Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
Study NCT ID:
NCT06717659
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Probiotics in Pulmonaty Rehabilitation for COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'interleukin-6', 'timeFrame': 'six weeks', 'description': 'inflammation evaluation'}], 'secondaryOutcomes': [{'measure': 'indirect calorimetry', 'timeFrame': 'six weeks', 'description': 'nutrition status'}, {'measure': 'body composition analysis', 'timeFrame': 'six weeks', 'description': 'nutrition status'}, {'measure': 'heart rate', 'timeFrame': 'six weeks', 'description': 'physiological parameters'}, {'measure': 'saturation', 'timeFrame': 'six weeks', 'description': 'physiological parameters'}, {'measure': 'systolic and diastolic pressure', 'timeFrame': 'six weeks', 'description': 'physiological parameters'}, {'measure': 'respiratory rate', 'timeFrame': 'six weeks', 'description': 'physiological parameters'}, {'measure': 'six minute walk test', 'timeFrame': 'six weeks', 'description': 'functional performance'}, {'measure': 'time up and go', 'timeFrame': 'six weeks', 'description': 'functional performance'}, {'measure': 'FEV1', 'timeFrame': 'six weeks', 'description': 'functional performance'}, {'measure': 'FVC', 'timeFrame': 'six weeks', 'description': 'functional performance'}, {'measure': 'FEV1/FVC', 'timeFrame': 'six weeks', 'description': 'functional performance'}, {'measure': 'CRP', 'timeFrame': 'six weeks', 'description': 'biochemical blood tests'}, {'measure': 'TNF-α', 'timeFrame': 'six weeks', 'description': 'biochemical blood tests'}, {'measure': 'TMAO', 'timeFrame': 'six weeks', 'description': 'biochemical blood tests'}, {'measure': 'The MDA of oxidative stress', 'timeFrame': 'six weeks', 'description': 'biochemical blood tests'}, {'measure': 'modified medical research council', 'timeFrame': 'six weeks', 'description': 'self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome'}, {'measure': 'COPD assessment test', 'timeFrame': 'six weeks', 'description': 'self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome'}, {'measure': 'Borg dyspnea scale', 'timeFrame': 'six weeks', 'description': 'self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['body composition', 'inflammation markers', 'nutritional supplementation', 'probiotics', 'chronic obstructive pulmonary disease'], 'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)', 'Probiotic Intervention', 'Body Composition Measurement']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.', 'detailedDescription': 'Background： Patients with chronic obstructive pulmonary disease (COPD) often suffer from malnutrition and weight loss, which negatively impact mortality rates. Research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in COPD. Malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. Nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in COPD patients.\n\nStudy Design： This is a one-year, single-center, prospective randomized controlled trial.\n\nMethods： This study is a randomized controlled trial targeting COPD patients undergoing pulmonary rehabilitation. The plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. The study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. Data will be analyzed using SPSS, with statistical significance set at p \\< 0.05.\n\nEffect： The trial expects that COPD patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance.\n\nKey words： Chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to sign a written informed consent form.\n* Diagnosed with pre-COPD or COPD stage I-IV according to the 2023 GOLD guidelines.\n* Undergoing pulmonary rehabilitation therapy for more than three months.\n\nExclusion Criteria:\n\n* Under 18 years old.\n* Diagnosed with neuromuscular diseases.\n* Experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months.\n* Unable to cooperate with cardiopulmonary exercise testing.\n* Has other diseases or behavioral restrictions preventing participation in exercise training for over one year.\n* Assessed by a physician to have severe malnutrition or a significantly low BMI.'}, 'identificationModule': {'nctId': 'NCT06717659', 'briefTitle': 'Probiotics in Pulmonaty Rehabilitation for COPD', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'Probiotics in the Management of Pulmonary Rehabilitation for COPD: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FJUH113385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'probiotic group', 'description': 'receive probiotics alongside standard pulmonary rehabilitation therapy', 'interventionNames': ['Other: probiotic supplementation intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pulmonary rehabilitation group', 'description': 'undergo only the standard pulmonary rehabilitation program', 'interventionNames': ['Other: standard pulmonnary rehabilitation']}], 'interventions': [{'name': 'probiotic supplementation intervention', 'type': 'OTHER', 'description': 'probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy', 'armGroupLabels': ['probiotic group']}, {'name': 'standard pulmonnary rehabilitation', 'type': 'OTHER', 'description': 'undergo routine pulmonary rehabilitation without probiotics intervention', 'armGroupLabels': ['pulmonary rehabilitation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'C00152@mail.fjuh.fju.edu.tw', 'phone': '+886-905-301-879'}, {'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT'}], 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'C00152@mail.fjuh.fju.edu.tw', 'phone': '+886-905-301-879'}], 'overallOfficials': [{'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Jen Catholic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}