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Type 2 Diabetes MellitusNCT05418179

Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus

A study testing Probiotic in people with Type 2 Diabetes Mellitus, run by Universidade Federal de Santa Catarina at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of probiotic supplementation on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus. Study hypothesis: Supplementation of multispecies probiotic (Bifidobacterium Lactis, B. brebe, B. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteBrazil
Study dates
1 Dec 2021to 24 Dec 2023
Phase
Interventional
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age from 35 to 75 years old;
  • Individuals diagnosed with type 2 diabetes mellitus (at least 1 year ago);
  • Body mass index from 25.00 kg/m² to 39.99 kg/m²;
  • Glycated hemoglobin ≤ 9.0% ;
  • Using metformin, combined or not with other antidiabetic drugs

Who cannot join

  • Previous bowel diseases (inflammatory bowel disease and irritable bowel syndrome); or previous gastrointestinal surgery (eg, colectomy, gastrectomy)
  • Intolerances and ∕ or food allergies with a previous medical diagnosis (eg lactose intolerance or celiac disease);
  • Glomerular filtration rate <30 ml/min/1.73m²; inflammatory diseases and immunodeficiencies;
  • Diagnosis of autonomic neuropathy with gastrointestinal involvement such as: diabetic gastroparesis, diabetic enteropathy (diarrhea) or colonic hypomotility (constipation);
  • Hospital admission and/or use of anti-inflammatory drugs (non-hormonal and corticosteroids) up to 1 month before the study; and ∕or use of antibiotics up to 3 months before the study;
  • Regular use of laxatives, opioid narcotic analgesics or appetite suppressants;
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  • Current or previous use (up to 1 month) of prebiotics, probiotics, symbiotics or products enriched with these food supplements;
  • Intolerance to prebiotics, probiotics or symbiotics;
  • Pregnant or breastfeeding;
  • Follow-up of a diet, guided by a nutritionist, for weight loss or gain up to 1 month before the study or current follow-up of unusual diets (eg vegetarian, macrobiotic, paleolithic);
  • Alcohol consumption (> 1 drink/day or 14g of alcohol for women; >2 drinks/day or 28 grams of alcohol for men); use of illicit drugs and smokers;
  • Change of lipid-lowering and/or antidiabetic drugs in the last 3 months

Trial locations and contacts

1 site in 1 country.

Erasmo Trindade, PhD contact

+55 48 3721-3489

erasmotrindade@gmail.com

Brazil1 site, 1 recruiting

  • Polydoro Ernani de São Thiago University Hospital

    Florianópolis, Santa Catarina, 88036-800

    Erasmo BSM Trindade, PhD, +55 48 3721-3489, erasmotrindade@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus: Study Protocol for a Triple-blind Controlled Randomized Clinical Trial

The purpose of this study is to evaluate the effect of probiotic supplementation on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus.

Study hypothesis: Supplementation of multispecies probiotic (Bifidobacterium Lactis, B. brebe, B. longum, Lactobacillus gasseri, L. casei, L. rhamnosus) during 12 weeks improves the the fecal microbiota composition and promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with type 2 diabetes mellitus.

Read the detailed description

The purpose of this study is to evaluate the effect of multispecies probiotic supplementation (specifically designed for the present study) on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus (T2DM).

Adult individuals (35 to 75 years old) of both sexes with T2DM (diagnosed at least 1 year ago), body mass index from 25.00 kg/m² to 39.99 kg/m², glycated hemoglobin ≤ 9.0% and using metformin will be invited to participate in this randomized, placebo-controlled, triple-blind study.

The participants will be randomized into two groups: G1 - probiotic group and G2 - control group (placebo).

The study will consist of two experimental time points: M0 - baseline and start of supplementation; M1 - after 12 weeks of the first outpatient visit and start of supplementation.

In the two experimental moments, individual fecal samples will be obtained for analysis of the fecal microbiota; The metabolic parameters will be assessed by determination of circulating levels of SCFA, FFA, insulin, fasting glucose and glycated hemoglobin, HOMA-IR; Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; the inflammatory response will be assessed by determination of plasma indicadors (LPS, Adiponectina, IL-10, IL-1, IL-6, TNF- α, Leptina, Resistina) ; besides the evaluation of indicators of nutritional status (bone densitometry with body composition and anthropometric measurements).

