ClinicalTrials.gg
Sign In
RecruitingNCT07032857IP-ASDUpdated Jun 27, 2025

Intestinal Permeability in Children With Autism Spectrum Disorder

An observational study in Autism Spectrum Disorders, sponsored by University of Bari. Recruiting at 1 site in Italy. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by University of Bari · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
55
Ages
2 Years to 14 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Autism Spectrum Disorders

Keywords

  • autism spectrum Disorders
  • Intestinal permeability
  • Leaky gut
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's planned enrollment of 55 is below the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

University of Bari is the lead sponsor of 76 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.

Eligibility criteria

  • Children with a clinical diagnosis of ASD according to , confirmed by ADOS-G.
  • Consumption of a gluten-containing diet.
  • Negative celiac disease serology (EMA and anti-TG2 IgA antibodies).
  • Absence of IgE- or non-IgE-mediated food allergies.

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
55 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Autism spectrum disorders

    Intestinal Permeability Assessment

  • Sibilings

    Intestinal Permenability Assessmnt

06

What researchers measure

Primary outcomes

  1. intestinal permeability

    La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Sep 2025, 32 months after the start.

Of 98 non-industry observational studies under Autism Spectrum Disorder, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 120. This study's planned 32 months is below that.

Counting every sponsor, half of 112 studies reached it within 40 months; a quarter within 26 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2025
First posted
Jun 24, 2025
StartActual
Jan 1, 2023
Primary completionEst.
Sep 30, 2025
CompletionEst.
Sep 30, 2025
Last update
Jun 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07032857
Lead sponsor
University of Bari
Responsible party
Ruggiero Francavilla (Prof, University of Bari) — Principal investigator
First posted
Jun 24, 2025
Start date
Jan 1, 2023
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jun 27, 2025

Study contacts

Ruggiero Francavilla, Prof
Contact
rfrancavilla@gmail.com
00390805592063
fernanda Cristofori, MD
Contact
fernandacristofori@gmail.com
00393384176598

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Autism Spectrum Disorder →

Other studies from this sponsor

University of Bari

Start the discussion