Effectiveness of Probiotics for the Prevention of Gastrointestinal Toxicity in Children with Leukemia

NCT06560879 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: 2021/030
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Acute lymphoblastic leukemia (ALL) is a common malignant neoplasm in children. Although chemotherapy achieves remission in over 70% of cases, it can cause gastrointestinal toxicity in up to 32.5%. Some studies suggest that administering probiotics reduces this risk, but the evidence remains inconsistent. Objective: To evaluate the effectiveness and safety of administering L. casei, L. rhamnosus or B. bifidum compared to a placebo for the prevention of gastrointestinal toxicity, decreased intestinal permeability, and changes in intestinal microbiota in pediatric patients diagnosed with acute lymphoblastic leukemia receiving chemotherapy. Methods: A total of 120 participants aged 6 to 17 years, diagnosed with ALL and receiving consolidation phase chemotherapy without gastrointestinal comorbidities, will be included. Participants will be administered daily 2 capsules containing either 1) L. casei, 2) L. rhamnosus, 3) B. bifidum or 4) placebo daily for 8 weeks. The clinical status of the participants will be evaluated weekly by the oncology service to determine the presence of gastrointestinal toxicity and adverse events. Changes in intestinal permeability will be assessed by measuring beta-lactoglobulin in a blood sample using the ELISA technique, while changes in the intestinal microbiota will be analyzed by genomic sequencing at baseline and at the end of follow-up. Statistical analysis: Descriptive analysis will use measures of central tendency and dispersion. For quantitative variables, the mean and standard deviation or median with minimum and maximum values will be calculated depending on the distribution type. Frequencies and proportions will be calculated for qualitative variables, presented in tabular and graphical form. To compare the quantitative variables between the four interventions, a multi-way ANOVA test will be used. The risk of gastrointestinal toxicity and adverse events will be analyzed by calculating the relative risk and 95% confidence interval. Differences between the interventions will be analyzed using survival analysis with the Kaplan-Meier and Log-Rank tests. Sequencing data will be analyzed using the Qiime2 program, filtered to generate a phylogenetic tree using the Silva database. Corresponding plots will be generated for each taxonomic level. Alpha (intra-group) and Beta (inter-group) diversity will be presented by ordination plots using principal component analysis with the ANCOM program

Conditions

Probiotics; Gastrointestinal Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Outcome Measures

Primary Outcomes (7)

• Prevention of Mucositis

  Inflammation of the oral mucosa and gastrointestinal tract, triggered by the activation of inflammatory cytokines. For the evaluation, the pediatric oncologist will perform the physical examination of the oral cavity and report his findings as follows: * Number of participants with mucositis * Participants with mucositis will be evaluated with: A) The number and location of lesion(s). B) The maximum diameter of the largest lesion in centimeters. C) The severity of lesions Grade 1: Mucosal erythema, preserved feeding Grade 2: Focal pseudomembranous ulceration, modified food intake Grade 3: Confluent pseudomembranous ulcers, bleeding with minimal trauma, inability to feed or hydrate. Grade 4: Tissue necrosis, significant spontaneous bleeding

  8 weeks

• Prevention of Diarrhea

  Increase in stool frequency or a decrease in stool consistency. For the evaluation, the pediatric oncologist will question the participant about the characteristics of the bowel movements and perform a physical examination of the abdomen. His findings will be reported as follows: The findings will be recorded as follows: * Number of participants with diarrhea * Participants with diarrhea will be evaluated with: A) Number of bowel movements per day B) Duration of diarrhea in days C) Stool content: None, blood, mocus, fat, food D) Classification of the diarrhea episode: Grade 1: Fewer than 4 stools per day. Grade 2: 4 to 6 stools per day, requiring intravenous hydration for less than 24 hours. Grade 3: More than 7 stools per day, requiring IV hydration for more than 24 hours, and necessitating hospitalization. Grade 4: Severe dehydration with hemodynamic consequences, requiring urgent IV hydration.

