Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT05226520
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2021-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychophysiological Effects of Probiotic Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Unique coding'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Exploratory, randomized, placebo-controlled, 2-arms, double-blinded, parallel'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary cortisol level', 'timeFrame': 'Before the stressor (time-point -20 minutes) and after the stressor (time-point +0 min, time-point +5 min, time-point +10 min, time-point +20 min, time-point +30 min, time-point +40 min) at both baseline and after 6 weeks of treatment', 'description': 'Salivary cortisol levels (nmol/L) before and after stressor'}], 'secondaryOutcomes': [{'measure': 'Cortisol level from waking saliva samples', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Cortisol level (nmol/L) from waking saliva samples collected 0, 15, 30, 45, 60 min after waking'}, {'measure': 'Mean heart rate variability', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Mean heart rate variability in the time (ms) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc'}, {'measure': 'Heart frequency', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Heart frequency (Hz) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc'}, {'measure': 'Mean skin conductance level', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Mean skin conductance level (SCL, kΩ) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc'}, {'measure': 'Self-reported measures before and after the stressor (PANAS)', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Positive and negative affect scores (1-50) computed with the Positive and Negative Affect Schedule (PANAS)'}, {'measure': 'Self-reported measures before and after the stressor (STAI-6)', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Likert scores (1-4) for 6 mood dimensions: calm, tense, upset, relaxed, content, worry from the State Trait Anxiety Inventory 6-item short form (STAI-6)'}, {'measure': 'Self-reported measures before, during and after the stressor (VAS)', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'VAS scores in mm (0-100) for subjective perception of the stress induction'}, {'measure': 'Self-reported endpoints from standard questionnaires (PSS)', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Perceived stress score (0-56) computed from the Perceived Stress Scale (PSS)'}, {'measure': 'Self-reported endpoints from standard questionnaires (HADs)', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Scores (0-21) of depression and anxiety computed from the Hospital Anxiety and Depression scale (HADs)'}, {'measure': 'Self-reported endpoints from standard questionnaires (GSRS)', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Scores from the Gastrointestinal Symptom-Rating Scale (GSRS): scores range from 1 to 7 and higher scores represent more discomfort'}, {'measure': 'Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality)', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Sleep quality score from the Pittsburgh Sleep Quality Index questionnaire (score 0-21: the lower, the better sleep quality)'}, {'measure': 'Probiotic in feces', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Probiotic quantity in feces (genome copy number / million 16S copy number)'}, {'measure': 'Microbiome related metabolites in stool, blood and urine', 'timeFrame': 'Baseline and after 6 weeks treatment', 'description': 'Microbiome related metabolites in stool, blood and urine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild to Moderate Levels of Stress']}, 'descriptionModule': {'briefSummary': 'This is a pilot exploratory study to investigate the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.', 'detailedDescription': 'The purpose of the study is to explore the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.\n\nThe objectives is three:\n\n* Measure the effects of a 6-week supplementation with NCC3001 on psychological and physiological parameters in response to an acute experimental stress;\n* Measure the effects of a 6-week supplementation with NCC3001 on chronic stress level, gastro-intestinal symptoms and sleep quality;\n* Explore changes in the profiles of biological parameters associated with ingestion of NCC3001; including changes in hormones, neurotransmitters, circulating immune and microbiome-derived molecules and changes in the microbiome itself'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand and sign the informed consent\n2. Healthy adult men and/or women aged 25 to 65 years old\n3. Mild to moderate stress, defined as a score in the range of 15 to 25 on the validated Depression, Anxiety and Stress Scale (DASS-42)\n4. Proficiency in French and/or English\n5. Normal visual acuity and hearing with or without correction (self-reported)\n6. BMI in the range of 18.5 to 29.9 kg/m2\n\nExclusion Criteria:\n\n1. Diagnosed food allergies\n2. Currently participating or having recently participated in a clinical study with products potentially interfering with the results as judged by the investigator\n3. Organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids\n4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily\n5. Concurrent diagnosed systemic chronic disease (e.g., endocrine, cardiovascular, metabolic, liver, celiac)\n6. Willing to avoid the consumption of probiotic-containing products (including yogurts containing probiotics) i.e. any commercially available product specified as containing Lactobacillus, Bifidobacteria, Streptococcus or Saccharomyces for the 2 weeks prior to randomization visit\n7. Willing to avoid the use of antibiotics in the 4 weeks prior to randomization visit\n8. Adherence to an overly unbalanced diet such as vegan, paleo, ketogenic, low carbohydrate, raw diets\n9. Conditions that may affect mood'}, 'identificationModule': {'nctId': 'NCT05226520', 'briefTitle': 'Psychophysiological Effects of Probiotic Supplementation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of 6-week Probiotic Supplementation on Stress-related Parameters in Healthy Adults With Different Levels of Stress', 'orgStudyIdInfo': {'id': '2004NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic NCC3001', 'description': 'Sachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks', 'interventionNames': ['Dietary Supplement: Experimental probiotic product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matched Placebo Comparator', 'description': 'Sachets of matching placebo containing maltodextrin, yeast extract, cystein HCl and pea flour to be administered orally every day for 6 weeks', 'interventionNames': ['Other: Placebo comparator']}], 'interventions': [{'name': 'Experimental probiotic product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic supplementation', 'armGroupLabels': ['Probiotic NCC3001']}, {'name': 'Placebo comparator', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Matched Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Nestlé Research', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Catherine Macé', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nestlé Institute of Health Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}