Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

August 5, 2021 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67091
        • Médecine interne, maladies tropicales et infectieuses Hôpital Civil
      • Strasbourg, France, 67091
        • Service de Médecine Interne - Diabète et Maladies métaboliques Hôpital Civil
      • Strasbourg, France, 67098
        • Service d'hépato gastro-entérologie et assistance nutritive Hôpital Hautepierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria for symptomatic group:

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

Inclusion Criteria for asymptomatic group:

  • male/female aged at least of 18 years
  • no known intestinal disease

Exclusion Criteria of symptomatic and asymptomatic groups:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
16SrRNA copy numbers
Time Frame: Within the 2 days following inclusion
Within the 2 days following inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: CANDOLFI Ermanno, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2016

Primary Completion (Actual)

March 29, 2019

Study Completion (Actual)

March 29, 2019

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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