The primary endpoint will be the fecal microbiota composition, SCFA concentrations and the inflammatory parameters.

Being tested
Probiotic, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticDietary supplement

    Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day

  • PlaceboDietary supplement

    Maltodextrin (1 capsule/day)

Study groups in NCT05418179
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMaltodextrin (1 capsule/day)
Receives: Dietary Supplement: Placebo
ProbioticActive comparatorProbiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day
Receives: Dietary Supplement: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fecal Microbiota

    analysis method: 16s rRNA sequencing and bioinformatics analysis. Reported measure: taxonomic profiles of the microbial populations (operational taxonomic units / OTUs)

    Measured: 12 weeks compared to baseline

  2. SCFA

    Acetate, propionate, isobutyrate, butyrate and isovalerate (μmol/L)

    Measured: 12 weeks compared to baseline

  3. Inflammatory parameters

    Plasma LPS, adiponectin, leptin, resistin, IL-1, IL-6, IL-8, IL-10 and TNF-alpha concentrations (pg/mL)

    Measured: 12 weeks compared to baseline

Secondary outcomes (16)

  1. Fasting insulin

    μUI/mL

    Measured: 12 weeks compared to baseline

  2. fasting blood glucose

    mg/dL

    Measured: 12 weeks compared to baseline

  3. HOMA-IR

    HOMA-IR = [fasting blood glucose (mmol) x fasting insulin (UI/ml)] ÷ 22,5

    Measured: 12 weeks compared to baseline

  4. Glycated hemoglobin

    percentage (%)

    Measured: 12 weeks compared to baseline

  5. Free Fat Acids

    µmol/L

    Measured: 12 weeks compared to baseline

  6. Triglycerides

    mg/dL.

    Measured: 12 weeks compared to baseline

  7. Total cholesterol

    mg/dL

    Measured: 12 weeks compared to baseline

  8. LDL-c

    (Friedewald equation) LDL-c = total colesterol - HDL-c - Triglicerídeos/5

    Reported measure: mg/dL

    Measured: 12 weeks compared to baseline

  9. HDL-c

    mg/dL

    Measured: 12 weeks compared to baseline

  10. Bone densitometry

    Dual X-ray Absorptiometry (DXA). Reported measure: T-score and Z-score

    Measured: 12 weeks compared to baseline

  11. Body weight (kg)

    kilograms

    Measured: 12 weeks compared to baseline

  12. Waist circumference (cm)

    centimeters (cm)

    Measured: 12 weeks compared to baseline

  13. Body mass index (BMI)

    In metric units: BMI (kg/m²) = weight (kg) ÷ height² (meters). Reported measure: kg/m².

    Measured: 12 weeks compared to baseline

  14. Total Body Fat Percentage (%BF)

    Dual X-ray Absorptiometry (DXA). Reported measure: Total Body Fat Percentage (%BF)

    Measured: 12 weeks compared to baseline

  15. Fat Mass Index (FMI)

    Dual X-ray Absorptiometry (DXA) - Fat Mass Index (FMI) - the total amount of fat (in kilograms) relative to the height (in meters²)

    Measured: 12 weeks compared to baseline

  16. Total Body lean mass Percentage (%)

    Dual X-ray Absorptiometry (DXA) - Total Body lean mass Percentage (%): The percent of the body that is not composed of fat.

    Measured: 12 weeks compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start1 Dec 2021
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion24 Dec 2023 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418179
Sponsor's protocol ID
UFSC_2021
Status last verified
Mar 2023
First submitted
5 Jun 2022
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Type 2 Diabetes Mellitus, run by Universidade Federal de Santa Catarina at 1 site in Brazil.

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 12 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 28 Mar 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 Brazil. 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.

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?

Contact Erasmo Trindade, PhD (+55 48 3721-3489, erasmotrindade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fecal Microbiota (time frame: 12 weeks compared to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418179.

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 28 Mar 2023.

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