  8 weeks

• Prevention of Colitis

  Inflammation and edema of the intestinal mucosa accompanied by abdominal pain, watery and bloody diarrhea. For the evaluation, the pediatric oncologist and pediatric surgeon, will perform a physical examination, laboratory and imaging studies. Findings will be recorded as follows: * Number of participants with colitis * Participants with colitis will be assessed with: A) Pain intensity using a visual analog scale (0 = no pain to 10 = severe pain). B) Location of pain (generalized or in one or more of the 9 abdominal regions) C) Duration of abdominal pain in days D) Classification of colitis: Grade 1 = asymptomatic Grade 2 = abdominal pain, presence of mucus or blood on evacuation Grade 3 = abdominal pain, fever, changes in evacuation rhythm with ileus or signs of peritoneal irritation. Grade 4 = Intestinal perforation, ischemia, hemorrhage, toxic megacolon or intestinal necrosis.

  8 weeks

• Adverse events (flatulence)

  Production of intestinal gas mixture that is expelled through the rectum. For evaluation, the pediatric oncologist will ask the participant if there has been an increase in the frequency and amount of intestinal gas production during the week, and depending on the characteristics of the abdomen, flatulence will be classified according to the number of gases expelled per day. The findings will be recorded as follows: \- Number of participants with gas. Absence \< 25 gases per day Presence \> 25 gases per day

  8 weeks

• Adverse events (distention)

  Increased abdominal girth due to excessive gas in the bowel For evaluation, the pediatric oncologist will ask the participant if he/she has had an increase in abdominal girth during the week and will measure the abdominal girth using a circumference tape placed around the midpoint between the lower edge of the last rib and the upper edge of the iliac crest without applying pressure and will ask the participant to take a deep breath and at the moment of exhalation the measurement will be taken in centimeters.

  8 weeks

• Adverse events (constipation)

  Infrequent bowel movements accompanied by scanty and hard stools. For evaluation, the pediatric oncologist and pediatric surgeon will ask the participant if has had difficulty passing stools during the week and will perform a physical examination. The findings will be recorded as follows: * Number of participants with constipation absent = \> 1 defecation per day present \< 1 defecation per day * Participants with constipation will be assessed with: A) Frequency of defecation per week B) Length of constipation in days C) Classification of constipation: Grade 1 = occasional or intermittent symptoms, sporadic use of laxatives, dietary changes, or need for enemas. Grade 2 = persistent symptoms with frequent use of laxatives or enemas Grade 3 = symptoms interfere with activities of daily living and require manual bowel movements Grade 4 = risk of death from bowel obstruction or toxic megacolon

  8 weeks

• Adverse events (vomiting)

  Violent expulsion of gastric contents by mouth. To assess this, the pediatric oncologist will ask the participant if he/she has experienced this during the week. The findings will be recorded as follows: * Number of participants who vomited absent present \> 1 event per day * Participants with vomiting will be assessed with: A) Frequency of vomiting per day. B) Duration of vomiting C) Volume of vomiting D) Content of vomiting: * water * blood * mucus * food

  8 weeks

Secondary Outcomes (4)

• Blood Beta-Lactoglobulin Concentration

  8 weeks

• Changes in alpha and beta diversity of the intestinal microbiota

  8 weeks

• Adverse events (fever)

  8 weeks

• Adverse events (nausea)

  8 weeks

Study Arms (4)

Lactobacillus casei

EXPERIMENTAL

Oral administration of 1 capsule with Lactobacillus casei (2.5 billion CFU + microcrystalline cellulose) before breakfast and another capsule before lunch, for a total dose of 5 billion CFU/day.

Biological: Lactobacillus casei

Lactobacillus rhamnosus

EXPERIMENTAL

Oral administration of 1 capsule with Lactobacillus rhamnosus (2.5 billion CFU + microcrystalline cellulose) before breakfast and another capsule before lunch, for a total dose of 5 billion CFU/day.

Biological: Lactobacillus rhamnosus

Bifidobacterium bifidum

EXPERIMENTAL

Oral administration of 1 capsule with Bifidobacterium bifidum (1 billion CFU + microcrystalline cellulose) before breakfast and another capsule before lunch, for a total dose of 2 billion CFU/day.

Biological: Bifidobacterium bifidum

Placebo

PLACEBO COMPARATOR

Oral administration of 1 capsule of 300 mg of microcrystalline cellulose before breakfast and another before lunch (600 mg/day).

