Safety of VSL#3 in Adult Asthmatics

NCT00852124 | Terminated Phase 1 Results DMC

• 2 other identifiers: HP-000401511R21AT004089-01A1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol. Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily for 3 months. Data will be collected, including age, race, height, and weight, present medications, past medical history with emphasis on signs/symptoms of asthma. On visits to the clinic we will evaluate

• Changes in lung function
• Intestinal permeability
• Intestinal bacteria
• Levels of inflammation in the blood
• Women will have repeat urine pregnancy testing at each clinic visit

Conditions

Asthma

Keywords

Asthma; Probiotic; VSL#3

Outcome Measures

Primary Outcomes (1)

• Safety of VSL#3 in Adults Asthmatics

  Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Packets similar to VSL#3 will be taken 2 X daily but not containing active bacteria

Biological: VSL#3 or placebo

VSL#3

ACTIVE COMPARATOR

Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial) will be taken 2 x daily in food or a cool beverage.

Biological: VSL#3

Interventions

VSL#3 BIOLOGICAL

VSL#3 2 times daily

VSL#3

VSL#3 or placebo BIOLOGICAL

1 packet 2 x daily of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults age 18-64 years old.
• Doctor diagnosis of mild persistent asthma. Persistent asthma is defined by NAEPP guidelines as asthma symptoms (cough/wheeze/dyspnea/exercise limitation)of greater than 2 times/week daytime or greater than 2 times/month at night over the previous month but less than continual and less than 5 nights/week.
• FEV1 greater than 60% predicted for age/gender/race/height based on normative data.
• No unscheduled asthma related health visit in the 1 month prior to enrollment
• School or work days missed less than or equal to 2 in the previous month for asthma.
• Albuterol use less than 8 doses (2 puffs or one neb) in past week.
• Ability to speak and understand English.
• Telephone access.
• Women of childbearing potential must confirm that they will use birth control while in the study and have a negative urine pregnancy screen at baseline.

You may not qualify if:

• Pregnant women, prisoners.
• Chronic illness (other than asthma, allergic rhinitis and eczema) such as renal disease, diabetes, hypertension or terminal disease or abnormal vital signs: T\> 100.3F, HR\>130 bpm, SBP\>155 mmHg, or DBP\>100 mmHg, RR\>25 bpm, or pox\<93% room air.
• Unable to perform spirometry, necessary for lung function assessment.
• Received probiotic in past 6 months.
• Subject or household member has immunosuppression such as HIV, history of organ transplantation, present cancer or chemotherapy, primary immune disease, or is taking an immune modulating drug.
• Severe persistent asthmatics who have continual daily or frequent (greater than 5 nights/week) asthma symptoms and/or FEV1 less than 60% predicted .
• Diarrhea or constipation (symptoms more than once in the past week)
• Unable to feed orally or to consume cornstarch
• Lung disease other than asthma (e.g. COPD, cystic fibrosis, lung cancer, bronchiectasis, interstitial lung disease).
• Subjects at increased risk of developing infective endocarditis such as those with a history of cardiac surgery, IV drug abuse, recent invasive medical procedures or dental work (recent = last month).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (17)

• Bienenstock J, Wiley RE, Neigh GS, Waserman S, Keith P. Probiotics in the management and prevention of atopy. Clin Rev Allergy Immunol. 2002 Jun;22(3):275-85. doi: 10.1007/s12016-002-0012-z. No abstract available.

  PMID: 12043385 BACKGROUND

• Hijazi N, Abalkhail B, Seaton A. Diet and childhood asthma in a society in transition: a study in urban and rural Saudi Arabia. Thorax. 2000 Sep;55(9):775-9. doi: 10.1136/thorax.55.9.775.

  PMID: 10950897 BACKGROUND

• Kalliomaki M, Isolauri E. Role of intestinal flora in the development of allergy. Curr Opin Allergy Clin Immunol. 2003 Feb;3(1):15-20. doi: 10.1097/00130832-200302000-00003.

  PMID: 12582309 BACKGROUND

• Bjorksten B, Naaber P, Sepp E, Mikelsaar M. The intestinal microflora in allergic Estonian and Swedish 2-year-old children. Clin Exp Allergy. 1999 Mar;29(3):342-6. doi: 10.1046/j.1365-2222.1999.00560.x.

