Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

NCT02534272 | Terminated

• 1 other identifier: 6110
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• 16SrRNA copy numbers

  Within the 2 days following inclusion

Study Arms (2)

Symptomatic subjects

Subjects with intestinal symptoms

Other: Stool sampling and sequencing of gut microbiota.

Asymptomatic subjects

Subjects without intestinal symptoms

Other: Stool sampling and sequencing of gut microbiota.

Interventions

Stool sampling and sequencing of gut microbiota. OTHER

Asymptomatic subjects; Symptomatic subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic subjects will be recruited during their visit to hospital for intestinal symptoms. Asymptomatic subjects will be recruited in the general population.

You may qualify if:

• male/female aged at least of 18 years
• subject with abdominal pain, diarrhea, bloating
• no other known intestinal disease
• male/female aged at least of 18 years
• no known intestinal disease

You may not qualify if:

• chronic intestinal diseases such as IBD, IBS …
• intake of antibiotic or probiotic within the 2 last months
• subject unable to understand information for a free consent to the study
• subject in safeguarding justice or guardianship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (4)

Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Médecine interne, maladies tropicales et infectieuses Hôpital Civil

Strasbourg, 67091, France

Location

Service de Médecine Interne - Diabète et Maladies métaboliques Hôpital Civil

Strasbourg, 67091, France

Location

Service d'hépato gastro-entérologie et assistance nutritive Hôpital Hautepierre

Strasbourg, 67098, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CANDOLFI Ermanno, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 27, 2015
• Study Start: February 16, 2016
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (4)