Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
NCT ID: NCT04671186
Last Updated: 2023-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2020-09-07
2023-03-01
Brief Summary
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Detailed Description
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The primary endpoint is to assess the effect of probiotic treatment in liver steatosis and fibrosis by assessing with fibroscan using CAP score and TE staging. The higher the CAP score (S1, S2, S3) so worse the steatosis. TE staging (F0-F4), higher the staging indicates worsening of fibrosis.
Secondary endpoints include:
* The rate of decline of ALT over 3 month time interval and through whole study starting at initial diagnosis.
* The rate of decrease in hepatic steatosis and BMI
This study will target pediatric patients with NAFLD. Participants will be new and previously diagnosed NAFLD patients between the ages of 5 years and 18 years.
This is single center study. Investigators will enroll patients from The Division of Pediatric Gastroenterology, Liver Disease and Nutrition.
Participants will be blindly randomized into one of two groups: probiotic or placebo.
Investigators expect the study to run for 1 year from 09/15/2020 to 09/14/2021. Investigators will enroll patients over a 6 month period. After randomization into two separate groups (probiotic vs placebo), Investigators plan to collect data for the subsequent 6 months following enrollment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic group
Probiotic group will receive Lactobacillus rhamnosus strain GG one capsule oral daily (10 billion CFU/day) throughout the study
Culturelle (Lactobacillus rhamnosus strain GG)
Culturelle probiotics are typically sold over the counter as dietary supplements Probiotics group will take 1 capsule of probiotics orally once daily
Placebo Group
Placebo group is to receive placebo oral capsule daily throughout the study.
Placebo
Placebo group will take 1 capsule of placebo orally once daily
Interventions
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Culturelle (Lactobacillus rhamnosus strain GG)
Culturelle probiotics are typically sold over the counter as dietary supplements Probiotics group will take 1 capsule of probiotics orally once daily
Placebo
Placebo group will take 1 capsule of placebo orally once daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Concomitant infectious hepatitis
* Medication use of steroids, methotrexate, metformin, and therapeutic dose of Vit. E
* Recent antibiotic use in last 4 weeks
* Clinically significant weight loss (at least 5% reduction in weight from baseline level \[18\]) on follow up NAFLD patients who were on life style modification intervention
* Cirrhosis (Fibroscan score ≥14.0)\>
5 Years
18 Years
ALL
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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Principal Investigators
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Shari Sheflin-Findling
Role: PRINCIPAL_INVESTIGATOR
Cohen Children's Medical Center
Locations
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Cohen Children's Medical Center
New Hyde Park, New York, United States
Countries
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References
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Wong RJ, Aguilar M, Cheung R, Perumpail RB, Harrison SA, Younossi ZM, Ahmed A. Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting liver transplantation in the United States. Gastroenterology. 2015 Mar;148(3):547-55. doi: 10.1053/j.gastro.2014.11.039. Epub 2014 Nov 25.
Alisi A, Manco M, Vania A, Nobili V. Pediatric nonalcoholic fatty liver disease in 2009. J Pediatr. 2009 Oct;155(4):469-74. doi: 10.1016/j.jpeds.2009.06.014. No abstract available.
Paolella G, Mandato C, Pierri L, Poeta M, Di Stasi M, Vajro P. Gut-liver axis and probiotics: their role in non-alcoholic fatty liver disease. World J Gastroenterol. 2014 Nov 14;20(42):15518-31. doi: 10.3748/wjg.v20.i42.15518.
Vos MB, Abrams SH, Barlow SE, Caprio S, Daniels SR, Kohli R, Mouzaki M, Sathya P, Schwimmer JB, Sundaram SS, Xanthakos SA. NASPGHAN Clinical Practice Guideline for the Diagnosis and Treatment of Nonalcoholic Fatty Liver Disease in Children: Recommendations from the Expert Committee on NAFLD (ECON) and the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). J Pediatr Gastroenterol Nutr. 2017 Feb;64(2):319-334. doi: 10.1097/MPG.0000000000001482.
Comparison of Controlled Attenuation Parameter and Liver Biopsy to Assess Hepatic Steatosis in Pediatric PatientsAuthor links open overlay panel NiravK.DesaiMD1,SarahHarneyBA1,RoshanRazaMD1,AlyaaAlIbraheemiMD2, NickShillingfordMD2, Paul D.MitchellMS3, Maureen M.JonasMD1
Schwimmer JB, Newton KP, Awai HI, Choi LJ, Garcia MA, Ellis LL, Vanderwall K, Fontanesi J. Paediatric gastroenterology evaluation of overweight and obese children referred from primary care for suspected non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1267-77. doi: 10.1111/apt.12518. Epub 2013 Oct 1.
