Symbiotic Use in Post-Bariatric Surgery Patients

NCT ID: NCT06252558

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this double blind, randomized control trial would be to test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients by testing stool samples prior to administration and then three months post administration of the symbiotic to monitor any changes in bacteria in the stool samples. Study participants will also complete a survey that evaluates their bowel habits, stool consistency, and gastrointestinal related symptoms.

Detailed Description

The topic of interest is the gut microbiome and the impact of symbiotics (prebiotics coupled with probiotics) on gut health after weight loss surgeries due to surgical alterations of the stomach and bowels as a result of the procedures. Symbiotics provide positive gut health benefits, ie. improvement in bowel function and reduction in gastrointestinal distress symptoms such as bloating. However, when conducting a literature review on probiotics/prebiotics, most of the research studies have poor quality and do not cite the quantity of each strain being studied. To date, no research has been conducted on symbiotic administration in post bariatric surgery patients and their relationship regarding improvements in gastrointestinal symptoms.

There is no standard dose recommended for probiotics. Each strain should be given at a dose that has shown to be effective at providing a health benefit to the host through clinical trials. However, no clear criteria has been established to determine what classifies as effective and what health benefits are considered clinically relevant. Most healthcare organizations recommend between 1 to 20 x 109 colony forming units (CFU)/ day for adults. In many cases, higher dosages have been shown to be more effective, but a clear dose-dependent response has not been identified and a "more is better" philosophy does not apply to all strains. Therefore, one rule states that "If a product contains multiple strains, then each strain should be present at levels of 109 to ensure effectiveness."

The primary objective of this study would be to determine the efficacy of symbiotic administration for improving gastrointestinal health in weight loss surgery patients. This study would test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients, twelve months or greater post-surgery, by testing stool samples prior to administration and then three months after administration of the symbiotic to monitor any changes in bacteria in the stool samples. Study participants will also complete a survey that evaluates their bowel habits, stool consistency, and gastrointestinal symptoms prior and post symbiotic administration.

Conditions

Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Symbiotic Group

An over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic.

Group Type: EXPERIMENTAL

Symbiotic

Intervention Type: DIETARY_SUPPLEMENT

One-a-day administration of a capsule supplement containing:15 billion CFU probiotic blend (Lactobacillus acidophilus La-14, Bifidobacterium longum BB536, Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus GG, Lactobacillus gasseri Lg-36) and 250mg of chicory root inulin.

Fiber Group

Once daily capsule of microcrystalline cellulose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily fiber capsule containing microcrystalline cellulose

Interventions

Symbiotic

One-a-day administration of a capsule supplement containing:15 billion CFU probiotic blend (Lactobacillus acidophilus La-14, Bifidobacterium longum BB536, Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus GG, Lactobacillus gasseri Lg-36) and 250mg of chicory root inulin.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily fiber capsule containing microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Celebrate Balance Probiotic Plus Prebiotic

Eligibility Criteria

Inclusion Criteria

• 12 months or greater post malabsorptive weight loss procedure

Exclusion Criteria

• LapBand or Intra-gastric balloon patients due to lack of surgical alteration to gut
• Individuals who have not had an approved weight loss procedure
• Individuals with impaired gastrointestinal function which would impair ingestion of oral supplement
• Individuals with impaired gastrointestinal function which would impair ability to collect stool sample
• Inability to comprehend and complete assessment tools
• Inability to adhere to 90-day capsule supplement administration
• Currently taking daily probiotic, prebiotic, or symbiotic supplement
• Currently taking antibiotic treatment from physician

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Celebrate Nutritional Supplements

UNKNOWN

Sponsor Role: collaborator

University of North Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of North Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samantha Stavola-Giaconia, MHA

Role: CONTACT

sam@celebratevitamins.com

215-806-2792

Andrea Arikawa, PhD

Role: CONTACT

a.arikawa@unf.edu

904-620-1433

Facility Contacts

Andrea Y Arikawa, PhD

Role: primary

a.arikawa@unf.edu

904-620-1433

Nicole Sayers

Role: backup

irb@unf.edu

904-620-2498

References

Lim Y, Boster J. Obesity and Comorbid Conditions. StatPearls. Published online October 25, 2021. Accessed March 28, 2022. https://www.ncbi.nlm.nih.gov/books/NBK574535/

Reference Type: BACKGROUND

Obesity Medicine Association. AMA Classifies Obesity as a Disease | Obesity Medicine AssociationMain. Published June 19, 2013. Accessed May 2, 2022.

Reference Type: BACKGROUND

Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.

Reference Type: BACKGROUND

PMID: 32487284 (View on PubMed)

Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax C, Long MW, Gortmaker SL. Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity. N Engl J Med. 2019 Dec 19;381(25):2440-2450. doi: 10.1056/NEJMsa1909301.

Reference Type: BACKGROUND

PMID: 31851800 (View on PubMed)

Bhutani S, vanDellen MR, Cooper JA. Longitudinal Weight Gain and Related Risk Behaviors during the COVID-19 Pandemic in Adults in the US. Nutrients. 2021 Feb 19;13(2):671. doi: 10.3390/nu13020671.

Reference Type: BACKGROUND

PMID: 33669622 (View on PubMed)

Kim J, Eisenberg D, Azagury D, Rogers A, Campos GM. American Society for Metabolic and Bariatric Surgery position statement on long-term survival benefit after metabolic and bariatric surgery. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):453-459. doi: 10.1016/j.soard.2015.11.021. Epub 2015 Nov 27.

Reference Type: BACKGROUND

PMID: 26944548 (View on PubMed)

American Society of Metabolic and Bariatric Surgery. Access to Care Fact Sheet. Published 2011. Accessed March 29, 2022. https://asmbs.org/resources/access-to-care-fact-sheet

Reference Type: BACKGROUND

Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, De Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery. Surg Obes Relat Dis. 2022 Dec;18(12):1345-1356. doi: 10.1016/j.soard.2022.08.013. Epub 2022 Oct 21.

Reference Type: BACKGROUND

PMID: 36280539 (View on PubMed)

Carter J, Chang J, Birriel TJ, Moustarah F, Sogg S, Goodpaster K, Benson-Davies S, Chapmon K, Eisenberg D. ASMBS position statement on preoperative patient optimization before metabolic and bariatric surgery. Surg Obes Relat Dis. 2021 Dec;17(12):1956-1976. doi: 10.1016/j.soard.2021.08.024. Epub 2021 Sep 3. No abstract available.

Reference Type: BACKGROUND

PMID: 34629296 (View on PubMed)

Youdim A. Bariatric Surgery. Merck Manual Professional Version. Published August 2021. Accessed April 17, 2022. https://www.merckmanuals.com/professional/nutritional-disorders/obesity-and-the-metabolic-syndrome/bariatric-surgery

Reference Type: BACKGROUND

Stefater MA, Wilson-Perez HE, Chambers AP, Sandoval DA, Seeley RJ. All bariatric surgeries are not created equal: insights from mechanistic comparisons. Endocr Rev. 2012 Aug;33(4):595-622. doi: 10.1210/er.2011-1044. Epub 2012 May 1.

Reference Type: BACKGROUND

PMID: 22550271 (View on PubMed)

Center for Disease Control and Prevention. Adult Obesity Facts. Published September 30, 2021. Accessed March 28, 2022. https://www.cdc.gov/obesity/data/adult.html

Reference Type: BACKGROUND

Owens DK. Interpretation of cost-effectiveness analyses. J Gen Intern Med. 1998 Oct;13(10):716-7. doi: 10.1046/j.1525-1497.1998.00211.x. No abstract available.

Reference Type: BACKGROUND

PMID: 9798822 (View on PubMed)

Weight Management Dietetic Practice Group. Pocket Guide to Bariatric Surgery. Third Edition. (Isom KA, Majumdar MC, eds.).; 2022.

Reference Type: BACKGROUND

International Federation of Surgery for Obesity. Gastric Bypass Surgery. Accessed April 12, 2022. https://www.ifso.com/roux-en-y-gastric-bypass/

Reference Type: BACKGROUND

International Federation of Surgery for Obesity. Biliopancreatic Diversion. Accessed April 12, 2022. https://www.ifso.com/bilio-pancreatic-diversion-with-duodenal-switch/

Reference Type: BACKGROUND

International Federation of Surgery for Obesity. Laparoscopic Single Anastomosis Duodenal-Ileal bypass with Sleeve (SADI-S). Accessed April 12, 2022. https://www.ifso.com/single-anastomosis-duodenal-Ileal-bypass-with-sleeve/

Reference Type: BACKGROUND

Arterburn DE, Telem DA, Kushner RF, Courcoulas AP. Benefits and Risks of Bariatric Surgery in Adults: A Review. JAMA. 2020 Sep 1;324(9):879-887. doi: 10.1001/jama.2020.12567.

Reference Type: BACKGROUND

PMID: 32870301 (View on PubMed)

American Society for Metabolic and Bariatric Surgery. Estimate of Bariatric Surgery Numbers, 2011-2019. Published March 2021. Accessed April 11, 2022.

Reference Type: BACKGROUND

Mechanick JI, Apovian C, Brethauer S, Garvey WT, Joffe AM, Kim J, Kushner RF, Lindquist R, Pessah-Pollack R, Seger J, Urman RD, Adams S, Cleek JB, Correa R, Figaro MK, Flanders K, Grams J, Hurley DL, Kothari S, Seger MV, Still CD. CLINICAL PRACTICE GUIDELINES FOR THE PERIOPERATIVE NUTRITION, METABOLIC, AND NONSURGICAL SUPPORT OF PATIENTS UNDERGOING BARIATRIC PROCEDURES - 2019 UPDATE: COSPONSORED BY AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/AMERICAN COLLEGE OF ENDOCRINOLOGY, THE OBESITY SOCIETY, AMERICAN SOCIETY FOR METABOLIC & BARIATRIC SURGERY, OBESITY MEDICINE ASSOCIATION, AND AMERICAN SOCIETY OF ANESTHESIOLOGISTS - EXECUTIVE SUMMARY. Endocr Pract. 2019 Dec;25(12):1346-1359. doi: 10.4158/GL-2019-0406. Epub 2019 Nov 4.

Reference Type: BACKGROUND

PMID: 31682518 (View on PubMed)

Tabesh MR, Maleklou F, Ejtehadi F, Alizadeh Z. Nutrition, Physical Activity, and Prescription of Supplements in Pre- and Post-bariatric Surgery Patients: a Practical Guideline. Obes Surg. 2019 Oct;29(10):3385-3400. doi: 10.1007/s11695-019-04112-y.

Reference Type: BACKGROUND

PMID: 31367987 (View on PubMed)

Lysen LK, Isreal DA. Nutrition in Weight Management. In: Mahan KL, Escott-Stump S, Raymond JL, eds. Krause's Food and Nutrition Care Process. 13th ed. Elsevier; 2012:462-488.

Reference Type: BACKGROUND

Sherf Dagan S, Goldenshluger A, Globus I, Schweiger C, Kessler Y, Kowen Sandbank G, Ben-Porat T, Sinai T. Nutritional Recommendations for Adult Bariatric Surgery Patients: Clinical Practice. Adv Nutr. 2017 Mar 15;8(2):382-394. doi: 10.3945/an.116.014258. Print 2017 Mar.

Reference Type: BACKGROUND

PMID: 28298280 (View on PubMed)

Sawaya RA, Jaffe J, Friedenberg L, Friedenberg FK. Vitamin, mineral, and drug absorption following bariatric surgery. Curr Drug Metab. 2012 Nov;13(9):1345-55. doi: 10.2174/138920012803341339.

Reference Type: BACKGROUND

PMID: 22746302 (View on PubMed)

Sherf-Dagan S, Buch A, Ben-Porat T, Sakran N, Sinai T. Vitamin E status among bariatric surgery patients: a systematic review. Surg Obes Relat Dis. 2021 Apr;17(4):816-830. doi: 10.1016/j.soard.2020.10.029. Epub 2020 Nov 10.

Reference Type: BACKGROUND

PMID: 33323330 (View on PubMed)

World Gastroenterology Organisation (WGO). WGO Practice Guidelines Probiotics and Prebiotics. February 2017. https://www.worldgastroenterology.org/guidelines/probiotics-and-prebiotics

Reference Type: BACKGROUND

International Scientific Association for Probiotics and Prebiotics. The ISAPP quick guide to probiotics for health professionals: History, efficacy, and safety. December, 2019. https://isappscience.org/for-clinicians/resources/probiotics/#toggle-id-1

Reference Type: BACKGROUND

Sweeney TE, Morton JM. The human gut microbiome: a review of the effect of obesity and surgically induced weight loss. JAMA Surg. 2013 Jun;148(6):563-9. doi: 10.1001/jamasurg.2013.5.

Reference Type: BACKGROUND

PMID: 23571517 (View on PubMed)

Zhang Y, Yan T, Xu C, Yang H, Zhang T, Liu Y. Probiotics Can Further Reduce Waist Circumference in Adults with Morbid Obesity after Bariatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2021 Apr 1;2021:5542626. doi: 10.1155/2021/5542626. eCollection 2021.

Reference Type: BACKGROUND

PMID: 33859706 (View on PubMed)

Wang Y, Wu XT, Chen J. Effect of Probiotic Supplementation on Weight Loss, Inflammatory Factors, and Metabolic Effects in Patients Undergoing Bariatric Surgery. Obes Surg. 2022 May;32(5):1779-1782. doi: 10.1007/s11695-022-05974-5. Epub 2022 Mar 4. No abstract available.

Reference Type: BACKGROUND

PMID: 35243603 (View on PubMed)

Seganfredo FB, Blume CA, Moehlecke M, Giongo A, Casagrande DS, Spolidoro JVN, Padoin AV, Schaan BD, Mottin CC. Weight-loss interventions and gut microbiota changes in overweight and obese patients: a systematic review. Obes Rev. 2017 Aug;18(8):832-851. doi: 10.1111/obr.12541. Epub 2017 May 19.

Reference Type: BACKGROUND

PMID: 28524627 (View on PubMed)

Farup PG, Valeur J. Changes in Faecal Short-Chain Fatty Acids after Weight-Loss Interventions in Subjects with Morbid Obesity. Nutrients. 2020 Mar 18;12(3):802. doi: 10.3390/nu12030802.

Reference Type: BACKGROUND

PMID: 32197409 (View on PubMed)

Zhang H, DiBaise JK, Zuccolo A, Kudrna D, Braidotti M, Yu Y, Parameswaran P, Crowell MD, Wing R, Rittmann BE, Krajmalnik-Brown R. Human gut microbiota in obesity and after gastric bypass. Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2365-70. doi: 10.1073/pnas.0812600106. Epub 2009 Jan 21.

Reference Type: BACKGROUND

PMID: 19164560 (View on PubMed)

Fouladi F, Brooks AE, Fodor AA, Carroll IM, Bulik-Sullivan EC, Tsilimigras MCB, Sioda M, Steffen KJ. The Role of the Gut Microbiota in Sustained Weight Loss Following Roux-en-Y Gastric Bypass Surgery. Obes Surg. 2019 Apr;29(4):1259-1267. doi: 10.1007/s11695-018-03653-y.

Reference Type: BACKGROUND

PMID: 30604078 (View on PubMed)

Zuo HJ, Xie ZM, Zhang WW, Li YR, Wang W, Ding XB, Pei XF. Gut bacteria alteration in obese people and its relationship with gene polymorphism. World J Gastroenterol. 2011 Feb 28;17(8):1076-81. doi: 10.3748/wjg.v17.i8.1076.

Reference Type: BACKGROUND

PMID: 21448362 (View on PubMed)

Woodard GA, Encarnacion B, Downey JR, Peraza J, Chong K, Hernandez-Boussard T, Morton JM. Probiotics improve outcomes after Roux-en-Y gastric bypass surgery: a prospective randomized trial. J Gastrointest Surg. 2009 Jul;13(7):1198-204. doi: 10.1007/s11605-009-0891-x. Epub 2009 Apr 18.

Reference Type: BACKGROUND

PMID: 19381735 (View on PubMed)

Aron-Wisnewsky J, Prifti E, Belda E, Ichou F, Kayser BD, Dao MC, Verger EO, Hedjazi L, Bouillot JL, Chevallier JM, Pons N, Le Chatelier E, Levenez F, Ehrlich SD, Dore J, Zucker JD, Clement K. Major microbiota dysbiosis in severe obesity: fate after bariatric surgery. Gut. 2019 Jan;68(1):70-82. doi: 10.1136/gutjnl-2018-316103. Epub 2018 Jun 13.

Reference Type: BACKGROUND

PMID: 29899081 (View on PubMed)

Calikoglu F, Barbaros U, Uzum AK, Tutuncu Y, Satman I. The Metabolic Effects of Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB) Surgery: a Prospective, Randomized Controlled Study. Obes Surg. 2021 Jan;31(1):215-223. doi: 10.1007/s11695-020-04894-6. Epub 2020 Aug 15.

Reference Type: BACKGROUND

PMID: 32803709 (View on PubMed)

Kazzi F, Daher N, Zimmerman G, Garcia M, Schmidt N, Scharf K. Effect of Bacillius Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy, A Randomized-Controlled Clinical Trial. Altern Ther Health Med. 2021 Jun;27(S1):138-145.

Reference Type: BACKGROUND

PMID: 29874199 (View on PubMed)

Shoaib M, Shehzad A, Omar M, Rakha A, Raza H, Sharif HR, Shakeel A, Ansari A, Niazi S. Inulin: Properties, health benefits and food applications. Carbohydr Polym. 2016 Aug 20;147:444-454. doi: 10.1016/j.carbpol.2016.04.020. Epub 2016 Apr 8.

Reference Type: BACKGROUND

PMID: 27178951 (View on PubMed)

Anderson JW, Baird P, Davis RH Jr, Ferreri S, Knudtson M, Koraym A, Waters V, Williams CL. Health benefits of dietary fiber. Nutr Rev. 2009 Apr;67(4):188-205. doi: 10.1111/j.1753-4887.2009.00189.x.

Reference Type: BACKGROUND

PMID: 19335713 (View on PubMed)

Sinn DH, Song JH, Kim HJ, Lee JH, Son HJ, Chang DK, Kim YH, Kim JJ, Rhee JC, Rhee PL. Therapeutic effect of Lactobacillus acidophilus-SDC 2012, 2013 in patients with irritable bowel syndrome. Dig Dis Sci. 2008 Oct;53(10):2714-8. doi: 10.1007/s10620-007-0196-4. Epub 2008 Feb 15.

Reference Type: BACKGROUND

PMID: 18274900 (View on PubMed)

Maria Remes Troche J, Coss Adame E, Angel Valdovinos Diaz M, Gomez Escudero O, Eugenia Icaza Chavez M, Antonio Chavez-Barrera J, Zarate Mondragon F, Antonio Ruiz Velarde Velasco J, Rafael Aceves Tavares G, Antonio Lira Pedrin M, Cerda Contreras E, Carmona Sanchez RI, Guerra Lopez H, Solana Ortiz R. Lactobacillus acidophilus LB: a useful pharmabiotic for the treatment of digestive disorders. Therap Adv Gastroenterol. 2020 Nov 24;13:1756284820971201. doi: 10.1177/1756284820971201. eCollection 2020.

Reference Type: BACKGROUND

PMID: 33281937 (View on PubMed)

Kailasapathy K, Chin J. Survival and therapeutic potential of probiotic organisms with reference to Lactobacillus acidophilus and Bifidobacterium spp. Immunol Cell Biol. 2000 Feb;78(1):80-8. doi: 10.1046/j.1440-1711.2000.00886.x.

Reference Type: BACKGROUND

PMID: 10651933 (View on PubMed)

Preston K, Krumian R, Hattner J, de Montigny D, Stewart M, Gaddam S. Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 improve quality-of-life and IBS symptoms: a double-blind, randomised, placebo-controlled study. Benef Microbes. 2018 Sep 18;9(5):697-706. doi: 10.3920/BM2017.0105. Epub 2018 Jun 11.

Reference Type: BACKGROUND

PMID: 29888656 (View on PubMed)

Picard C, Fioramonti J, Francois A, Robinson T, Neant F, Matuchansky C. Review article: bifidobacteria as probiotic agents -- physiological effects and clinical benefits. Aliment Pharmacol Ther. 2005 Sep 15;22(6):495-512. doi: 10.1111/j.1365-2036.2005.02615.x.

Reference Type: BACKGROUND

PMID: 16167966 (View on PubMed)

Bouvier M, Meance S, Bouley C, Berta JL, Grimaud JC. Effects of consumption of a milk fermented by the probiotic strain Bifidobacterium animalis DN-173 010 on colonic transit times in healthy humans. Bioscience Microflora 2001; 20: 43-48.

Reference Type: BACKGROUND

Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017 Jan;112(1):145-151. doi: 10.1038/ajg.2016.511. Epub 2016 Nov 15.

Reference Type: BACKGROUND

PMID: 27845337 (View on PubMed)

Kligler B, Cohrssen A. Probiotics. Am Fam Physician. 2008 Nov 1;78(9):1073-8.

Reference Type: BACKGROUND

PMID: 19007054 (View on PubMed)

Probiotics: Fact Sheet for Health Professionals. National Institute of Health Office of Dietary Supplements.

Reference Type: BACKGROUND

Ouwehand AC. A review of dose-responses of probiotics in human studies. Benef Microbes. 2017 Apr 26;8(2):143-151. doi: 10.3920/BM2016.0140. Epub 2016 Dec 23.

Reference Type: BACKGROUND

PMID: 28008787 (View on PubMed)

Other Identifiers

2089663-1

Identifier Type: -

Identifier Source: org_study_id