Dietary Supplement: Placebo

Interventions

Lactobacillus casei BIOLOGICAL

Lacticaseibacillus casei is a species of Gram-positive anaerobic bacteria found in the intestine and mouth of humans. This lactic acid-producing bacterium is used in the dairy industry in the production of probiotic foods.

Lactobacillus casei

Lactobacillus rhamnosus BIOLOGICAL

A live form of a bacterium that makes lactic acid (a substance derived from milk sugars and also made by the body). Lactobacillus rhamnosus GG is given to help with digestion and normal bowel function. In addition, it may help maintain a healthy gastrointestinal tract. It is being studied for the prevention of infections in patients who received donor stem cell transplants and for other conditions.

Lactobacillus rhamnosus

Bifidobacterium bifidum BIOLOGICAL

B. bifidum is an essential bacteria found in the human intestine. When it is low or absent all together in the human intestine, it is an indication of being in an unhealthy state. Intestinal flora can be improved if someone takes oral B. bifidum. Also, oral B. bifidum is used for other things such as therapy for enteric and hepatic disorders, for activating the immune response, and for preventing some cancers

Bifidobacterium bifidum

Placebo DIETARY_SUPPLEMENT

Microcrystalline cellulose is a term for refined wood pulp and is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production.The most common form is used in vitamin supplements or tablets

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients older than 6 years and younger than 17 years with a recent diagnosis of acute lymphoblastic leukemia, confirmed by bone marrow aspirate and interpreted by a pediatric oncologist.
• Participants of both sexes
• Participants receiving treatment at the Oncology Service of the Instituto Nacional de Pediatría.
• Receiving chemotherapy according to national health protocols in the consolidation phase.
• Informed consent
• Informed assent for those older than 8 years.

You may not qualify if:

• Allergy to probiotics.
• Consumption of another probiotic
• Enteropathies affecting intestinal absorption (e.g., malabsorption syndrome, short bowel syndrome, intestinal malrotation, chronic nonspecific ulcerative colitis, Crohn's disease).
• Chronic diarrhea (\>15 days of duration)
• Presence of mucosal lesions
• Impossibility of enteral feeding
• Renal insufficiency
• Peritoneal dialysis
• Water and electrolyte disorders
• Surgical intestinal bypass (e.g., colostomy, ileostomy)
• Congenital metabolic disorders
• Septicemia
• Body temperature \> 38° C
• Received broad-spectrum antibiotics (piperacillin/tazobactam, fourth generation cephalosporins, aminoglycosides, carbapenem and/or metronidazole) within the past 30 days.

Sponsors & Collaborators

• National Institute of Pediatrics, Mexico: lead

Study Sites (1)

National Institute of Pediatrics

Mexico City, Coyoacan, 04530, Mexico

Location

Related Publications (31)

• Pui CH, Evans WE. Acute lymphoblastic leukemia. N Engl J Med. 1998 Aug 27;339(9):605-15. doi: 10.1056/NEJM199808273390907. No abstract available.

  PMID: 9718381 BACKGROUND

• Pui CH, Campana D, Pei D, Bowman WP, Sandlund JT, Kaste SC, Ribeiro RC, Rubnitz JE, Raimondi SC, Onciu M, Coustan-Smith E, Kun LE, Jeha S, Cheng C, Howard SC, Simmons V, Bayles A, Metzger ML, Boyett JM, Leung W, Handgretinger R, Downing JR, Evans WE, Relling MV. Treating childhood acute lymphoblastic leukemia without cranial irradiation. N Engl J Med. 2009 Jun 25;360(26):2730-41. doi: 10.1056/NEJMoa0900386.

  PMID: 19553647 BACKGROUND

• Rivera-Luna R, Velasco-Hidalgo L, Zapata-Tarres M, Cardenas-Cardos R, Aguilar-Ortiz MR. Current outlook of childhood cancer epidemiology in a middle-income country under a public health insurance program. Pediatr Hematol Oncol. 2017 Feb;34(1):43-50. doi: 10.1080/08880018.2016.1276236. Epub 2017 Mar 13.

