Intestinal ObstructionMETADOLOMICNCT06610929
Intestinal Microbiota and Visceral Pain in Chronic Intestinal Pseudo-Obstruction Syndrome (CIPO)
An observational study of Intestinal Obstruction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic Intestinal Pseudo-Obstruction Syndrome (CIPO) is a rare gastrointestinal motility disorder. CIPO evolves through iterative flare-ups that can be triggered by viral or bacterial infections, psychological stress, or malnutrition. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Intestinal Obstruction
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 1 Nov 2025
- Phase
- Observational
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient diagnosed with CIPO for at least 12 months (= patients meeting at least 2 of the following 4 criteria: 1. Recurrent episodes of intestinal dilatation, 2. Inability to maintain nutrition, 3. Intestinal neuromuscular alteration and 4. Genetic variants.)
Who may be able to join
- Patient aged 1 to 21 years
- Patient diagnosed with CIPO for at least 12 months (= patients meeting at least 2 of the following 4 criteria: 1. Recurrent episodes of intestinal dilatation, 2. Inability to maintain nutrition, 3. Intestinal neuromuscular alteration and 4. Genetic variants.)
- Patient with an ileal or colonic digestive diversion
- Signature of informed consent by both holders of parental authority and agreement in principle given orally by the subject;
- Patients affiliated to a social security scheme
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Robert Debre Hospital
Paris, 75019
Alexis MOSCA, MD, 0187891646, alexis.mosca@aphp.fr
Emmanuelle ECOCHARD-DUGELAY, MD, 0187891646, emmanuelle.dugelay@aphp.fr
About this study
Official title: Metabolites From the Intestinal Microbiota and Visceral Pain Associated With Chronic Intestinal Pseudo-obstruction (CIPO) in Children
Chronic Intestinal Pseudo-Obstruction Syndrome (CIPO) is a rare gastrointestinal motility disorder. CIPO evolves through iterative flare-ups that can be triggered by viral or bacterial infections, psychological stress, or malnutrition. All of these factors are associated with dysbiosis of the intestinal microbiota (IM). Many studies have associated visceral pain with dysbiosis of the IM, particularly in the context of irritable bowel syndrome (IBS), a painful pathology associated with transit disorders. The team in Dr. Cénac's laboratory has demonstrated the analgesic effect of a bacterial lipid produced by an intestinal bacterium in the context of IBS. The study hypothesize that CIPO patients have a taxonomic and functional dysbiosis of the IM responsible for hyperactivation of sensory neurons inducing visceral pain.
Read the detailed description
The aim of the study is to identify metabolites differentially produced by the gut microbiota of CIPO patients with visceral pain to determine their effect on the host with a focus on intestinal homeostasis.
For that, 3 samples of digestive effluent will be collected in paediatric CIPO patients.
Then, the study will:
- Characterize the intestinal microbiota of digestive effluents from painful and non-painful pediatric CIPO patients.
- Quantify bacterial lipids in digestive effluents from painful and non-painful paediatric CIPO patients. In ileal effluents, we will perform absolute quantification of the bacterial lipidome. We will quantify short-chain fatty acids by gas chromatography coupled with mass spectrometry and, long-chain beta-hydroxylated fatty acids, GABA-lipopeptides, lipoamines and primary and secondary bile acids by liquid chromatography coupled with tandem mass spectrometry.
- Test the function of these bacterial lipids on sensory neuronal activity in a primary culture of mouse dorsal root ganglia. The effects of bacterial lipids on sensory neurons will be evaluated in a primary culture of mouse dorsal root ganglia. We will quantify calcium mobilization in sensory neurons treated with the lipid compounds identified above. In a second step, in order to determine their inhibitory potential, the same experiments will be performed on neurons activated by a calcium channel receptor agonist, TRPV1 (capsaicin) or by a mix of agonists (histamine, serotonin and bradykinin) of G protein-coupled receptors involved in visceral hypersensitivity
- Conditions
- Intestinal Obstruction
- Keywords
- Microbiota
- Medical subject headings
- Intestinal Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature and quantity of bacteria identified by sequencing in the digestive effluent of painful and non-painful CIPO pediatric patients
microbiota analysis by DNA sequencing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis MOSCA, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610929
- Sponsor's protocol ID
- APHP240437
- Other IDs
- IDRCB: 2024-A00717-40
- Acronym
- METADOLOMIC
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolites From the Intestinal Microbiota and Visceral Pain Associated With Chronic Intestinal Pseudo-obstruction (CIPO) in Children
- ClinicalTrials.gov ID
- NCT06610929
- Acronym / sponsor ID
- METADOLOMIC / APHP240437
- Conditions
- Intestinal Obstruction
- Keywords
- Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 24 Sep 2024 (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.
