Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions... | NCT06114303

Studies
Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota

NCT06114303

Sponsor

Larena SAS

Status

Terminated

Last Update Posted

Dec 2, 2025Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Dysbiosis

Interventions

Stool sampling

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was terminated early on 16/06/2025 because the initial results obtained from the 14 pairs of patients included were sufficient to satisfactorily address the research question posed in the context of the thesis.

Expanded Access Info

Start Date

Mar 14, 2024Actual

Primary Completion Date

Jun 16, 2025Actual

Completion Date

Jun 16, 2025Actual

First Submitted Date

Feb 27, 2023

First Submission Date that Met QC Criteria

Oct 27, 2023

First Posted Date

Nov 2, 2023Actual

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

Nov 24, 2025

Last Update Posted Date

Dec 2, 2025Actual

Name	Class
Université Paris-Saclay	OTHER

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

14Actual

Label	Type	Description	Intervention Names
"Mother"		Healthy women	Other: Stool sampling
"Daughter"		Healthy "daughter" from "Mother" subjects	Other: Stool sampling

Name	Type	Description	Arm Group Labels	Other Names
Stool sampling	Other	1 stool sample is taken during the study with a stool sample kit	"Daughter" "Mother"

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transcriptional activity of microbiomes	Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA	10 months
Transcriptomic profiles of the communities	Transcriptomic profiles of the communities assessed by meta-transcriptomics	10 months
Metabolites produced and microbial metabolic pathways	Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult "Mother" population:

Women aged 25-40 years;
In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or long-term treatment,
With a regular bowel movement frequency (at least once every 2 days)
BMI between 18.5 and 25
Able and willing to participate in the research by complying with the protocol procedures
Not objecting to the collection and processing of their personal data

Child "Daughter" population

Girl between 1 and 2 years old
In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or on a long-term basis,
With a regular stool frequency (at least once every 2 days)
Whose mother does not object to the collection and processing of personal data

Exclusion Criteria:

Adult "Mother" population :

Pregnant or breastfeeding women,
Under antibiotic treatment, or having stopped it for less than a month.
Under dietary supplementation (prebiotics or probiotics) or having stopped it less than one month before
On antidepressants and/or anxiolytics in the month before inclusion
Taking a non-steroidal anti-inflammatory drug (NSAID) the month before inclusion.
On PPI, or having stopped it less than one month before.
Persons under court protection,
Person participating in another research study with an ongoing exclusion period,

Child "Daughter" population:

Outside the WHO normal growth charts (weight for height) for girls aged 0-2 years (below the 3rd percentile or above the 97th percentile)
Undergoing antibiotic treatment, or having stopped it less than a month ago.
Having taken a non-steroidal anti-inflammatory drug (NSAID) in the month prior to inclusion.
On dietary supplements (prebiotics or probiotics) or having stopped them within the last month
Subjects participating in another research study with an ongoing exclusion period

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

The mother/daughter " duos " participating in the study will be drawn from a panel of volunteers.

Sampling Method

Non-Probability Sample

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms