Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-31 @ 6:49 PM
Study NCT ID:
NCT06808867
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2025-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double-blind'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2025-01-30', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Digestive Quality of Life Questionnaire (DQLQ) scores', 'timeFrame': 'from enrollment to end of study at 8 weeks', 'description': 'To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group'}, {'measure': 'Changes in Symptom Severity Score (Diary)', 'timeFrame': 'from enrollment to end of study at 8 weeks', 'description': 'Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group'}], 'secondaryOutcomes': [{'measure': 'Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores', 'timeFrame': 'from enrollment to end of study at 8 weeks', 'description': 'To assess changes in gastrointestinal symptoms comparing active supplement to placebo group'}, {'measure': 'Changes in Stool Consistency (Bristol Stool Scale)', 'timeFrame': 'from enrollment to end of study at 8 weeks', 'description': 'Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.\n\nStudy Primary Objective:\n\n• To assess improvement in bloating symptoms\n\nStudy Secondary Objectives:\n\n* To assess safety and tolerability of the formulation\n* To compare the time taken for perceptual improvement in bloating/distention\n* Enzyme blood assays\n* To assess quality of life indices'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent to participate in the study.\n* Willingness to actively participate in the study and to come to the scheduled visits.\n* Female and/or male\n* From 18 to 85 years of age\n* Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks\n\nExclusion Criteria:\n\n* Drug addicts, alcoholics.\n* AIDS, HIV-positive or infectious hepatitis\n* Diabetes mellitus\n* Disorders known to affect GI motility such as gastroparesis or amyloidosis.\n* Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac disease\n* History of surgery known to alter the normal function of the GI tract.\n* Conditions which exclude participation or might influence the test reaction/evaluation.\n* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.\n* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.\n* Documented allergies to cosmetic products and/or ingredients\n* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) within the last 6 weeks prior to the start of the study and/or throughout the entire course of the study.\n* Oral steroids within the last 4 weeks prior to the start of the study and/or throughout the entire course of the study\n* Oral or systemic therapy with antibiotics within the last 3 months prior to the start of the study and/or throughout the entire course of the study\n* Subjects who were treated with biologics within the last 6 months prior to the start of the study and/or throughout the entire course of the study.\n* One of the following illnesses if not medicated: cardiovascular diseases, thyroid hyperfunction, asthma, hypertension.'}, 'identificationModule': {'nctId': 'NCT06808867', 'briefTitle': 'Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olly, PBC'}, 'officialTitle': 'A 6-week Randomized, Double-blind, Comparative Clinical Study of the Efficacy of an Oral Product in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and Gastrointestinal Symptoms', 'orgStudyIdInfo': {'id': 'UNLV20231116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Supplement with Active Ingredient Blend', 'description': 'Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning.', 'interventionNames': ['Dietary Supplement: Dietary Supplement with Active Ingredient Blend']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eligible subjects will receive Placebo to take daily for six weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Dietary Supplement with Active Ingredient Blend', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eligible subjects will receive Active supplement to take daily for six weeks', 'armGroupLabels': ['Dietary Supplement with Active Ingredient Blend']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94127', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'See Final Report', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olly, PBC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}