  PMID: 10202341 BACKGROUND

• Hijazi Z, Molla AM, Al-Habashi H, Muawad WM, Molla AM, Sharma PN. Intestinal permeability is increased in bronchial asthma. Arch Dis Child. 2004 Mar;89(3):227-9. doi: 10.1136/adc.2003.027680.

  PMID: 14977697 BACKGROUND

• Isolauri E, Salminen S; Nutrition, Allergy, Mucosal Immunology, and Intestinal Microbiota (NAMI) Research Group Report. Probiotics: use in allergic disorders: a Nutrition, Allergy, Mucosal Immunology, and Intestinal Microbiota (NAMI) Research Group Report. J Clin Gastroenterol. 2008 Jul;42 Suppl 2:S91-6. doi: 10.1097/MCG.0b013e3181639a98.

  PMID: 18542035 BACKGROUND

• Kalliomaki M, Salminen S, Poussa T, Isolauri E. Probiotics during the first 7 years of life: a cumulative risk reduction of eczema in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 Apr;119(4):1019-21. doi: 10.1016/j.jaci.2006.12.608. Epub 2007 Feb 7. No abstract available.

  PMID: 17289135 BACKGROUND

• Laitinen K, Kalliomaki M, Poussa T, Lagstrom H, Isolauri E. Evaluation of diet and growth in children with and without atopic eczema: follow-up study from birth to 4 years. Br J Nutr. 2005 Oct;94(4):565-74. doi: 10.1079/bjn20051503.

  PMID: 16197582 BACKGROUND

• Von Ehrenstein OS, Von Mutius E, Illi S, Baumann L, Bohm O, von Kries R. Reduced risk of hay fever and asthma among children of farmers. Clin Exp Allergy. 2000 Feb;30(2):187-93. doi: 10.1046/j.1365-2222.2000.00801.x.

  PMID: 10651770 BACKGROUND

• Noverr MC, Noggle RM, Toews GB, Huffnagle GB. Role of antibiotics and fungal microbiota in driving pulmonary allergic responses. Infect Immun. 2004 Sep;72(9):4996-5003. doi: 10.1128/IAI.72.9.4996-5003.2004.

  PMID: 15321991 BACKGROUND

• Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.

  PMID: 11297958 BACKGROUND

• Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8. doi: 10.1046/j.1365-2222.2000.00948.x.

  PMID: 11122221 BACKGROUND

• Isolauri E, Sutas Y, Kankaanpaa P, Arvilommi H, Salminen S. Probiotics: effects on immunity. Am J Clin Nutr. 2001 Feb;73(2 Suppl):444S-450S. doi: 10.1093/ajcn/73.2.444s.

  PMID: 11157355 BACKGROUND

• Weizman Z, Asli G, Alsheikh A. Effect of a probiotic infant formula on infections in child care centers: comparison of two probiotic agents. Pediatrics. 2005 Jan;115(1):5-9. doi: 10.1542/peds.2004-1815.

  PMID: 15629974 BACKGROUND

• Land MH, Rouster-Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus sepsis associated with probiotic therapy. Pediatrics. 2005 Jan;115(1):178-81. doi: 10.1542/peds.2004-2137.

  PMID: 15629999 BACKGROUND

• Cannon JP, Lee TA, Bolanos JT, Danziger LH. Pathogenic relevance of Lactobacillus: a retrospective review of over 200 cases. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):31-40. doi: 10.1007/s10096-004-1253-y.

  PMID: 15599646 BACKGROUND

• Rinne M, Kalliomaki M, Arvilommi H, Salminen S, Isolauri E. Effect of probiotics and breastfeeding on the bifidobacterium and lactobacillus/enterococcus microbiota and humoral immune responses. J Pediatr. 2005 Aug;147(2):186-91. doi: 10.1016/j.jpeds.2005.03.053.

  PMID: 16126047 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Early termination due to small number of persons recruited before PI relocated.

Results Point of Contact

• Title: Alessio Fasano
• Organization: UMARYLAND

afasano@partners.org

617-726-1450

Study Officials

• Alessio Fasano, M. D.

  MBRC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Mucosal Biology Research Center

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 20, 2023
• Results First Posted: June 10, 2015

Record last verified: 2022-11

Locations

US (1)