  PMID: 28287336 BACKGROUND

• Moricke A, Zimmermann M, Valsecchi MG, Stanulla M, Biondi A, Mann G, Locatelli F, Cazzaniga G, Niggli F, Arico M, Bartram CR, Attarbaschi A, Silvestri D, Beier R, Basso G, Ratei R, Kulozik AE, Lo Nigro L, Kremens B, Greiner J, Parasole R, Harbott J, Caruso R, von Stackelberg A, Barisone E, Rossig C, Conter V, Schrappe M. Dexamethasone vs prednisone in induction treatment of pediatric ALL: results of the randomized trial AIEOP-BFM ALL 2000. Blood. 2016 Apr 28;127(17):2101-12. doi: 10.1182/blood-2015-09-670729. Epub 2016 Feb 17.

  PMID: 26888258 BACKGROUND

• Barry E, Alvarez JA, Scully RE, Miller TL, Lipshultz SE. Anthracycline-induced cardiotoxicity: course, pathophysiology, prevention and management. Expert Opin Pharmacother. 2007 Jun;8(8):1039-58. doi: 10.1517/14656566.8.8.1039.

  PMID: 17516870 BACKGROUND

• Schmiegelow K, Muller K, Mogensen SS, Mogensen PR, Wolthers BO, Stoltze UK, Tuckuviene R, Frandsen T. Non-infectious chemotherapy-associated acute toxicities during childhood acute lymphoblastic leukemia therapy. F1000Res. 2017 Apr 7;6:444. doi: 10.12688/f1000research.10768.1. eCollection 2017.

  PMID: 28413626 BACKGROUND

• Gorschluter M, Marklein G, Hofling K, Clarenbach R, Baumgartner S, Hahn C, Ziske C, Mey U, Heller R, Eis-Hubinger AM, Sauerbruch T, Schmidt-Wolf IG, Glasmacher A. Abdominal infections in patients with acute leukaemia: a prospective study applying ultrasonography and microbiology. Br J Haematol. 2002 May;117(2):351-8. doi: 10.1046/j.1365-2141.2002.03434.x.

  PMID: 11972517 BACKGROUND

• Inaba H, Pei D, Wolf J, Howard SC, Hayden RT, Go M, Varechtchouk O, Hahn T, Buaboonnam J, Metzger ML, Rubnitz JE, Ribeiro RC, Sandlund JT, Jeha S, Cheng C, Evans WE, Relling MV, Pui CH. Infection-related complications during treatment for childhood acute lymphoblastic leukemia. Ann Oncol. 2017 Feb 1;28(2):386-392. doi: 10.1093/annonc/mdw557.

  PMID: 28426102 BACKGROUND

• Ribeiro ILA, Limeira RRT, Dias de Castro R, Ferreti Bonan PR, Valenca AMG. Oral Mucositis in Pediatric Patients in Treatment for Acute Lymphoblastic Leukemia. Int J Environ Res Public Health. 2017 Nov 28;14(12):1468. doi: 10.3390/ijerph14121468.

  PMID: 29182564 BACKGROUND

• Raja RA, Schmiegelow K, Albertsen BK, Prunsild K, Zeller B, Vaitkeviciene G, Abrahamsson J, Heyman M, Taskinen M, Harila-Saari A, Kanerva J, Frandsen TL; Nordic Society of Paediatric Haematology and Oncology (NOPHO) group. Asparaginase-associated pancreatitis in children with acute lymphoblastic leukaemia in the NOPHO ALL2008 protocol. Br J Haematol. 2014 Apr;165(1):126-33. doi: 10.1111/bjh.12733. Epub 2014 Jan 15.

  PMID: 24428625 BACKGROUND

• Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, Green DM, Armstrong GT, Nottage KA, Jones KE, Sklar CA, Srivastava DK, Robison LL. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013 Jun 12;309(22):2371-2381. doi: 10.1001/jama.2013.6296.

  PMID: 23757085 BACKGROUND

• Strauss AJ, Su JT, Dalton VM, Gelber RD, Sallan SE, Silverman LB. Bony morbidity in children treated for acute lymphoblastic leukemia. J Clin Oncol. 2001 Jun 15;19(12):3066-72. doi: 10.1200/JCO.2001.19.12.3066.