Chronic Intestinal Pseudo-Obstruction Syndrome (CIPO) is a rare gastrointestinal motility disorder. CIPO evolves through iterative flare-ups that can be triggered by viral or bacterial infections, psychological stress, or malnutrition. All of these factors are associated with dysbiosis of the intestinal microbiota (IM). Many studies have associated visceral pain with dysbiosis of the IM, particularly in the context of irritable bowel syndrome (IBS), a painful pathology associated with transit disorders. The team in Dr. Cénac's laboratory has demonstrated the analgesic effect of a bacterial lipid produced by an intestinal bacterium in the context of IBS. The study hypothesize that CIPO patients have a taxonomic and functional dysbiosis of the IM responsible for hyperactivation of sensory neurons inducing visceral pain.
Detailed description
The aim of the study is to identify metabolites differentially produced by the gut microbiota of CIPO patients with visceral pain to determine their effect on the host with a focus on intestinal homeostasis.
For that, 3 samples of digestive effluent will be collected in paediatric CIPO patients.
Then, the study will:
- Characterize the intestinal microbiota of digestive effluents from painful and non-painful pediatric CIPO patients.
- Quantify bacterial lipids in digestive effluents from painful and non-painful paediatric CIPO patients. In ileal effluents, we will perform absolute quantification of the bacterial lipidome. We will quantify short-chain fatty acids by gas chromatography coupled with mass spectrometry and, long-chain beta-hydroxylated fatty acids, GABA-lipopeptides, lipoamines and primary and secondary bile acids by liquid chromatography coupled with tandem mass spectrometry.
- Test the function of these bacterial lipids on sensory neuronal activity in a primary culture of mouse dorsal root ganglia. The effects of bacterial lipids on sensory neurons will be evaluated in a primary culture of mouse dorsal root ganglia. We will quantify calcium mobilization in sensory neurons treated with the lipid compounds identified above. In a second step, in order to determine their inhibitory potential, the same experiments will be performed on neurons activated by a calcium channel receptor agonist, TRPV1 (capsaicin) or by a mix of agonists (histamine, serotonin and bradykinin) of G protein-coupled receptors involved in visceral hypersensitivity
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient diagnosed with CIPO for at least 12 months (= patients meeting at least 2 of the following 4 criteria: 1. Recurrent episodes of intestinal dilatation, 2. Inability to maintain nutrition, 3. Intestinal neuromuscular alteration and 4. Genetic variants.)
Key inclusion criteria (5 listed)
- Patient aged 1 to 21 years
- Patient diagnosed with CIPO for at least 12 months (= patients meeting at least 2 of the following 4 criteria: 1. Recurrent episodes of intestinal dilatation, 2. Inability to maintain nutrition, 3. Intestinal neuromuscular alteration and 4. Genetic variants.)
- Patient with an ileal or colonic digestive diversion
- Signature of informed consent by both holders of parental authority and agreement in principle given orally by the subject;
- Patients affiliated to a social security scheme
Key exclusion criteria (1 listed)
- -
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
Nature and quantity of bacteria identified by sequencing in the digestive effluent of painful and non-painful CIPO pediatric patients
Time frame: 12 months
microbiota analysis by DNA sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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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.
Alexis MOSCA, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Intestinal Obstruction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis MOSCA, MD (0187891646, alexis.mosca@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature and quantity of bacteria identified by sequencing in the digestive effluent of painful and non-painful CIPO pediatric patients (time frame: 12 months). 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 26 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.