Evaluation of the Colonization Capacity of a Probiotic Ba... | NCT05878444

Studies
Evaluation of the Colonization Capacity of a Probiotic Bacterium.

NCT05878444

Sponsor

Valencian Innovation Agency

Status

Unknown status

Last Update Posted

May 26, 2023Actual

Enrollment

15Estimated

Phase

Phase 1

Conditions

Obese
Weight, Body

Interventions

Probiotic

Countries

Spain

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

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Estimated

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Jan 31, 2024Estimated

First Submitted Date

May 17, 2023

First Submission Date that Met QC Criteria

May 25, 2023

First Posted Date

May 26, 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

May 25, 2023

Last Update Posted Date

May 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 goal of this interventional study is to test the colonization of a new generation probiotic in normal weight and overweight/obese people.

The main question aims to answer is if our bacteria is able to colonize the human intestine.

Participants will recieve a probiotic pill every day during 15 consecutive days and fill in questionaries.

Detailed Description

Normal weight and overweight volunteers will be recruited to evaluate the colonization capacity of the bacteria. In this case, stool samples will be taken before starting the intervention (T0), after the treatment (T1) and a week after fiinishing the administration of the probiotic (T2). All the subjects will receive the probiotic supplement in capsules taken daily, 7-8 normal weight subjects will take a concentration of 10^9-10 CFU and 7-8 overweight subjects will take a concentration of 10^9-10 CFU.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal weight	Experimental	People with BMI between 20-25 will be enrolled in this group. They will take the probiotic capsule daily during 15 days. Dosis will be 10^9-10.	Dietary Supplement: Probiotic
Overweight/Obese	Experimental	People with BMI >25 will be enrolled in this group. They will take the probiotic capsule daily during 15 days. Dosis will be 10^9-10.	Dietary Supplement: Probiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	Resistant gastrointestinal capsules will be provided daily to the participants.	Normal weight Overweight/Obese

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of our bacteria in feces	By specific PCR or by 16s sequencing	Before the end of 2023

Secondary Outcomes

Measure	Description	Time Frame
Adverse effect	Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale.	Before the end of 2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 65 years.
Body mass index between 20-25 kg/m2 for normopese subjects and BMI 25-30 kg/m2 for overweight participants.
Body weight and eating habits stable in the last three months before the first visit.
Willingness to participate in the intervention study, giving their data and samples.
Signature and acceptance of the informed consent.

Exclusion Criteria:

Preexistence of other physical conditions (food allergy/sensitivity, gastrointestinal conditions [such as inflammatory bowel disease, celiac disease, pancreatitis, chronic constipation, etc.], immunodeficiency)
Eating disorders
Use of antibiotics one month prior to the first visit
Chronic use of medications (antacids, antidiabetics, anti-hypertensives, etc.)
History or current abuse of drugs or alcohol
Following a vegetarian, vegan, or other restrictive diet
Any other reason deemed appropriate for exclusion at the clinician's discretion
Non-compliance with adherence to treatment regimen
Direct association with research and/or investigators

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Agrochemistry and Food Technology		Paterna	Valencia	46980	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

confidentiality and protection of personal data law

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D001835	Body Weight

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided