Autism Spectrum DisorderNCT07086157
Low-FODMAP Diet and Probiotics: Effects on Gut, Behavior, and Microbiota in Children With Autism Spectrum Disorder
A study testing Probiotic and Low-FODMAP Diet in people with Autism Spectrum Disorder and Functional Gastrointestinal Disorders, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to evaluate whether a low-FODMAP diet and probiotic supplements could reduce gastrointestinal (GI) symptoms and behavior problems in children with autism spectrum disorder (ASD) who also experienced GI issues. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Functional Gastrointestinal Disorders
- What is being tested?
- Probiotic and Low-FODMAP Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosed with Autism Spectrum Disorder by a specialist at Marmara University Pendik Training and Research Hospital Child and Adolescent Psychiatry Clinic
- Aged between 6 and 12 years
- Diagnosed with functional gastrointestinal symptoms according to Rome IV criteria
- Willing to participate by signing informed consent and assent forms (by both child and parent)
Who cannot join
- Following any other dietary intervention at the time of study initiation
- Routine use of prebiotics or probiotics
- Use of antibiotics within the 4 weeks prior to the study
- Presence of active diarrhea due to intestinal infection or similar condition
- Diagnosis of other gastrointestinal diseases besides functional GI symptoms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara Univesity Pendik Training and Research Hospital
Istanbul
About this study
Official title: Effects of Low-FODMAP Diet and Probiotics on Gastrointestinal Symptoms, Behavior Problems, and Microbiota in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms
The goal of this clinical trial was to evaluate whether a low-FODMAP diet and probiotic supplements could reduce gastrointestinal (GI) symptoms and behavior problems in children with autism spectrum disorder (ASD) who also experienced GI issues. The main questions it aimed to answer were:
Did a low-FODMAP diet and/or probiotics improve GI symptoms such as constipation, diarrhea, and abdominal pain?
Read more
Did these interventions help reduce behavior problems such as irritability, lethargy, stereotypy, hyperactivity, and speech disorder ?
Researchers compared two groups:
- Children who received a daily probiotic supplement containing 4 strains for 4 weeks
- Children who received both the probiotic supplement and followed a low-FODMAP diet
This comparison aimed to determine whether the combination of diet and probiotics had greater benefits than probiotics alone.
Participants:
Took the assigned intervention(s) for 4 weeks
Provided stool samples for gut microbiota analysis
Completed assessments of GI symptoms and behavior using validated questionnaires
Read the detailed description
This randomized, controlled, parallel-group clinical trial aimed to investigate the effects of a low-FODMAP diet and multi-strain probiotic supplementation on gastrointestinal (GI) symptoms, behavioral problems, and gut microbiota composition in children with Autism Spectrum Disorder (ASD) who presented with concurrent GI complaints.
Children aged 6 to 12 years with clinically diagnosed ASD and GI symptoms were recruited. A total of 16 participants were randomly assigned into two equal groups (n=8 per group). One group received a probiotic supplement containing four bacterial strains daily for 4 weeks, while the second group received the same probiotic supplement in combination with a low-FODMAP diet over the same period. The randomization was stratified and allocation was blinded to the data analysts.
Interventions Probiotic group: A commercially available probiotic blend (containing Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus rhamnosus, and Saccharomyces boulardii) was administered once daily for 4 weeks.
Low-FODMAP + Probiotic group: In addition to the probiotic supplement, participants received individualized nutrition counseling and followed a standardized low-FODMAP diet protocol under dietitian supervision for 4 weeks.
Data Collection and Measures GI symptoms were assessed using the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III Version (QPGS-RIII) and the Bristol Stool Scale (BSS).
Behavioral outcomes were evaluated using the Aberrant Behavior Checklist (ABC), focusing on subscales including irritability, lethargy-social withdrawal, stereotypy, hyperactivity, and inappropriate speech.
Dietary intake was recorded using 3-day food diaries to determine intake of daily FODMAP amount.
Microbiota composition was analyzed from fecal samples using 16S rRNA gene sequencing and LEfSe (Linear Discriminant Analysis Effect Size) for taxonomic biomarker discovery.
Quality Control and Data Validation All participants were monitored weekly to ensure adherence to interventions and assess adverse effects.
Dietary intake data were validated against food portion models and caregiver interviews.
Stool sample processing followed standardized protocols: DNA was extracted, amplified, and sequenced using Illumina platforms.
A pre-defined bioinformatics pipeline was used for quality filtering, taxonomic assignment, and alpha/beta diversity analysis.
Internal consistency checks and double data entry validation were applied to all behavioral and symptom questionnaires.
