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Lactobacillus Johnsonii Probiotic for Type 1 Diabetes
Study Summary
This trial suggests that the probiotic Lactobacillus johnsonii N6.2 may help people with type 1 diabetes by preventing or restoring the gut flora and improving adaptive immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing to undergo three 2-hour meal tests.I have taken antibiotics within the last 2 weeks.I am pregnant, breastfeeding, or plan to become pregnant soon.Your blood and overall health tests must be normal, except for fasting glucose and HbA1c tests.I have or am being treated for a condition that weakens my immune system.You currently smoke cigarettes.I am willing to take a daily capsule for 24 weeks.I am taking probiotics and cannot stop them 2 weeks before the study.I have chronic kidney disease.I have or am being treated for a stomach or intestinal disease.My doctor has diagnosed me with Type 1 Diabetes.You are allergic to milk or milk protein.I can swallow pills.I am willing to fill out weekly online questionnaires.I have a heart condition related to the structure of my heart.I am currently on medication for constipation or diarrhea.
- Group 1: Probiotic Group
- Group 2: Placebo Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who is eligible to volunteer for this clinical experiment?
"For this trial, 57 candidates aged 18 to 45 with type 1 diabetes mellitus are being sought. In addition to the age requirement, they must be able swallow a capsule, agree to complete weekly online questionnaires and take daily probiotic or placebo capsules for 24 weeks. Furthermore, participants should expect provide stool samples throughout the study as well as periodic blood tests and three 2-hour Mixed Meal Tolerance Tests (MMTTs)."
What is the total enrollment count for this clinical experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical experiment is currently recruiting patients and has been since February 1st 2020. There have been recent updates made as of July 7th 2022 and the study aims to enroll 57 individuals from a single centre."
Has the Probiotic Group obtained regulatory sanction by the FDA?
"Our evaluation at Power has assigned Probiotic Group a safety score of 2, indicating that the product is safe based on its Phase 2 trial but efficacy data remains inconclusive."
Are any current participants being recruited for this trial?
"The pertinent information on clinicaltrials.gov confirms that this medical experiment, which was initially posted on February 1st 2020, is actively recruiting patients. The trial has been updated as recently as July 7th 2022."
Is the age range for this trial limited to those above 65 years old?
"Prospective participants must be between 18-45 years old for this trial. There are 156 studies targeting those below the age of consent and 177 geared towards seniors aged 65+."
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