Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-05 @ 5:45 PM
Study NCT ID:
NCT03341403
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only Phacobel which provide the pills will have the knowledge of the pills codes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'randomized double blind placebo control study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'blood eosinophil count decrease', 'timeFrame': 'before the administration and 1-3-6 months after the first administration', 'description': 'in absolute value'}, {'measure': 'sputum eosinophil count decrease', 'timeFrame': 'before the administration and 1-3-6 months after the first administration', 'description': 'in absolute value'}, {'measure': 'sputum eosinophil percentage decrease', 'timeFrame': 'before the administration and 1-3-6 months after the first administration', 'description': 'in percentage'}], 'primaryOutcomes': [{'measure': 'ACQ improvement', 'timeFrame': 'before the administration and 1-3-6 months after the first administration', 'description': 'improvement of asthma control. Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). An improvement correspond to a decrease of at least 0.5 compared to the last evaluation.'}], 'secondaryOutcomes': [{'measure': 'exhaled nitric oxide value decrease', 'timeFrame': 'before the administration and 1-3-6 months after the first administration', 'description': 'measure in ppb with a chemoluminescence analyser'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe asthma', 'synbiotic', 'immunomodulation', 'sputum'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://glycocheck.com/', 'label': 'Glycocheck website'}, {'url': 'https://www.interregemr.eu/projects/healthyaging-en', 'label': 'interreg Euregio Meuse Rhine project'}]}, 'descriptionModule': {'briefSummary': 'It is a randomized double blind placebo control study. One hundred severe asthmatic patients will receive "Probiotical ®/Bactecal®" each day during 3 months and will be evaluated before and 1-3-6 months after in order to assess the impact of the synbiotic on the lung function, the exhaled nitric oxide value, the inflammatory blood and sputum profiles, the bronchial reactivity, the microvascular health and the quality of life and asthma control. The hypothesis is that, as these patients are not optimally controlled, the synbiotic could have an impact by decreasing the inflammation state at local and systemic level and then improve the quality of life and the asthma control. Indeed, synbiotic have been shown to possess beneficial effects on the immune system.', 'detailedDescription': 'Thirty percent of asthmatic patients are not well controlled even with an optimal treatment. There is then a need for new therapeutics allowing a better asthma control. Synbiotic (association of probiotics and prebiotics) have been shown to have anti-inflammatory properties as well as immunomodulatory activities. Moreover, synbiotic appeared to be very well tolerated and safe.\n\nOne hundred severe asthmatic patients (ACQ\\> 1.5 and beclomethasone \\> 200 µg per day) will receive "Probiotical ®/Bactecal®" (3 pills a day, content: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill) or a placebo during 3 months.\n\nThey will be evaluated before and 1-3-6 months after the first administration and different tests will be realized:\n\n* lung function tests (spirometry, lung volumes, diffusing capacity)\n* exhaled nitric oxide value (FeNo, linked to airway eosinophilia)\n* blood tests: leucocyte count, c reactive protein, fibrinogen. Plasma and serum will be kept for inflammatory mediators measurements.\n* sputum induction: leucocyte count and mediators measurements using the sputum supernatant and sputum cells.\n* bronchial reactivity (bronchial challenge test)\n* microvascular health: to assess the glycocalyx state, see: http://glycocheck.com/ for details.\n* questionnaires: asthma control test (ACT), asthma control questionnaire (ACQ), asthma quality of life questionnaire (AQLQ ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe asthma (ACQ \\>1.5 and treatment = minimum 200 µg beclomethasone) and stable treatment for at least 3 months.\n\nExclusion Criteria:\n\n* treatment not stable\n* exacerbation state\n* infection'}, 'identificationModule': {'nctId': 'NCT03341403', 'briefTitle': 'Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Assessment of the Impact of a Dietary Supplement Synbiotic "Probiotical ®/Bactecal®" in Asthma', 'orgStudyIdInfo': {'id': '2017-248'}, 'secondaryIdInfos': [{'id': 'B707201733638', 'type': 'OTHER', 'domain': 'clinicaltrials.be'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synbiotic group', 'description': 'severe asthmatic patients (ACQ\\> 1.5 and beclomethasone \\> 200 µg per day) will receive "Probiotical ®/Bactecal®" (3 pills a day, content: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill) during 3 months.', 'interventionNames': ['Dietary Supplement: Probiotical®/Bactecal®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'severe asthmatic patients (ACQ\\> 1.5 and beclomethasone \\> 200 µg per day) will receive a placebo (3 pills a day) during 3 months.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Probiotical®/Bactecal®', 'type': 'DIETARY_SUPPLEMENT', 'description': '"Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.', 'armGroupLabels': ['Synbiotic group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'pills containing placebo', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'University Hospital of Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Renaud Louis, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU-ULG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renaud Louis', 'investigatorAffiliation': 'University of Liege'}}}}