ObesePhase 1BIOPREDNCT05878444
Evaluation of the Colonization Capacity of a Probiotic Bacterium.
A Phase 1 study testing Probiotic in people with Obese and Weight, Body, run by Valencian Innovation Agency at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Weight, Body
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 31 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Agrochemistry and Food Technology
Paterna, Valencia, 46980
Yolanda Sanz Herranz, Pharmacist, +34 963 900 022 ext. 435240, yolsanz@iata.csic.es
María Tamayo García, Nutritionist, +34 963 900 022 ext. 435234, mtamayo@iata.csic.es
About this study
Official title: Evaluate the Colonization Capacity of a New Generation Probiotic Within the Project: Valorization of an Intestinal Bacterium as a Functional Ingredient to Prevent the Development of Metabolic Syndrome and Diabetes -BIOPRED
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.
Read the 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.
- Conditions
- Obese, Weight, Body
- Being tested
- Probiotic
- Keywords
- probiotic, Obese, Colonization, Microbiota
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Resistant gastrointestinal capsules will be provided daily to the participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of our bacteria in feces
By specific PCR or by 16s sequencing
Measured: Before the end of 2023
Secondary outcomes (1)
Adverse effect
Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale.
Measured: Before the end of 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will try the probiotic in normal weight and overweight/obese people
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valencian Innovation Agency
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yolanda Sanz Herranz, Institute of Agrochemistry and Food Technology, National Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878444
- Sponsor's protocol ID
- INNVA1/2021/32
- Acronym
- BIOPRED
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidentiality and protection of personal data law
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Colonization Capacity of a New Generation Probiotic Within the Project: Valorization of an Intestinal Bacterium as a Functional Ingredient to Prevent the Development of Metabolic Syndrome and Diabetes -BIOPRED
- ClinicalTrials.gov ID
- NCT05878444
- Acronym / sponsor ID
- BIOPRED / INNVA1/2021/32
- Conditions
- Obese, Weight, Body
- Keywords
- probiotic, Obese, Colonization, Microbiota
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Valencian Innovation AgencyOther government
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will try the probiotic in normal weight and overweight/obese people
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Experimental | Dietary Supplement: ProbioticPeople 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. |
| Overweight/Obese | Experimental | Dietary Supplement: ProbioticPeople 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticResistant gastrointestinal capsules will be provided daily to the participants. | Dietary supplement | Normal weight, Overweight/Obese |
Primary outcome
Presence of our bacteria in feces
Time frame: Before the end of 2023
By specific PCR or by 16s sequencing
1 secondary outcome
Adverse effect
Time frame: Before the end of 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No. confidentiality and protection of personal data law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institute of Agrochemistry and Food Technology
Paterna, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotic in people with Obese and Weight, Body, run by Valencian Innovation Agency at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of our bacteria in feces (time frame: Before the end of 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.