Study of the Interactions Between Dientamoba Fragilis and... | NCT02534272

Studies
Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

NCT02534272

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Mar 12, 2025Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Diarrhea

Interventions

Stool sampling and sequencing of gut microbiota.

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2016Actual

Primary Completion Date

Mar 29, 2019Actual

Completion Date

Mar 29, 2019Actual

First Submitted Date

Aug 24, 2015

First Submission Date that Met QC Criteria

Aug 26, 2015

First Posted Date

Aug 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Stool sampling and sequencing of gut microbiota.	Other		Asymptomatic subjects Symptomatic subjects

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CANDOLFI Ermanno, MD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided