72 hours.
- Baseline urine sample collection.
- Oral administration of a sugar cocktail containing:
- Lactulose 5 g
- Mannitol 1 g
- Sucrose 20 g
- Sucralose 1 g
- Collection of all urine passed during the following 6 hours.
- Samples stored at -80°C with sodium azide.
Biochemical Analyses
- Sugar quantification via UPLC-MS/MS (Waters ACQUITY™).
- Use of isotopically labeled internal standards and seven-point calibration curves.
- Calculation of urinary recovery percentages and La/Ma ratio.
- FC measured via ELISA (Calprest®). Behavioral Assessment Tools
- ADOS-G: severity assessment in communication, social interaction, and stereotyped behavior domains.
- SCQ: ASD screening in controls.
- IQ assessed with standardized psychometric tests.
Statistical Analysis
- Descriptive statistics using mean ± SD or median (IQR).
- Shapiro-Wilk test for normality.
- Welch's t-test or Mann-Whitney U test for group comparisons.
- Fisher's exact test for categorical variables.
- Spearman's rank correlation (ρ) for associations between permeability indices and behavioral variables.
Relevance and Future Perspectives This protocol contributes to the growing body of translational research exploring the impact of intestinal function on neurodevelopmental disorders. The potential to identify biomarkers associated with specific behavioral domains may inform future personalized therapeutic strategies, including those targeting the intestinal barrier through prebiotics, probiotics, or anti-inflammatory nutraceuticals.
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism spectrum Disorders, Intestinal permeability, Leaky gut
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autism spectrum disorders | Intestinal Permeability Assessment | |
| Sibilings | Intestinal Permenability Assessmnt |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal permeability
La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jan 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032857
- Sponsor's protocol ID
- IP-ASD
- Acronym
- IP-ASD
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07032857
- Acronym / sponsor ID
- IP-ASD / IP-ASD
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism spectrum Disorders, Intestinal permeability, Leaky gut
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Jun 2025 (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.
In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability ("leaky gut") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning.
Several studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors.
This project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.
Detailed description
Study Objectives
Primary Objective:
- To compare intestinal permeability profiles in children with ASD and their neurotypical siblings, using the La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).
Secondary Objectives:
- To explore the correlations between intestinal permeability markers and behavioral dimensions assessed via ADOS, with particular focus on stereotyped behaviors and communication.
- To assess the presence of intestinal inflammation through fecal calprotectin (FC) measurement.
Study Design Observational, case-control, single-center clinical study involving children with ASD and unaffected siblings. The intra-family design allows for control of shared environmental and genetic factors.
Study Population
ASD Group (cases):
- Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.
- Aged between 2 and 14 years.
Control Group (siblings):
- Unaffected siblings who underwent expert clinical evaluation to exclude neurodevelopmental disorders.
- SCQ score below the risk threshold for ASD.
Experimental Methodology 7.1 Intestinal Permeability Test (IPT)
- Fasting and abstention from NSAIDs/alcohol for at least 72 hours.
- Baseline urine sample collection.
- Oral administration of a sugar cocktail containing:
- Lactulose 5 g
- Mannitol 1 g
- Sucrose 20 g
- Sucralose 1 g
- Collection of all urine passed during the following 6 hours.
- Samples stored at -80°C with sodium azide.
Biochemical Analyses
- Sugar quantification via UPLC-MS/MS (Waters ACQUITY™).
- Use of isotopically labeled internal standards and seven-point calibration curves.
- Calculation of urinary recovery percentages and La/Ma ratio.
- FC measured via ELISA (Calprest®). Behavioral Assessment Tools
- ADOS-G: severity assessment in communication, social interaction, and stereotyped behavior domains.
- SCQ: ASD screening in controls.
- IQ assessed with standardized psychometric tests.
Statistical Analysis
- Descriptive statistics using mean ± SD or median (IQR).
- Shapiro-Wilk test for normality.
- Welch's t-test or Mann-Whitney U test for group comparisons.
- Fisher's exact test for categorical variables.
- Spearman's rank correlation (ρ) for associations between permeability indices and behavioral variables.
Relevance and Future Perspectives This protocol contributes to the growing body of translational research exploring the impact of intestinal function on neurodevelopmental disorders. The potential to identify biomarkers associated with specific behavioral domains may inform future personalized therapeutic strategies, including those targeting the intestinal barrier through prebiotics, probiotics, or anti-inflammatory nutraceuticals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism spectrum disorders | – | –Intestinal Permeability Assessment |
| Sibilings | – | –Intestinal Permenability Assessmnt |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Known neurological disorders.
- Major congenital anomalies.
- Severe head trauma.
- Chronic gastrointestinal diseases.
- Special diets (e.g., gluten-free or gluten/casein-free).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intestinal permeability
Time frame: baseline
La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).
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 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Autism Spectrum Disorders, run by University of Bari at 1 site in Italy.
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 0 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. 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 Italy. 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. 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 Ruggiero Francavilla, Prof (00390805592063, rfrancavilla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal permeability (time frame: baseline). 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 Jun 2025.