Diabetes type2Early Phase 1EPI-MICROBIONCT05076656
Epigenetic and Microbiota Modifications
A Early Phase 1 study testing Lactobacillus fermentum D3 and Fecal microbiota transplant (FMT) in people with Diabetes type2 and Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes type2, Obesity
- What is being tested?
- Lactobacillus fermentum D3 and Fecal microbiota transplant (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2019to 30 Jun 2022
- Phase
- Early 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type2 diabetes in treatment with metformin
- 30 kg/m2≤IMC≤40 kg/m2
- 30-70 years old
- HOMA-IR >6
- Informed consent
Who cannot join
- psychopathologic alterations that do not permit the adherence to the trial.
- Diabetes medication different from metformin.
- History of cholecystectomy.
- Use of Probiotics, and/or antibiotics in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.
- Conditions
- Diabetes type2, Obesity
- Being tested
- Lactobacillus fermentum D3, Fecal microbiota transplant (FMT), Placebo
- Keywords
- Diabetes type2, FMT, Probiotics, Microbiota
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus fermentum D3Dietary supplement
Also called PCT/EP 2012058214
Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
Fecal microbiota transplant (FMT)Biological
Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
PlaceboDrug
Placebo in a white, gelatin capsule (orally), with powder milk
| Study group | Role | What they receive |
|---|---|---|
| Probiotics arm | Experimental | Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214) Receives: Dietary Supplement: Lactobacillus fermentum D3 |
| FMT arm | Experimental | Individuals who receive a FMT in the form of pills with fecal material from a healthy donor. Receives: Biological: Fecal microbiota transplant (FMT) |
| Control arm | Placebo comparator | Individuals who receive a probiotics pill daily of placebo (milk powder) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HOMA-IR
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Changes in gut microbiota
Change from baseline in 16S rRNA amplicons after 3 months
Measured: Baseline, 12 weeks
Changes in glucose metabolism
Change from baseline in oral glucose tolerance test (OGTT)
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start10 Jun 2019
- Primary completion17 Oct 2020
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type2Studies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco J Tinahones, MD, PhD, Principal investigator, Instituto de Investigacion Biomedica de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076656
- Sponsor's protocol ID
- EPIGEN-MICROBIOTA
- Acronym
- EPI-MICROBIO
- Status last verified
- Jul 2021
- First submitted
- 15 Sep 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
- ClinicalTrials.gov ID
- NCT05076656
- Acronym / sponsor ID
- EPI-MICROBIO / EPIGEN-MICROBIOTA
- Conditions
- Diabetes type2, Obesity
- Keywords
- Diabetes type2, FMT, Probiotics, Microbiota
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Oct 2021 (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.
In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics arm | Experimental | Dietary Supplement: Lactobacillus fermentum D3Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214) |
| FMT arm | Experimental | Biological: Fecal microbiota transplant (FMT)Individuals who receive a FMT in the form of pills with fecal material from a healthy donor. |
| Control arm | Placebo comparator | Drug: PlaceboIndividuals who receive a probiotics pill daily of placebo (milk powder) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type2 diabetes in treatment with metformin
- 30 kg/m2≤IMC≤40 kg/m2
- 30-70 years old
- HOMA-IR >6
- Informed consent
Key exclusion criteria (4 listed)
- psychopathologic alterations that do not permit the adherence to the trial.
- Diabetes medication different from metformin.
- History of cholecystectomy.
- Use of Probiotics, and/or antibiotics in the last 3 months
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 |
|---|---|---|
| Lactobacillus fermentum D3Also: PCT/EP 2012058214Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives. | Dietary supplement | Probiotics arm |
| Fecal microbiota transplant (FMT)Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material. | Biological | FMT arm |
| PlaceboPlacebo in a white, gelatin capsule (orally), with powder milk | Drug | Control arm |
Primary outcome
Changes in HOMA-IR
Time frame: Baseline, 12 weeks
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
2 secondary outcomes
Changes in gut microbiota
Time frame: Baseline, 12 weeks
Changes in glucose metabolism
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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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.
Francisco J Tinahones, MD, PhD principal investigator
Instituto de Investigacion Biomedica de Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lactobacillus fermentum D3 and Fecal microbiota transplant (FMT) in people with Diabetes type2 and Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 4 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: finished, as of the sponsor's last update on 22 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HOMA-IR (time frame: Baseline, 12 weeks). 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 22 Jul 2022.