Intestinal Microbiota and Visceral Pain in Chronic Intestinal Pseudo-Obstruction Syndrome (CIPO)

NCT06610929 | Not Yet Recruiting

• 2 other identifiers: APHP240437IDRCB: 2024-A00717-40
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intestinal Obstruction

Keywords

Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.)

You may qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Digestive effluent

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Alexis MOSCA, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis MOSCA, MD

CONTACT

0187891646; alexis.mosca@aphp.fr

Emmanuelle ECOCHARD-DUGELAY, MD

CONTACT

0187891646; emmanuelle.dugelay@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

FR (1)