  PMID: 11408503 BACKGROUND

• Zawitkowska J, Lejman M, Zaucha-Prazmo A, Drabko K, Plonowski M, Bulsa J, Romiszewski M, Mizia-Malarz A, Koltan A, Derwich K, Karolczyk G, Ociepa T, Cwiklinska M, Trelinska J, Owoc-Lempach J, Niedzwiecki M, Kiermasz A, Kowalczyk J. Grade 3 and 4 Toxicity Profiles During Therapy of Childhood Acute Lymphoblastic Leukemia. In Vivo. 2019 Jul-Aug;33(4):1333-1339. doi: 10.21873/invivo.11608.

  PMID: 31280227 BACKGROUND

• Boussios S, Pentheroudakis G, Katsanos K, Pavlidis N. Systemic treatment-induced gastrointestinal toxicity: incidence, clinical presentation and management. Ann Gastroenterol. 2012;25(2):106-118.

  PMID: 24713845 BACKGROUND

• Ruiz-Esquide G, Nervi B, Vargas A, Maiz A. [Treatment and prevention of cancer treatment related oral mucositis]. Rev Med Chil. 2011 Mar;139(3):373-81. Epub 2011 Aug 25. Spanish.

  PMID: 21879172 BACKGROUND

• Moscardo Guilleme C, Fernandez Delgado R, Sevilla Navarro J, Astigarraga Aguirre I, Rives Sola S, Sanchez de Toledo Codina J, Fuster Soler JL, Parra Ramirez L, Molina Garicano J, Gonzalez Martinez B, Madero Lopez L. [Update on L-asparaginase treatment in paediatrics]. An Pediatr (Barc). 2013 Nov;79(5):329.e1-329.e11. doi: 10.1016/j.anpedi.2013.03.015. Epub 2013 May 31. Spanish.

  PMID: 23727426 BACKGROUND

• El-Mahallawy HA, El-Din NH, Salah F, El-Arousy M, El-Naga SA. Epidemiologic profile of symptomatic gastroenteritis in pediatric oncology patients receiving chemotherapy. Pediatr Blood Cancer. 2004 Apr;42(4):338-42. doi: 10.1002/pbc.10394.

  PMID: 14966830 BACKGROUND

• Maroun JA, Anthony LB, Blais N, Burkes R, Dowden SD, Dranitsaris G, Samson B, Shah A, Thirlwell MP, Vincent MD, Wong R. Prevention and management of chemotherapy-induced diarrhea in patients with colorectal cancer: a consensus statement by the Canadian Working Group on Chemotherapy-Induced Diarrhea. Curr Oncol. 2007 Feb;14(1):13-20. doi: 10.3747/co.2007.96.

  PMID: 17576459 BACKGROUND

• Ahern PP, Maloy KJ. Understanding immune-microbiota interactions in the intestine. Immunology. 2020 Jan;159(1):4-14. doi: 10.1111/imm.13150. Epub 2019 Nov 27.

  PMID: 31777071 BACKGROUND

• Icaza-Chavez ME. [Gut microbiota in health and disease]. Rev Gastroenterol Mex. 2013 Oct-Dec;78(4):240-8. doi: 10.1016/j.rgmx.2013.04.004. Epub 2013 Nov 28. Spanish.

  PMID: 24290319 BACKGROUND

• Hawrelak JA, Myers SP. The causes of intestinal dysbiosis: a review. Altern Med Rev. 2004 Jun;9(2):180-97.

  PMID: 15253677 BACKGROUND

• Forsgard RA, Marrachelli VG, Korpela K, Frias R, Collado MC, Korpela R, Monleon D, Spillmann T, Osterlund P. Chemotherapy-induced gastrointestinal toxicity is associated with changes in serum and urine metabolome and fecal microbiota in male Sprague-Dawley rats. Cancer Chemother Pharmacol. 2017 Aug;80(2):317-332. doi: 10.1007/s00280-017-3364-z. Epub 2017 Jun 23.

