Does the Negativation of the Glucose Hydrogen Breath Test... | NCT01275560

Studies
Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?

NCT01275560

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

May 15, 2026Actual

Enrollment

16Actual

Phase

Phase 3

Conditions

Anal Incontinence

Interventions

Metronidazole
CArbosylane

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

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jan 11, 2011

First Submission Date that Met QC Criteria

Jan 11, 2011

First Posted Date

Jan 12, 2011Estimated

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

May 12, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metronidazole	Experimental	3 intakes per day during 10 days	Drug: Metronidazole
Carbosylane	Active Comparator	3 intakes per daysduring 10 days	Drug: CArbosylane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metronidazole	Drug	Metronidazole,per os,500mg, 3 per day during 10 days	Metronidazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of gaz incontinence episodes		3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gaz incontinence for more than 3 months
Afflilied to national health security
Having read and sign the information letter and consent form

Exclusion Criteria:

Pregnancy
use of antibiotics, probiotics, IPP for less tha n 3 months
past of small intestinal bacterial overgrowth
ischemic, inflammatory colitis,colo-rectal cancer
diabetes
allergy to metronidazole
psychiatric disease
patients who do not speak or read french

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont		Rouen		76031	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28763464	Result	Melchior C, Gourcerol G, Bridoux V, Ducrotte P, Quinton JF, Leroi AM. Efficacy of antibiotherapy for treating flatus incontinence associated with small intestinal bacterial overgrowth: A pilot randomized trial. PLoS One. 2017 Aug 1;12(8):e0180835. doi: 10.1371/journal.pone.0180835. eCollection 2017.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001526	Behavioral Symptoms

ID	Term
D009593	Nitroimidazoles
D009574	Nitro Compounds
D009930	Organic Chemicals
D007093	Imidazoles