Statistical Analysis Statistical analysis was performed using SPSS v25 and R. Paired and independent-sample t-tests or Wilcoxon signed-rank tests were applied based on distribution normality. Microbiota diversity indices (Shannon, Simpson, Chao1) and taxonomic differences were compared across groups and time points. Spearman correlation analyses were used to explore associations between microbiota shifts and clinical parameters. A p-value of <0.05 was considered statistically significant.
- Being tested
- Probiotic, Low-FODMAP Diet
- Keywords
- autism spectrum disorder, probiotics, gut microbiota, low FODMAP diet, gastrointestinal symptoms
- Medical subject headings
- Autism Spectrum Disorder, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
A probiotic supplement in capsule form containing 4 strains of microorganisms, with a total of 10 × 10⁹ CFU (colony-forming units) per capsule. The strain composition per capsule was:
Lactobacillus acidophilus L1 - 2.9 × 10⁹ CFU, Bifidobacterium longum LBL-01 - 2.9 × 10⁹ CFU, Lactobacillus rhamnosus - 2.9 × 10⁹ CFU, Saccharomyces boulardii - 1.3 × 10⁹ CFU. Each participant in this arm took one capsule per day in the morning on a full stomach, for a duration of 4 weeks. No other dietary interventions were applied to this group. This probiotic supplement was chosen because the strains in its content are among the most frequently researched and known strains in terms of intestinal health. Additionally, it does not contain FOS or inulin due to FODMAP restriction.
.
Low-FODMAP DietOther
A structured low-FODMAP diet intervention designed to restrict intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. The diet was individualized and monitored by a registered dietitian over a 4-week period to ensure adherence and nutritional adequacy.
| Study group | Role | What they receive |
|---|---|---|
| Low-FODMAP Diet + Probiotic Supplement | Experimental | Participants in this arm received the same probiotic supplement as the other group once daily for 4 weeks, in combination with a personalized low-FODMAP diet. The diet was planned and monitored by a registered dietitian to ensure compliance and nutritional adequacy. Receives: Dietary Supplement: Probiotic; Other: Low-FODMAP Diet |
| Probiotic Supplement Only | Experimental | Participants in this arm received a multi-strain probiotic supplement containing four bacterial strains (Lactobacillus acidophilus L1, Bifidobacterium longum LBL-01, Lactobacillus rhamnosus, and Saccharomyces boulardii) once daily for 4 weeks. No dietary restrictions or modifications were applied in this group. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
Change in caregiver-reported irritability scores as measured by the Aberrant Behavior Checklist Irritability Subscale, a standardized behavioral rating scale.
Measured: Baseline and after 4 weeks of intervention
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score
Change in hyperactivity scores, as assessed by the caregiver-completed Hyperactivity Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Measured: Baseline and after 4 weeks of intervention
Change in Aberrant Behavior Checklist (ABC) Lethargy-Social Withdrawal Subscale Score
Change in lethargy-social withdrawal scores, as assessed by the caregiver-completed Lethargy-Social Withdrawal Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Measured: Baseline and after 4 weeks of intervention
Change in Aberrant Behavior Checklist (ABC) Stereotypy Subscale Score
Change in stereotypy scores, as assessed by the caregiver-completed Stereotypy Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Measured: Baseline and after 4 weeks of intervention
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
Change in inappropriate speech scores, as assessed by the caregiver-completed Inappropriate Speech Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Measured: Baseline and after 4 weeks of intervention
Change in Presence of Functional Gastrointestinal Symptoms as Measured by the QPGS-RIII
Change in the presence of any functional gastrointestinal symptoms as determined by caregiver responses to the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III (QPGS-RIII), a validated diagnostic tool for functional gastrointestinal disorders in children.
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (3)
Change in Gut Microbiota Alpha Diversity (Shannon Index)
Change in microbial alpha diversity of stool samples, assessed using 16S rRNA gene sequencing and expressed as the Shannon diversity index.
Measured: Baseline and after 4 weeks of intervention
Change in Gut Microbiota Beta Diversity (UniFrac Analysis)
Change in microbial beta diversity of stool samples, assessed using 16S rRNA gene sequencing and analyzed with UniFrac distance metrics to evaluate differences in microbial community composition between samples.
Measured: Baseline and after 4 weeks of intervention
Change in Relative Abundance of Specific Bacterial Genera
Change in the relative abundance (%) of key bacterial genera identified through 16S rRNA sequencing and LEfSe analysis.