  PMID: 28646338 BACKGROUND

• Hakim H, Dallas R, Wolf J, Tang L, Schultz-Cherry S, Darling V, Johnson C, Karlsson EA, Chang TC, Jeha S, Pui CH, Sun Y, Pounds S, Hayden RT, Tuomanen E, Rosch JW. Gut Microbiome Composition Predicts Infection Risk During Chemotherapy in Children With Acute Lymphoblastic Leukemia. Clin Infect Dis. 2018 Aug 1;67(4):541-548. doi: 10.1093/cid/ciy153.

  PMID: 29518185 BACKGROUND

• Touchefeu Y, Montassier E, Nieman K, Gastinne T, Potel G, Bruley des Varannes S, Le Vacon F, de La Cochetiere MF. Systematic review: the role of the gut microbiota in chemotherapy- or radiation-induced gastrointestinal mucositis - current evidence and potential clinical applications. Aliment Pharmacol Ther. 2014 Sep;40(5):409-21. doi: 10.1111/apt.12878. Epub 2014 Jul 11.

  PMID: 25040088 BACKGROUND

• Reyna-Figueroa J, Barron-Calvillo E, Garcia-Parra C, Galindo-Delgado P, Contreras-Ochoa C, Lagunas-Martinez A, Campos-Romero FH, Silva-Estrada JA, Limon-Rojas AE. Probiotic Supplementation Decreases Chemotherapy-induced Gastrointestinal Side Effects in Patients With Acute Leukemia. J Pediatr Hematol Oncol. 2019 Aug;41(6):468-472. doi: 10.1097/MPH.0000000000001497.

  PMID: 31033786 BACKGROUND

• Wei D, Heus P, van de Wetering FT, van Tienhoven G, Verleye L, Scholten RJ. Probiotics for the prevention or treatment of chemotherapy- or radiotherapy-related diarrhoea in people with cancer. Cochrane Database Syst Rev. 2018 Aug 31;8(8):CD008831. doi: 10.1002/14651858.CD008831.pub3.

  PMID: 30168576 BACKGROUND

• Alexander JL, Wilson ID, Teare J, Marchesi JR, Nicholson JK, Kinross JM. Gut microbiota modulation of chemotherapy efficacy and toxicity. Nat Rev Gastroenterol Hepatol. 2017 Jun;14(6):356-365. doi: 10.1038/nrgastro.2017.20. Epub 2017 Mar 8.

  PMID: 28270698 BACKGROUND

• Redman MG, Ward EJ, Phillips RS. The efficacy and safety of probiotics in people with cancer: a systematic review. Ann Oncol. 2014 Oct;25(10):1919-1929. doi: 10.1093/annonc/mdu106. Epub 2014 Mar 11.

  PMID: 24618152 BACKGROUND

• Lu D, Yan J, Liu F, Ding P, Chen B, Lu Y, Sun Z. Probiotics in preventing and treating chemotherapy-induced diarrhea: a meta-analysis. Asia Pac J Clin Nutr. 2019;28(4):701-710. doi: 10.6133/apjcn.201912_28(4).0005.

  PMID: 31826366 BACKGROUND

• Rodriguez JM, Murphy K, Stanton C, Ross RP, Kober OI, Juge N, Avershina E, Rudi K, Narbad A, Jenmalm MC, Marchesi JR, Collado MC. The composition of the gut microbiota throughout life, with an emphasis on early life. Microb Ecol Health Dis. 2015 Feb 2;26:26050. doi: 10.3402/mehd.v26.26050. eCollection 2015.

  PMID: 25651996 BACKGROUND

• Van den Nieuwboer M, Brummer RJ, Guarner F, Morelli L, Cabana M, Claasen E. The administration of probiotics and synbiotics in immune compromised adults: is it safe? Benef Microbes. 2015 Mar;6(1):3-17. doi: 10.3920/BM2014.0079.

  PMID: 25304690 BACKGROUND

Related Links

• Cancer Stat Facts: Leukemia

MeSH Terms

Conditions

Gastrointestinal Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Digestive System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sara Espinosa-Padilla, Ph.D.

  National Institute of Pediatrics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Interventions packaged in identical, odorless, tasteless, opaque capsules; stored in identical white plastic bottles.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: An experimental, longitudinal, prospective, prolective, analytical, concurrent, randomized, triple-blind: randomized controlled clinical trial

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 19, 2024
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)