Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 4:07 AM
Study NCT ID:
NCT04937556
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.', 'timeFrame': '1 month'}, {'measure': 'Duration of the symptoms produced by the SARS-CoV-2 infection', 'timeFrame': '1 month'}, {'measure': 'Severity of symptoms produced during SARS-CoV-2 infection', 'timeFrame': '1 month', 'description': 'Severity of symtoms will be analysed for fever (Tª\\>38ºC) and gastrointestinal symptons (Bristol scale).'}, {'measure': 'Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2', 'timeFrame': '1 month'}, {'measure': 'Percentage of participants with worsening of lower respiratory tract infections', 'timeFrame': '1 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.probisearch.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.\n\nThe study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18-65 years).\n* Mild infection by SARS-CoV-2 detected by PCR or Antigen.\n* Onset of COVID-19 symptoms up to 5 days before the day of inclusion\n* Without hospitalization or oxygen supplementation on the day of inclusion.\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Serious SARS-CoV-2 infection requiring hospitalization or oxygen supply\n* Chronic diseases under regular medication (eg asthma, allergic rhinitis ...)\n* Congenital or acquired immunodeficiency\n* Body Mass Index (BMI)\\> 30\n* Coagulation disorders\n* Short bowel syndrome or any surgery on the gastrointestinal tract.\n* Metabolic disorders (diabetes, etc.).\n* Heart failure and cardiac medical history\n* Pregnant women.\n* HIV positive.\n* Immunocompromised\n* History of significant gastrointestinal diseases\n* Use of other probiotics during the last month.\n* Uncertainty about the willingness or ability of the participant to comply with the requirements of the protocol.'}, 'identificationModule': {'nctId': 'NCT04937556', 'acronym': 'PROVID', 'briefTitle': 'Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProbiSearch SL'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of the Lactobacillus Probiotic Strain in the Immune Response in Participants Positive for SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) Infection.', 'orgStudyIdInfo': {'id': 'COV/21.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic: Lactobacillus salivarius + Vit D + Zinc', 'description': 'Lactobacillus strain during 28 days, approximately 1\\*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day.', 'interventionNames': ['Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo supplement in 1 capsule per day during 28 days.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic: Lactobacillus salivarius + Vit D + Zinc', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A mixture of 1\\*10E9 colony forming unit (CFU) of Lactobacillus salivarius + Vit D + Zinc citrate in 1 capsule will be daily administrated during 28 days.', 'armGroupLabels': ['Probiotic: Lactobacillus salivarius + Vit D + Zinc']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo in 1 capsule will be daily administrated during 28 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProbiSearch SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}