NCT01765517

Brief Summary

Probiotics, which are believed to be health promoting live microorganisms, have been reported to influence circulating endotoxin levels. Ingestion of the live cultures may alter gut mircobiota in a beneficial manner to reduce inflammation; although their mechanism and influence to reduce inflammation in T2DM is not established for this disease state. Therefore, the aim of this study is to (1) characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low-grade inflammation in patients with T2DM; (2) Compare circulating endotoxin levels and inflammatory cytokine levels between patients treated with probiotics or placebo to examine the beneficial effects of probiotics on reducing the inflammatory status, through assessment of systemic markers (adipokines, endotoxin, cytokines); (3) to examine the effects of probiotics on gut microflora in order to understand the mechanism for such change in inflammatory status. To achieve this, 120 consenting adult Saudis, naïve or newly diagnosed T2DM patients without co-morbidities, will be enrolled in this clinical trial and randomized to receive twice-daily placebo or probiotics for 26 weeks in a double-blind manner. Glycemic inflammatory markers will be measured and fecal samples analysed, interventions will be done at baseline, 4, 8, 12 and 26 weeks. It is envisaged that probiotics will induce beneficial changes in gut mircobiota, reduce the systemic inflammatory state through altering systemic endotoxin levels and, as such, reduce the systemic inflammatory response observed in T2DM subjects. This will have a fundamental impact on how we should treat the inflammatory component of T2DM, particularly once the results are verified in a larger cohort of patients, as this could have very dramatic effects on how we treat patients with T2DM. Reducing the pathogenesis of T2DM by dampening the inflammatory response, which may also impact on insulin resistance status and health of the individual, will have clear benefits. This could have profound effects on preventative T2DM management, as well as current T2DM care without excessive cost for the wider Saudi health economy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

3.3 years

First QC Date

January 1, 2013

Last Update Submit

February 26, 2019

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • effects of probiotics on endotoxin levels in patients with T2DM

    Exploration of baseline characteristics and determination of associations between nutritional habits, gut flora and levels of endotoxin/inflammatory markers at baseline and subsequent follow ups

    1 year

Secondary Outcomes (1)

  • effects of probiotics on gut microflora

    1 year

Other Outcomes (1)

  • Effects of probiotics on insulin resistance

    1 year

Study Arms (2)

Probiotics

EXPERIMENTAL

Probitoics

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT

Administration of probiotics daily for 26 weeks and compared to placebo

Also known as: Ecologic Metabolic
Probiotics
PlaceboDIETARY_SUPPLEMENT

Administration of placebo daily for 26 weeks and compared to probiotics group

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable and well controlled T2DM (HbA1c \< 7.5% and no change in oral antidiabetic medications during the last 6 months)
  • Age 20-75 years
  • Provision of written informed consent

You may not qualify if:

  • Chronic gastrointestinal disease (except IBS)
  • Regular intake of insulin or insulin analogs, antibiotics or probiotics, antacids, H2-receptor blockers, proton pump inhibiters, loperamide, cholestryramine, ω3 supplements, fibrates, corticosteroids or sex steroids
  • Daily alcohol consumption \> 30 g
  • Significant immunodeficiency
  • Known cardiac valvular disease
  • Breast-feeding or pregnant
  • Non-Arab ethnicity
  • Participation in another clinical trial within the last 6 months
  • Legal incapability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomarkers Research Program, King Saud university

Riyadh, 11451, Saudi Arabia

Location

Related Publications (3)

  • Sabico S, Al-Mashharawi A, Al-Daghri NM, Wani K, Amer OE, Hussain DS, Ahmed Ansari MG, Masoud MS, Alokail MS, McTernan PG. Effects of a 6-month multi-strain probiotics supplementation in endotoxemic, inflammatory and cardiometabolic status of T2DM patients: A randomized, double-blind, placebo-controlled trial. Clin Nutr. 2019 Aug;38(4):1561-1569. doi: 10.1016/j.clnu.2018.08.009. Epub 2018 Aug 17.

    PMID: 30170781DERIVED

  • Sabico S, Al-Mashharawi A, Al-Daghri NM, Yakout S, Alnaami AM, Alokail MS, McTernan PG. Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naive T2DM patients: a randomized clinical trial. J Transl Med. 2017 Dec 11;15(1):249. doi: 10.1186/s12967-017-1354-x.

    PMID: 29228964DERIVED

  • Alokail MS, Sabico S, Al-Saleh Y, Al-Daghri NM, Alkharfy KM, Vanhoutte PM, McTernan PG. Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2013 Jul 4;14:195. doi: 10.1186/1745-6215-14-195.

    PMID: 23822518DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nasser Al-Daghri, PhD

    King Saud University

    STUDY CHAIR

  • Majed Alokail, PhD

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 1, 2013

First Posted

January 10, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

SA(1)