Draijer L, Benninga M, Koot B. Pediatric NAFLD: an overview and recent developments in diagnostics and treatment. Expert Rev Gastroenterol Hepatol. 2019 May;13(5):447-461. doi: 10.1080/17474124.2019.1595589. Epub 2019 Apr 4.
Leung C, Rivera L, Furness JB, Angus PW. The role of the gut microbiota in NAFLD. Nat Rev Gastroenterol Hepatol. 2016 Jul;13(7):412-25. doi: 10.1038/nrgastro.2016.85. Epub 2016 Jun 8.
Lau E, Carvalho D, Freitas P. Gut Microbiota: Association with NAFLD and Metabolic Disturbances. Biomed Res Int. 2015;2015:979515. doi: 10.1155/2015/979515. Epub 2015 May 19.
Ley RE, Backhed F, Turnbaugh P, Lozupone CA, Knight RD, Gordon JI. Obesity alters gut microbial ecology. Proc Natl Acad Sci U S A. 2005 Aug 2;102(31):11070-5. doi: 10.1073/pnas.0504978102. Epub 2005 Jul 20.
Ley RE, Peterson DA, Gordon JI. Ecological and evolutionary forces shaping microbial diversity in the human intestine. Cell. 2006 Feb 24;124(4):837-48. doi: 10.1016/j.cell.2006.02.017.
Henao-Mejia J, Elinav E, Jin C, Hao L, Mehal WZ, Strowig T, Thaiss CA, Kau AL, Eisenbarth SC, Jurczak MJ, Camporez JP, Shulman GI, Gordon JI, Hoffman HM, Flavell RA. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 Feb 1;482(7384):179-85. doi: 10.1038/nature10809.
Mouzaki M, Comelli EM, Arendt BM, Bonengel J, Fung SK, Fischer SE, McGilvray ID, Allard JP. Intestinal microbiota in patients with nonalcoholic fatty liver disease. Hepatology. 2013 Jul;58(1):120-7. doi: 10.1002/hep.26319. Epub 2013 May 14.
Le Roy T, Llopis M, Lepage P, Bruneau A, Rabot S, Bevilacqua C, Martin P, Philippe C, Walker F, Bado A, Perlemuter G, Cassard-Doulcier AM, Gerard P. Intestinal microbiota determines development of non-alcoholic fatty liver disease in mice. Gut. 2013 Dec;62(12):1787-94. doi: 10.1136/gutjnl-2012-303816. Epub 2012 Nov 29.
Alisi A, Bedogni G, Baviera G, Giorgio V, Porro E, Paris C, Giammaria P, Reali L, Anania F, Nobili V. Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2014 Jun;39(11):1276-85. doi: 10.1111/apt.12758. Epub 2014 Apr 16.
Vajro P, Mandato C, Licenziati MR, Franzese A, Vitale DF, Lenta S, Caropreso M, Vallone G, Meli R. Effects of Lactobacillus rhamnosus strain GG in pediatric obesity-related liver disease. J Pediatr Gastroenterol Nutr. 2011 Jun;52(6):740-3. doi: 10.1097/MPG.0b013e31821f9b85.
Ferolla SM, Armiliato GN, Couto CA, Ferrari TC. Probiotics as a complementary therapeutic approach in nonalcoholic fatty liver disease. World J Hepatol. 2015 Mar 27;7(3):559-65. doi: 10.4254/wjh.v7.i3.559.
Swift DL, Johannsen NM, Lavie CJ, Earnest CP, Blair SN, Church TS. Effects of clinically significant weight loss with exercise training on insulin resistance and cardiometabolic adaptations. Obesity (Silver Spring). 2016 Apr;24(4):812-9. doi: 10.1002/oby.21404. Epub 2016 Mar 3.
Patton HM, Yates K, Unalp-Arida A, Behling CA, Huang TT, Rosenthal P, Sanyal AJ, Schwimmer JB, Lavine JE. Association between metabolic syndrome and liver histology among children with nonalcoholic Fatty liver disease. Am J Gastroenterol. 2010 Sep;105(9):2093-102. doi: 10.1038/ajg.2010.152. Epub 2010 Apr 6.
Fusillo S, Rudolph B. Nonalcoholic fatty liver disease. Pediatr Rev. 2015 May;36(5):198-205; quiz 206. doi: 10.1542/pir.36-5-198.
Awai HI, Newton KP, Sirlin CB, Behling C, Schwimmer JB. Evidence and recommendations for imaging liver fat in children, based on systematic review. Clin Gastroenterol Hepatol. 2014 May;12(5):765-73. doi: 10.1016/j.cgh.2013.09.050. Epub 2013 Sep 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20-0198
Identifier Type: -
Identifier Source: org_study_id
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