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NCT02534272 Clinical Trial

Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

Diarrhea Clinical Trial

Official title:
Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02534272
Other study ID # 6110
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 16, 2016
Est. completion date March 29, 2019

Study information
Verified date August 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 25
Est. completion date March 29, 2019
Est. primary completion date March 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Stool sampling and sequencing of gut microbiota.

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

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 16SrRNA copy numbers Within the 2 days following inclusion
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