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Responsible party
- Principal investigator, Pınar Polat, Marmara University Pendik Training and Research Hospital
- Investigators
- Pınar Polat, PhD, Principal investigator, Marmara University Pendik Training and Research HospitalNeşe Perdahlı Fiş, Prof Dr, Study chair, Marmara University Pendik Training and Research HospitalÖzlem Aytekin, AProf Dr, Study director, Saglik Bilimleri UniversitesiFatih Özbey, Prof Dr, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086157
- Sponsor's protocol ID
- 09.2023.1132
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Lee JC, Chen CM, Sun CK, Tsai IT, Cheng YS, Chiu HJ, Wang MY, Tang YH, Hung KC. The therapeutic effects of probiotics on core and associated behavioral symptoms of autism spectrum disorders: a systematic review and meta-analysis. Child Adolesc Psychiatry Ment Health. 2024 Dec 19;18(1):161. doi: 10.1186/s13034-024-00848-3.
PubMed 39702309Iglesias-Vazquez L, Van Ginkel Riba G, Arija V, Canals J. Composition of Gut Microbiota in Children with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Nutrients. 2020 Mar 17;12(3):792. doi: 10.3390/nu12030792.
PubMed 32192218Srikantha P, Mohajeri MH. The Possible Role of the Microbiota-Gut-Brain-Axis in Autism Spectrum Disorder. Int J Mol Sci. 2019 Apr 29;20(9):2115. doi: 10.3390/ijms20092115.
PubMed 31035684Settanni CR, Bibbo S, Ianiro G, Rinninella E, Cintoni M, Mele MC, Cammarota G, Gasbarrini A. Gastrointestinal involvement of autism spectrum disorder: focus on gut microbiota. Expert Rev Gastroenterol Hepatol. 2021 Jun;15(6):599-622. doi: 10.1080/17474124.2021.1869938. Epub 2021 Jan 5.
PubMed 33356668Socala K, Doboszewska U, Szopa A, Serefko A, Wlodarczyk M, Zielinska A, Poleszak E, Fichna J, Wlaz P. The role of microbiota-gut-brain axis in neuropsychiatric and neurological disorders. Pharmacol Res. 2021 Oct;172:105840. doi: 10.1016/j.phrs.2021.105840. Epub 2021 Aug 24.
PubMed 34450312Martinez-Gonzalez AE, Andreo-Martinez P. The Role of Gut Microbiota in Gastrointestinal Symptoms of Children with ASD. Medicina (Kaunas). 2019 Jul 26;55(8):408. doi: 10.3390/medicina55080408.
PubMed 31357482Leader G, Abberton C, Cunningham S, Gilmartin K, Grudzien M, Higgins E, Joshi L, Whelan S, Mannion A. Gastrointestinal Symptoms in Autism Spectrum Disorder: A Systematic Review. Nutrients. 2022 Apr 1;14(7):1471. doi: 10.3390/nu14071471.
PubMed 35406084
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-FODMAP Diet and Probiotics on Gastrointestinal Symptoms, Behavior Problems, and Microbiota in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT07086157
- Acronym / sponsor ID
- 09.2023.1132
- Keywords
- autism spectrum disorder, probiotics, gut microbiota, low FODMAP diet, gastrointestinal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 Jul 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.
The goal of this clinical trial was to evaluate whether a low-FODMAP diet and probiotic supplements could reduce gastrointestinal (GI) symptoms and behavior problems in children with autism spectrum disorder (ASD) who also experienced GI issues. The main questions it aimed to answer were:
Did a low-FODMAP diet and/or probiotics improve GI symptoms such as constipation, diarrhea, and abdominal pain?
Did these interventions help reduce behavior problems such as irritability, lethargy, stereotypy, hyperactivity, and speech disorder ?
Researchers compared two groups:
- Children who received a daily probiotic supplement containing 4 strains for 4 weeks
- Children who received both the probiotic supplement and followed a low-FODMAP diet
This comparison aimed to determine whether the combination of diet and probiotics had greater benefits than probiotics alone.
Participants:
Took the assigned intervention(s) for 4 weeks
Provided stool samples for gut microbiota analysis
Completed assessments of GI symptoms and behavior using validated questionnaires
Detailed description
This randomized, controlled, parallel-group clinical trial aimed to investigate the effects of a low-FODMAP diet and multi-strain probiotic supplementation on gastrointestinal (GI) symptoms, behavioral problems, and gut microbiota composition in children with Autism Spectrum Disorder (ASD) who presented with concurrent GI complaints.
Children aged 6 to 12 years with clinically diagnosed ASD and GI symptoms were recruited. A total of 16 participants were randomly assigned into two equal groups (n=8 per group). One group received a probiotic supplement containing four bacterial strains daily for 4 weeks, while the second group received the same probiotic supplement in combination with a low-FODMAP diet over the same period. The randomization was stratified and allocation was blinded to the data analysts.
