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

Dysbiosis Clinical Trial

— EPROMED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06114303
• Other study ID #: PIL-RIPH3-EPROMED-023
• Status: Not yet recruiting
• Start date: January 20, 2025
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2023
• Source: Larena SAS
• Contact: Quentin DAUCHET
• Phone: +33144388838
• Email: q.dauchet[@]pileje.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective is to test ex-vivo the effects of two probiotic solutions (Lactibiane ATB and Lactibiane Enfant) and five classes of drugs (antibiotic, proton pump inhibitor, non-steroidal anti-inflammatory, anxiolytic and anti-depressant) on microbial microcosms derived from human stool samples (from adults and children) re-cultured under anaerobic conditions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 1 Year to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis

Intervention

Other:
• Stool sampling
1 stool sample is taken during the study with a stool sample kit

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Larena SAS	Université Paris-Saclay

Outcome

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