IBS - Irritable Bowel SyndromeMicroRestoreNCT07517029
Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome
An observational study of IBS - Irritable Bowel Syndrome and Post Infection Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Observational, multicenter, prospective study aimed at characterizing the gut microbiome in patients with post-infectious irritable bowel syndrome (PI-IBS) using whole genome sequencing (WGS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Post Infection Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 315 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2026to Dec 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include adults with post-infectious irritable bowel syndrome (PI-IBS) (n= 105) and two control groups: individuals with a history of acute gastroenteritis without persistent gastrointestinal symptoms (n = 105) , and healthy subjects (n = 105) . All participants will be recruited from clinical centers and donor programs and will undergo clinical assessment and stool sample collection for microbiome analysis.
Who may be able to join
- Age ≥ 18 years old
- PI-IBS diagnosed according to Rome IV criteria (33).
- Diagnosis no earlier than 3 months before enrollment.
- Written informed consent and compliance with study procedures.
- Age ≥ 18 years old
- History of acute infectious gastroenteritis >6 months before enrollment.
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- Complete recovery without persistent GI symptoms.
- Age ≥ 18 years old
- Healthy donors from FMT program or blood donor program.
- No history of GI or systemic disorders.
Who cannot join
- Chronic organic gastrointestinal (GI) disorders (e.g. Inflammatory Bowel Disease -IBD), metabolic syndrome, obesity, diabetes, GI cancers, systemic autoimmune disorders.
- History of major abdominal surgery.
- Control cohort #1 - Post-infectious non-IBS (n = 105)
- Current or past diagnosis of IBS.
- Any chronic GI or systemic disorders.
- Control cohort #2 - Healthy subjects (n = 105)
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- Any GI or systemic chronic condition.
- Recent antibiotics/probiotics (<4 weeks).
- Chronic medication affecting microbiome composition (e.g. PPI)
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
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
Rome, 00168
Gianluca Ianiro, MD, 0630156265, gianluca.ianiro@hotmail.it
About this study
Official title: Informed Ecological Rewiring of Gut Microbiome for Dysbiosis-associated Disorders
Observational, multicenter, prospective study aimed at characterizing the gut microbiome in patients with post-infectious irritable bowel syndrome (PI-IBS) using whole genome sequencing (WGS). The study will compare microbiome composition and function between PI-IBS patients and two control groups (post-infectious subjects without irritable bowel syndrome -IBS- and healthy controls), with the goal of identifying reproducible microbial signatures and target taxa associated with disease and symptom severity.
Read the detailed description
The human gut microbiome plays a key role in host physiology, including immune regulation, metabolism, and protection against pathogens. Alterations in microbiome composition (dysbiosis) have been associated with multiple diseases, including post-infectious irritable bowel syndrome (PI-IBS), a condition that develops after acute gastroenteritis and represents a well-defined model of microbiome disruption.
MicroRestore-1 is a national, multicenter, prospective observational study designed to characterize the gut microbiome of patients with PI-IBS and identify microbial signatures associated with the disease. The study represents Aim 1 of a broader research program investigating precision microbiome modulation strategies.
A total of 315 participants will be enrolled, including 105 PI-IBS patients, 105 post-infectious subjects without IBS, and 105 healthy controls. PI-IBS will be diagnosed according to Rome IV criteria. Eligible participants will undergo baseline clinical assessment, including symptom evaluation using the IBS Severity Scoring System (IBS-SSS), medical history, dietary habits, and lifestyle factors.
Stool samples will be collected at baseline and, for PI-IBS patients, at monthly follow-up visits for three months. Control subjects will provide a single sample at enrollment. All samples will be processed and stored under standardized conditions and analyzed centrally.
Microbiome analysis will be performed using whole genome shotgun sequencing, enabling high-resolution taxonomic and functional profiling. Bioinformatic and statistical analyses, including machine learning approaches, will be used to identify microbial signatures discriminating PI-IBS patients from controls and to explore associations between microbiome features and disease activity.
The primary objective is to identify reproducible microbial signatures and target taxa associated with PI-IBS. Secondary objectives include comparing microbiome composition and function across study groups and evaluating correlations between microbiome features and symptom severity.
This study is expected to provide foundational data for the development of precision microbiome-based therapeutic strategies in PI-IBS.
- Medical subject headings
- Irritable Bowel Syndrome, Post-Infectious Disorders
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 |
|---|---|---|
| Post-infectious-IBS patients | Patients diagnosed with post-infectious irritable bowel syndrome (PI-IBS) according to Rome IV criteria. Participants must be ≥18 years old and diagnosed within 3 months prior to enrollment. Clinical data, including IBS severity scoring system (IBS-SSS), medical history, diet, and lifestyle factors will be collected. Stool samples will be collected at baseline and at monthly follow-up visits for 3 months. | |
| Post-infectious non-IBS controls | Adults ≥18 years old with a history of acute infectious gastroenteritis occurring more than 6 months prior to enrollment, with complete recovery and no persistent gastrointestinal symptoms or diagnosis of IBS. One stool sample and associated clinical and lifestyle data will be collected at enrollment. | |
| Healthy controls | Healthy adult subjects ≥18 years old with no history of gastrointestinal or systemic disorders, recruited from fecal microbiota transplantation (FMT) or blood donor programs. Participants must not have taken antibiotics or probiotics within 4 weeks prior to enrollment. One stool sample and associated demographic and lifestyle data will be collected at enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of microbial signatures discriminating PI-IBS from controls
Identification of reproducible gut microbiome signatures, including taxonomic and functional profiles, that discriminate patients with post-infectious irritable bowel syndrome (PI-IBS) from control groups using whole genome shotgun sequencing and machine learning approaches.
Measured: Baseline up to 30 months (end of study)
Secondary outcomes (1)
Association between microbiome features and disease severity
Evaluation of associations between gut microbiome composition and function and disease activity, as measured by the IBS Severity Scoring System (IBS-SSS).
Measured: Baseline up to 30 months (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start8 Apr 2026
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IANIRO GIANLUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Gianluca Ianiro, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517029
- Sponsor's protocol ID
- 26967
- Acronym
- MicroRestore
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Ecological Rewiring of Gut Microbiome for Dysbiosis-associated Disorders
- ClinicalTrials.gov ID
- NCT07517029
- Acronym / sponsor ID
- MicroRestore / 26967
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Apr 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.
Observational, multicenter, prospective study aimed at characterizing the gut microbiome in patients with post-infectious irritable bowel syndrome (PI-IBS) using whole genome sequencing (WGS). The study will compare microbiome composition and function between PI-IBS patients and two control groups (post-infectious subjects without irritable bowel syndrome -IBS- and healthy controls), with the goal of identifying reproducible microbial signatures and target taxa associated with disease and symptom severity.
Detailed description
The human gut microbiome plays a key role in host physiology, including immune regulation, metabolism, and protection against pathogens. Alterations in microbiome composition (dysbiosis) have been associated with multiple diseases, including post-infectious irritable bowel syndrome (PI-IBS), a condition that develops after acute gastroenteritis and represents a well-defined model of microbiome disruption.
MicroRestore-1 is a national, multicenter, prospective observational study designed to characterize the gut microbiome of patients with PI-IBS and identify microbial signatures associated with the disease. The study represents Aim 1 of a broader research program investigating precision microbiome modulation strategies.
A total of 315 participants will be enrolled, including 105 PI-IBS patients, 105 post-infectious subjects without IBS, and 105 healthy controls. PI-IBS will be diagnosed according to Rome IV criteria. Eligible participants will undergo baseline clinical assessment, including symptom evaluation using the IBS Severity Scoring System (IBS-SSS), medical history, dietary habits, and lifestyle factors.
Stool samples will be collected at baseline and, for PI-IBS patients, at monthly follow-up visits for three months. Control subjects will provide a single sample at enrollment. All samples will be processed and stored under standardized conditions and analyzed centrally.
Microbiome analysis will be performed using whole genome shotgun sequencing, enabling high-resolution taxonomic and functional profiling. Bioinformatic and statistical analyses, including machine learning approaches, will be used to identify microbial signatures discriminating PI-IBS patients from controls and to explore associations between microbiome features and disease activity.
The primary objective is to identify reproducible microbial signatures and target taxa associated with PI-IBS. Secondary objectives include comparing microbiome composition and function across study groups and evaluating correlations between microbiome features and symptom severity.
This study is expected to provide foundational data for the development of precision microbiome-based therapeutic strategies in PI-IBS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-infectious-IBS patients | – | –Patients diagnosed with post-infectious irritable bowel syndrome (PI-IBS) according to Rome IV criteria. Participants must be ≥18 years old and diagnosed within 3 months prior to enrollment. Clinical data, including IBS severity scoring system (IBS-SSS), medical history, diet, and lifestyle factors will be collected. Stool samples will be collected at baseline and at monthly follow-up visits for 3 months. |
| Post-infectious non-IBS controls | – | –Adults ≥18 years old with a history of acute infectious gastroenteritis occurring more than 6 months prior to enrollment, with complete recovery and no persistent gastrointestinal symptoms or diagnosis of IBS. One stool sample and associated clinical and lifestyle data will be collected at enrollment. |
| Healthy controls | – | –Healthy adult subjects ≥18 years old with no history of gastrointestinal or systemic disorders, recruited from fecal microbiota transplantation (FMT) or blood donor programs. Participants must not have taken antibiotics or probiotics within 4 weeks prior to enrollment. One stool sample and associated demographic and lifestyle data will be collected at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include adults with post-infectious irritable bowel syndrome (PI-IBS) (n= 105) and two control groups: individuals with a history of acute gastroenteritis without persistent gastrointestinal symptoms (n = 105) , and healthy subjects (n = 105) . All participants will be recruited from clinical centers and donor programs and will undergo clinical assessment and stool sample collection for microbiome analysis.
Key inclusion criteria (10 listed)
Key exclusion criteria (9 listed)
- Control cohort #1 - Post-infectious non-IBS (n = 105)
- Control cohort #2 - Healthy subjects (n = 105)
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
Identification of microbial signatures discriminating PI-IBS from controls
Time frame: Baseline up to 30 months (end of study)
Identification of reproducible gut microbiome signatures, including taxonomic and functional profiles, that discriminate patients with post-infectious irritable bowel syndrome (PI-IBS) from control groups using whole genome shotgun sequencing and machine learning approaches.
1 secondary outcome
Association between microbiome features and disease severity
Time frame: Baseline up to 30 months (end of study)
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Gianluca Ianiro principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 IBS - Irritable Bowel Syndrome and Post Infection Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 10 inclusion and 9 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 13 Apr 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 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 Gianluca Ianiro (+390630155701, gianluca.ianiro@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of microbial signatures discriminating PI-IBS from controls (time frame: Baseline up to 30 months (end of study)). 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 13 Apr 2026.