Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04552002
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2020-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic markers', 'timeFrame': '6 months', 'description': 'HbA1c, FBG (through blood samples)'}, {'measure': 'Inflammatory markers', 'timeFrame': '6 months', 'description': 'IL-1, IL-10, CRP, IFN-γ (through blood samples)'}, {'measure': 'Body Composition parameters', 'timeFrame': '6 months', 'description': 'Muscle mass, Fat mass (through a body composition analyzer)'}, {'measure': 'BMI', 'timeFrame': '6 months', 'description': 'Height and weight will be measured to obtain BMI (kg/m2)'}, {'measure': 'Waist circumference', 'timeFrame': '6 months', 'description': 'in (cm) by a measurement tape'}], 'secondaryOutcomes': [{'measure': 'Microbiome sequencing', 'timeFrame': '6 months', 'description': 'Will be obtained through stool samples'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Supplements']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial that will be conducted on Saudi prediabetic and diabetic adults aged 18 to 70 years. The aim of the study is to investigate the effect of synbiotic consumption on gut microbiome, glycemic control, and other diabetes-related outcomes in patients with prediabetes and diabetes. A total of 160 participants will be recruited from King Fahd Hospital of the University, Eastern Province, Saudi Arabia and randomly assigned to synbiotic group (prediabetic and diabetic, n=40 each group) or control group (prediabetic and diabetic, n=40 each group) for a 6-month trial. A structured questionnaire will be used for data collection from subjects. The questionnaire will include data related to socioeconomic status, health and diet related history. Primary outcomes including gut microbiome sequencing, glycemic control related parameters and secondary outcomes including inflammatory markers, food intolerance and anthropometric measurements will be measured before the study, after 3 months and after 6 months. The findings of the current study will shed light on the significance of synbiotic consumption on glycemic control and other diabetes-related outcomes and their relation to food allergy and autoimmunity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with type 1 diabetes\n* Patients on insulin therapy\n* Patients on antibiotics\n* Pregnant and lactating women\n* Smoking individuals\n* Patients with comorbidities (except for hyperlipidemia and blood pressure)\n* Patients taking immunosuppressants\n* Patients taking probiotics, prebiotics or synbiotics\n\nExclusion Criteria:\n\n* Patients with prediabetes (HbA1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl)\n* Patients with type 2 diabetes (HbA1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl\n* Male and female patients aged (18-70) years\n* Patients with HbA1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl\n* BMI ≥ 25'}, 'identificationModule': {'nctId': 'NCT04552002', 'briefTitle': 'The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients: A Double Blinded Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IRB-2019-03-227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synbiotic group', 'description': 'Intervention group:\n\nWill receive synbiotic supplements: one capsule/day. Each capsule contains 20 billion CFU multi-strain probiotics + prebiotics (inulin and oligosaccharides) for a duration of 6 months.', 'interventionNames': ['Dietary Supplement: Synbiotic group']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo group', 'description': 'Will receive a placebo. The placebo will be similar to the synbiotic supplements in appearance.'}], 'interventions': [{'name': 'Synbiotic group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotics and prebiotics', 'armGroupLabels': ['Synbiotic group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dammam', 'state': 'Eastern Province', 'country': 'Saudi Arabia', 'facility': 'Family Medicince Community Centre', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}, {'city': 'Dammam', 'state': 'Eastern Province', 'country': 'Saudi Arabia', 'facility': 'King Fahd University Hospital', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Razan Algarni', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}