Interventions Probiotic group: A commercially available probiotic blend (containing Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus rhamnosus, and Saccharomyces boulardii) was administered once daily for 4 weeks.
Low-FODMAP + Probiotic group: In addition to the probiotic supplement, participants received individualized nutrition counseling and followed a standardized low-FODMAP diet protocol under dietitian supervision for 4 weeks.
Data Collection and Measures GI symptoms were assessed using the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III Version (QPGS-RIII) and the Bristol Stool Scale (BSS).
Behavioral outcomes were evaluated using the Aberrant Behavior Checklist (ABC), focusing on subscales including irritability, lethargy-social withdrawal, stereotypy, hyperactivity, and inappropriate speech.
Dietary intake was recorded using 3-day food diaries to determine intake of daily FODMAP amount.
Microbiota composition was analyzed from fecal samples using 16S rRNA gene sequencing and LEfSe (Linear Discriminant Analysis Effect Size) for taxonomic biomarker discovery.
Quality Control and Data Validation All participants were monitored weekly to ensure adherence to interventions and assess adverse effects.
Dietary intake data were validated against food portion models and caregiver interviews.
Stool sample processing followed standardized protocols: DNA was extracted, amplified, and sequenced using Illumina platforms.
A pre-defined bioinformatics pipeline was used for quality filtering, taxonomic assignment, and alpha/beta diversity analysis.
Internal consistency checks and double data entry validation were applied to all behavioral and symptom questionnaires.
Statistical Analysis Statistical analysis was performed using SPSS v25 and R. Paired and independent-sample t-tests or Wilcoxon signed-rank tests were applied based on distribution normality. Microbiota diversity indices (Shannon, Simpson, Chao1) and taxonomic differences were compared across groups and time points. Spearman correlation analyses were used to explore associations between microbiota shifts and clinical parameters. A p-value of <0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-FODMAP Diet + Probiotic Supplement | Experimental | Dietary Supplement: Probiotic, Other: Low-FODMAP DietParticipants in this arm received the same probiotic supplement as the other group once daily for 4 weeks, in combination with a personalized low-FODMAP diet. The diet was planned and monitored by a registered dietitian to ensure compliance and nutritional adequacy. |
| Probiotic Supplement Only | Experimental | Dietary Supplement: ProbioticParticipants in this arm received a multi-strain probiotic supplement containing four bacterial strains (Lactobacillus acidophilus L1, Bifidobacterium longum LBL-01, Lactobacillus rhamnosus, and Saccharomyces boulardii) once daily for 4 weeks. No dietary restrictions or modifications were applied in this group. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with Autism Spectrum Disorder by a specialist at Marmara University Pendik Training and Research Hospital Child and Adolescent Psychiatry Clinic
- Aged between 6 and 12 years
- Diagnosed with functional gastrointestinal symptoms according to Rome IV criteria
- Willing to participate by signing informed consent and assent forms (by both child and parent)
Key exclusion criteria (5 listed)
- Following any other dietary intervention at the time of study initiation
- Routine use of prebiotics or probiotics
- Use of antibiotics within the 4 weeks prior to the study
- Presence of active diarrhea due to intestinal infection or similar condition
- Diagnosis of other gastrointestinal diseases besides functional GI symptoms
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 |
|---|---|---|
| ProbioticA probiotic supplement in capsule form containing 4 strains of microorganisms, with a total of 10 × 10⁹ CFU (colony-forming units) per capsule. The strain composition per capsule was: Lactobacillus acidophilus L1 - 2.9 × 10⁹ CFU, Bifidobacterium longum LBL-01 - 2.9 × 10⁹ CFU, Lactobacillus rhamnosus - 2.9 × 10⁹ CFU, Saccharomyces boulardii - 1.3 × 10⁹ CFU. Each participant in this arm took one capsule per day in the morning on a full stomach, for a duration of 4 weeks. No other dietary interventions were applied to this group. This probiotic supplement was chosen because the strains in its content are among the most frequently researched and known strains in terms of intestinal health. Additionally, it does not contain FOS or inulin due to FODMAP restriction. . | Dietary supplement | Low-FODMAP Diet + Probiotic Supplement, Probiotic Supplement Only |
| Low-FODMAP DietA structured low-FODMAP diet intervention designed to restrict intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. The diet was individualized and monitored by a registered dietitian over a 4-week period to ensure adherence and nutritional adequacy. | Other | Low-FODMAP Diet + Probiotic Supplement |
Primary outcome
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
Time frame: Baseline and after 4 weeks of intervention
Change in caregiver-reported irritability scores as measured by the Aberrant Behavior Checklist Irritability Subscale, a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score
Time frame: Baseline and after 4 weeks of intervention
Change in hyperactivity scores, as assessed by the caregiver-completed Hyperactivity Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Lethargy-Social Withdrawal Subscale Score
Time frame: Baseline and after 4 weeks of intervention
Change in lethargy-social withdrawal scores, as assessed by the caregiver-completed Lethargy-Social Withdrawal Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Stereotypy Subscale Score
Time frame: Baseline and after 4 weeks of intervention
Change in stereotypy scores, as assessed by the caregiver-completed Stereotypy Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
Time frame: Baseline and after 4 weeks of intervention
Change in inappropriate speech scores, as assessed by the caregiver-completed Inappropriate Speech Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Presence of Functional Gastrointestinal Symptoms as Measured by the QPGS-RIII
Time frame: Baseline and after 4 weeks of intervention
Change in the presence of any functional gastrointestinal symptoms as determined by caregiver responses to the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III (QPGS-RIII), a validated diagnostic tool for functional gastrointestinal disorders in children.
