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They are major genera of bacteria that make up the colon flora in human, constitute intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal barrier and modulate local and systemic immune responses. Changes in gut microbiota can influence the immune system by increasing gut permeability, intestinal inflammation, and impaired oral tolerance in type 1 diabetes.Taken together, the data imply that bacteriotherapy may potentially be used as a tool to modulate the immune system for preventing islet destruction. Supplementation of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 improved blood glucose control in normoglycaemic pregnant women and reduced the frequency of gestational diabetes mellitus
Aim of the study:
The effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomized, double blind, placebo-controlled trial.
Primary end point:
Area under the curve (AUC) of c-peptide level during during fasting and at 30,60,90,120 min following the start of the meal
Intervention:
Included patients will be randomly assigned to receive a combination of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 (Probiotics Group ) or placebo (Placebo Group ) during six months.
The expected results:
Beneficial effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell function shown in the properly performed, methodologically accurate study would create a rationale for its routine use in patients with newly diagnosed type 1 diabetes.
Intervention:
At the 6-month follow-up visit will be evaluated adherence and occurrence of side effects of the study procedure. The outcome measures will be assessed at the beginning of the study, and at the 6 and 12-month follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics arm: Probiotics group | Experimental | combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule |
|
| Placebo arm: Placebo group | Placebo Comparator | Placebo - maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 | Drug | Combination therapy of probiotics during 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal | 120 min responses to a mixed meal |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin requirement (U / kg body mass ) | up 60 days from diabetes recognition, at 3th, 6th, 12th month | |
| HbA1c | up to 60 days from diabetes recognition, at 3th, 6th, 12th month | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnieszka Szypowska, Assoc. Prof. | Contact | +48 509928617 | agnieszka.szypowska@gmail.com | |
| Lidia Groele, PhD | Contact | +48 608 671 083 | lgroele@wp.pl |
| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Szypowska, Assoc. Prof. | Medical University of Warsaw | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21709219 | Background | Kriegel MA, Sefik E, Hill JA, Wu HJ, Benoist C, Mathis D. Naturally transmitted segmented filamentous bacteria segregate with diabetes protection in nonobese diabetic mice. Proc Natl Acad Sci U S A. 2011 Jul 12;108(28):11548-53. doi: 10.1073/pnas.1108924108. Epub 2011 Jun 27. | |
| 22688329 | Background | Greenbaum CJ, Beam CA, Boulware D, Gitelman SE, Gottlieb PA, Herold KC, Lachin JM, McGee P, Palmer JP, Pescovitz MD, Krause-Steinrauf H, Skyler JS, Sosenko JM; Type 1 Diabetes TrialNet Study Group. Fall in C-peptide during first 2 years from diagnosis: evidence of at least two distinct phases from composite Type 1 Diabetes TrialNet data. Diabetes. 2012 Aug;61(8):2066-73. doi: 10.2337/db11-1538. Epub 2012 Jun 11. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Not provided
| ID | Term |
|---|---|
| D019936 | Probiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo, (Placebo group) | Other | Placebo during 6 months |
|
|
| Weight in kilograms |
| up to 60 days from diabetes recognition, and at 3th, 6th, 12th month |
| Number of participants with abnormal laboratory values and/or adverse events that are related to treatment ( eg.abdominal pain, diarrhea , constipation , vomiting,flatulence) | at 3th, 6th, 12th month |
| Occurrence of other autoimmune diseases | at 12th month |
| Height in meters | up to 60 days from diabetes recognition, and at 3th, 6th, 12th month |
| BMI in kg/m2 | up to 60 days from diabetes recognition, and at 3th, 6th, 12th month |
| BMI score | up to 60 days from diabetes recognition, and at 3th, 6th, 12th month |
| severe hypoglycemia | up to 60 days from diabetes recognition, at 3th, 6th, 12th month |
| ketoacidosis | up to 60 days from diabetes recognition, at 3th, 6th, 12th month |
| Fasting c- peptide concentrations in ng/ml | up to 60 days from diabetes recognition, and in: 6th, 12th month |
| 9518395 | Background | Effect of intensive therapy on residual beta-cell function in patients with type 1 diabetes in the diabetes control and complications trial. A randomized, controlled trial. The Diabetes Control and Complications Trial Research Group. Ann Intern Med. 1998 Apr 1;128(7):517-23. doi: 10.7326/0003-4819-128-7-199804010-00001. |
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| 19017418 | Background | Laitinen K, Poussa T, Isolauri E; Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota Group. Probiotics and dietary counselling contribute to glucose regulation during and after pregnancy: a randomised controlled trial. Br J Nutr. 2009 Jun;101(11):1679-87. doi: 10.1017/S0007114508111461. Epub 2008 Nov 19. |
| 20128938 | Background | Luoto R, Laitinen K, Nermes M, Isolauri E. Impact of maternal probiotic-supplemented dietary counselling on pregnancy outcome and prenatal and postnatal growth: a double-blind, placebo-controlled study. Br J Nutr. 2010 Jun;103(12):1792-9. doi: 10.1017/S0007114509993898. Epub 2010 Feb 4. |
| 21646390 | Result | Badami E, Sorini C, Coccia M, Usuelli V, Molteni L, Bolla AM, Scavini M, Mariani A, King C, Bosi E, Falcone M. Defective differentiation of regulatory FoxP3+ T cells by small-intestinal dendritic cells in patients with type 1 diabetes. Diabetes. 2011 Aug;60(8):2120-4. doi: 10.2337/db10-1201. Epub 2011 Jun 6. |
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| 33771763 | Derived | Groele L, Szajewska H, Szalecki M, Swiderska J, Wysocka-Mincewicz M, Ochocinska A, Stelmaszczyk-Emmel A, Demkow U, Szypowska A. Lack of effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e001523. doi: 10.1136/bmjdrc-2020-001523. |
| 29025837 | Derived | Groele L, Szajewska H, Szypowska A. Effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: protocol of a randomised controlled trial. BMJ Open. 2017 Oct 11;7(10):e017178. doi: 10.1136/bmjopen-2017-017178. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019602 |
| Food and Beverages |