CompletedNot Applicable

Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; A Randomized Clinical Trial

70 participantsStarted 2015-09-10

Plain-language summary

The present study evaluated clinically the effects of a probiotic on oral microbiota and glycemic control in T2 diabetic patients with periodontal disease. The study was designed as a prospective randomized, double-blind, placebo- controlled interventional study. At baseline and at the end of the 30 day- probiotic period, all clinical, microbiological, and biochemical measurements were tested. Colony counts of oral microbiota, blood fructosamine levels and CRP were the outcomes of the study.

Who can participate

Age range

30 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * being diagnosed with T2 diabetes with \<10% HbA1C for at least 6 months, * 30-65 years old patients, * high caries activity patients with Periodontal Disease Index (PDI) scores of 2, 3, 4 and 5, * provision of written informed consent - Exclusion Criteria: * patients regularly using probiotics, * patients on corticosteroid, non-steroid anti-inflammatory, antibiotic or antibacterial mouthwash therapy, * patients with multi-organ deficiency such as liver or kidney failure, * patients with Immunodeficiency syndrome or on immunosuppressive therapy, * patients with heart valve prosthesis or central venous catheter, * patients undergoing chronic or acute disease therapy such as cancer, arthritis, influenza, flu, * legal incapability or mental incapacity to give consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Oral Microbiota colony counts at baseline and after intervention

Timeframe: 30 days

Change in blood fructosamine levels in Type 2 diabetic patients an Oral probiotic use

Timeframe: 30 days

Trial details

NCT IDNCT04913909

SponsorIstanbul University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-18

View on ClinicalTrials.gov More Diabetes Mellitus,Type 2 trials