3 secondary outcomes
Change in Gut Microbiota Alpha Diversity (Shannon Index)
Time frame: Baseline and after 4 weeks of intervention
Change in Gut Microbiota Beta Diversity (UniFrac Analysis)
Time frame: Baseline and after 4 weeks of intervention
Change in Relative Abundance of Specific Bacterial Genera
Time frame: Baseline and after 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 39702309Lee JC, Chen CM, Sun CK, Tsai IT, Cheng YS, Chiu HJ, Wang MY, Tang YH, Hung KC. The therapeutic effects of probiotics on core and associated behavioral symptoms of autism spectrum disorders: a systematic review and meta-analysis. Child Adolesc Psychiatry Ment Health. 2024 Dec 19;18(1):161. doi: 10.1186/s13034-024-00848-3.
- Background: PubMed 32192218Iglesias-Vazquez L, Van Ginkel Riba G, Arija V, Canals J. Composition of Gut Microbiota in Children with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Nutrients. 2020 Mar 17;12(3):792. doi: 10.3390/nu12030792.
- Background: PubMed 31035684Srikantha P, Mohajeri MH. The Possible Role of the Microbiota-Gut-Brain-Axis in Autism Spectrum Disorder. Int J Mol Sci. 2019 Apr 29;20(9):2115. doi: 10.3390/ijms20092115.
- Background: PubMed 33356668Settanni CR, Bibbo S, Ianiro G, Rinninella E, Cintoni M, Mele MC, Cammarota G, Gasbarrini A. Gastrointestinal involvement of autism spectrum disorder: focus on gut microbiota. Expert Rev Gastroenterol Hepatol. 2021 Jun;15(6):599-622. doi: 10.1080/17474124.2021.1869938. Epub 2021 Jan 5.
- Background: PubMed 34450312Socala K, Doboszewska U, Szopa A, Serefko A, Wlodarczyk M, Zielinska A, Poleszak E, Fichna J, Wlaz P. The role of microbiota-gut-brain axis in neuropsychiatric and neurological disorders. Pharmacol Res. 2021 Oct;172:105840. doi: 10.1016/j.phrs.2021.105840. Epub 2021 Aug 24.
- Background: PubMed 31357482Martinez-Gonzalez AE, Andreo-Martinez P. The Role of Gut Microbiota in Gastrointestinal Symptoms of Children with ASD. Medicina (Kaunas). 2019 Jul 26;55(8):408. doi: 10.3390/medicina55080408.
- Background: PubMed 35406084Leader G, Abberton C, Cunningham S, Gilmartin K, Grudzien M, Higgins E, Joshi L, Whelan S, Mannion A. Gastrointestinal Symptoms in Autism Spectrum Disorder: A Systematic Review. Nutrients. 2022 Apr 1;14(7):1471. doi: 10.3390/nu14071471.
- Full-text thesis record in the Turkish National Thesis Center. The thesis no is 888255.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a 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. This study is not recruiting at the moment.
Pınar Polat, PhD principal investigator
Marmara University Pendik Training and Research Hospital
Neşe Perdahlı Fiş, Prof Dr study chair
Marmara University Pendik Training and Research Hospital
Özlem Aytekin, AProf Dr study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Low-FODMAP Diet in people with Autism Spectrum Disorder and Functional Gastrointestinal Disorders, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jul 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score (time frame: Baseline and after 4 weeks of intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07086157, which also lists 7 linked publications.
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 25 Jul 2025.